HIV

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than half of people living with HIV and suppressed viral loads nonetheless had imaging-confirmed coronary artery disease – and despite longtime use of HIV drugs that have been associated with cardiovascular trouble, none of those drugs were implicated in disease risk in this study.

“Traditional risk factors and duration of HIV infection were associated with severe coronary artery disease,” said Andreas Knudsen, MD, PhD, an infectious disease provider at Copenhagen University Hospital, Hvidovre, Denmark, during his presentation at the 18th European AIDS Conference. “When we adjusted for time since diagnosis of HIV, none of the drugs remained associated with the severity of coronary artery disease.”

Notably, that included abacavir, which was found in another EACS presentation and in past research to be associated with increased rates of heart attacks. Abacavir is sold individually as a generic as well as a component of Epzicom (abacavir/lamivudine) and the single-drug regimen Triumeq (dolutegravir/abacavir/lamivudine).

The Copenhagen Comorbidity in HIV Infection (COCOMO) study enrolled 1,099 people living with HIV in the Danish capital beginning in 2015, and 705 of them had angiographies via CT available to include in the results. The participants were almost all male (89%), at a healthy weight (BMI of 25), and 96% had undetectable viral loads.

Large minorities of participants also had traditional risk factors for coronary artery disease. More than one in four smoked, one in five had high cholesterol, and 42% had high blood pressure. In addition, many had used drugs that have been associated with cardiovascular trouble, including abacavir, which 26% of participants had used; indinavir, used by 17% of participants; zidovudine/AZT, used by 47%; and didanosine, which 14% used. (While abacavir is still in use, the other three drugs are considered legacy drugs and are not in current use.)

In addition, nearly one in three (29%) were currently using a protease inhibitor, which has been associated with heart failure.

When the investigators looked at participants’ CTs, they found that, by the Coronary Artery Disease-Reporting and Data Systems (CAD-RAMS) scoring system, close to half (46%) had clear arteries with no signs of coronary artery disease. But that also meant that 54% had some blockage or stiffening of the arteries. The good news is that 27% of those people had minimal or mild coronary artery disease.

But a full 17% had confirmed obstructive coronary artery disease, and another 1 in 10 participants had the highest level of blockages. When they broke the data down by traditional and HIV medication–related risk factors for coronary artery disease, they found something interesting. Although obesity was associated with the presence of atherosclerosis, it wasn’t associated with severe disease. But diabetes was the reverse of that: It wasn’t associated with the presence of the disease, but it was associated with more severe disease.

And when they looked at abacavir, they found no relationship between the drug and atherosclerosis. “Abacavir was not associated with the presence of atherosclerosis and was also not associated with severity of disease,” said Dr. Knudsen.

Although past use of AZT, indinavir, and didanosine were associated with severity of atherosclerosis, that association went away when Dr. Knudsen and team adjusted the findings for time since diagnosis. What was associated atherosclerosis was length of time living with HIV itself. For every 5 years a person lived with HIV, the study found the risk of having any atherosclerosis increased 20% and severity increased 23%. In addition, being a man was associated with a nearly 2.5-times increased risk of having any atherosclerosis and a 96% increased chance of having more severe atherosclerosis. Having diabetes was associated with a nearly threefold increased risk of atherosclerosis, as was every additional decade of life for a person who was living with HIV.

The findings confirm the baseline data of the REPRIEVE trial, which recently released data showing similarly high rates of atherosclerotic plaque in people living with HIV who didn’t register as “at risk” for cardiovascular disease using traditional scoring methods.

“It’s important in that it’s a huge study that’s confirmatory [of] what we know, which is that there are high levels of subclinical coronary artery disease in people living with HIV,” said Steven Grinspoon, MD, professor at Harvard Medical School in Boston, Massachusetts, and principal investigator of REPRIEVE.

As for the lack of association between abacavir and cardiovascular risk, he said he’s taking the findings with a grain of salt.

“It’s hard to make a lot out of that,” he said. “It’s hard to know in a cross-sectional study. People put people on different things.”

In Spain, where Jose Ignacio Bernardino, MD, treats people living with HIV at La Paz University Hospital in Madrid, abacavir is mostly a moot point, as clinicians have long since moved away from maintaining people living with HIV on any abacavir-containing regimens. What’s more important in the study, he told this news organization, is that “worrisome” high level of risk. REPRIEVE will test whether statins can reduce heart disease events in people living with HIV. But in the meantime, he said the take-away for clinicians from the study is the primary importance of traditional cardiovascular risk factors.

“We have to acknowledge that the major cardiovascular risk factor is age,” he said. “When patients are approaching their 50s, I usually try to stress a lot about cardiovascular risk factors in general. I stress healthy lifestyle – get physical exercise, hypertension, glucose, lipids – in every single patient.”

Dr. Knudsen and Dr. Bernardino have disclosed no relevant financial relationships. Dr. Grinspoon reports receiving personal and consulting fees from Theratechnologies and ViiV Healthcare.

A version of this article first appeared on Medscape.com.

More than half of people living with HIV and suppressed viral loads nonetheless had imaging-confirmed coronary artery disease – and despite longtime use of HIV drugs that have been associated with cardiovascular trouble, none of those drugs were implicated in disease risk in this study.

“Traditional risk factors and duration of HIV infection were associated with severe coronary artery disease,” said Andreas Knudsen, MD, PhD, an infectious disease provider at Copenhagen University Hospital, Hvidovre, Denmark, during his presentation at the 18th European AIDS Conference. “When we adjusted for time since diagnosis of HIV, none of the drugs remained associated with the severity of coronary artery disease.”

Notably, that included abacavir, which was found in another EACS presentation and in past research to be associated with increased rates of heart attacks. Abacavir is sold individually as a generic as well as a component of Epzicom (abacavir/lamivudine) and the single-drug regimen Triumeq (dolutegravir/abacavir/lamivudine).

The Copenhagen Comorbidity in HIV Infection (COCOMO) study enrolled 1,099 people living with HIV in the Danish capital beginning in 2015, and 705 of them had angiographies via CT available to include in the results. The participants were almost all male (89%), at a healthy weight (BMI of 25), and 96% had undetectable viral loads.

Large minorities of participants also had traditional risk factors for coronary artery disease. More than one in four smoked, one in five had high cholesterol, and 42% had high blood pressure. In addition, many had used drugs that have been associated with cardiovascular trouble, including abacavir, which 26% of participants had used; indinavir, used by 17% of participants; zidovudine/AZT, used by 47%; and didanosine, which 14% used. (While abacavir is still in use, the other three drugs are considered legacy drugs and are not in current use.)

In addition, nearly one in three (29%) were currently using a protease inhibitor, which has been associated with heart failure.

When the investigators looked at participants’ CTs, they found that, by the Coronary Artery Disease-Reporting and Data Systems (CAD-RAMS) scoring system, close to half (46%) had clear arteries with no signs of coronary artery disease. But that also meant that 54% had some blockage or stiffening of the arteries. The good news is that 27% of those people had minimal or mild coronary artery disease.

But a full 17% had confirmed obstructive coronary artery disease, and another 1 in 10 participants had the highest level of blockages. When they broke the data down by traditional and HIV medication–related risk factors for coronary artery disease, they found something interesting. Although obesity was associated with the presence of atherosclerosis, it wasn’t associated with severe disease. But diabetes was the reverse of that: It wasn’t associated with the presence of the disease, but it was associated with more severe disease.

And when they looked at abacavir, they found no relationship between the drug and atherosclerosis. “Abacavir was not associated with the presence of atherosclerosis and was also not associated with severity of disease,” said Dr. Knudsen.

Although past use of AZT, indinavir, and didanosine were associated with severity of atherosclerosis, that association went away when Dr. Knudsen and team adjusted the findings for time since diagnosis. What was associated atherosclerosis was length of time living with HIV itself. For every 5 years a person lived with HIV, the study found the risk of having any atherosclerosis increased 20% and severity increased 23%. In addition, being a man was associated with a nearly 2.5-times increased risk of having any atherosclerosis and a 96% increased chance of having more severe atherosclerosis. Having diabetes was associated with a nearly threefold increased risk of atherosclerosis, as was every additional decade of life for a person who was living with HIV.

The findings confirm the baseline data of the REPRIEVE trial, which recently released data showing similarly high rates of atherosclerotic plaque in people living with HIV who didn’t register as “at risk” for cardiovascular disease using traditional scoring methods.

“It’s important in that it’s a huge study that’s confirmatory [of] what we know, which is that there are high levels of subclinical coronary artery disease in people living with HIV,” said Steven Grinspoon, MD, professor at Harvard Medical School in Boston, Massachusetts, and principal investigator of REPRIEVE.

As for the lack of association between abacavir and cardiovascular risk, he said he’s taking the findings with a grain of salt.

“It’s hard to make a lot out of that,” he said. “It’s hard to know in a cross-sectional study. People put people on different things.”

In Spain, where Jose Ignacio Bernardino, MD, treats people living with HIV at La Paz University Hospital in Madrid, abacavir is mostly a moot point, as clinicians have long since moved away from maintaining people living with HIV on any abacavir-containing regimens. What’s more important in the study, he told this news organization, is that “worrisome” high level of risk. REPRIEVE will test whether statins can reduce heart disease events in people living with HIV. But in the meantime, he said the take-away for clinicians from the study is the primary importance of traditional cardiovascular risk factors.

“We have to acknowledge that the major cardiovascular risk factor is age,” he said. “When patients are approaching their 50s, I usually try to stress a lot about cardiovascular risk factors in general. I stress healthy lifestyle – get physical exercise, hypertension, glucose, lipids – in every single patient.”

Dr. Knudsen and Dr. Bernardino have disclosed no relevant financial relationships. Dr. Grinspoon reports receiving personal and consulting fees from Theratechnologies and ViiV Healthcare.

A version of this article first appeared on Medscape.com.

More than half of people living with HIV and suppressed viral loads nonetheless had imaging-confirmed coronary artery disease – and despite longtime use of HIV drugs that have been associated with cardiovascular trouble, none of those drugs were implicated in disease risk in this study.

“Traditional risk factors and duration of HIV infection were associated with severe coronary artery disease,” said Andreas Knudsen, MD, PhD, an infectious disease provider at Copenhagen University Hospital, Hvidovre, Denmark, during his presentation at the 18th European AIDS Conference. “When we adjusted for time since diagnosis of HIV, none of the drugs remained associated with the severity of coronary artery disease.”

Notably, that included abacavir, which was found in another EACS presentation and in past research to be associated with increased rates of heart attacks. Abacavir is sold individually as a generic as well as a component of Epzicom (abacavir/lamivudine) and the single-drug regimen Triumeq (dolutegravir/abacavir/lamivudine).

The Copenhagen Comorbidity in HIV Infection (COCOMO) study enrolled 1,099 people living with HIV in the Danish capital beginning in 2015, and 705 of them had angiographies via CT available to include in the results. The participants were almost all male (89%), at a healthy weight (BMI of 25), and 96% had undetectable viral loads.

Large minorities of participants also had traditional risk factors for coronary artery disease. More than one in four smoked, one in five had high cholesterol, and 42% had high blood pressure. In addition, many had used drugs that have been associated with cardiovascular trouble, including abacavir, which 26% of participants had used; indinavir, used by 17% of participants; zidovudine/AZT, used by 47%; and didanosine, which 14% used. (While abacavir is still in use, the other three drugs are considered legacy drugs and are not in current use.)

In addition, nearly one in three (29%) were currently using a protease inhibitor, which has been associated with heart failure.

When the investigators looked at participants’ CTs, they found that, by the Coronary Artery Disease-Reporting and Data Systems (CAD-RAMS) scoring system, close to half (46%) had clear arteries with no signs of coronary artery disease. But that also meant that 54% had some blockage or stiffening of the arteries. The good news is that 27% of those people had minimal or mild coronary artery disease.

But a full 17% had confirmed obstructive coronary artery disease, and another 1 in 10 participants had the highest level of blockages. When they broke the data down by traditional and HIV medication–related risk factors for coronary artery disease, they found something interesting. Although obesity was associated with the presence of atherosclerosis, it wasn’t associated with severe disease. But diabetes was the reverse of that: It wasn’t associated with the presence of the disease, but it was associated with more severe disease.

And when they looked at abacavir, they found no relationship between the drug and atherosclerosis. “Abacavir was not associated with the presence of atherosclerosis and was also not associated with severity of disease,” said Dr. Knudsen.

Although past use of AZT, indinavir, and didanosine were associated with severity of atherosclerosis, that association went away when Dr. Knudsen and team adjusted the findings for time since diagnosis. What was associated atherosclerosis was length of time living with HIV itself. For every 5 years a person lived with HIV, the study found the risk of having any atherosclerosis increased 20% and severity increased 23%. In addition, being a man was associated with a nearly 2.5-times increased risk of having any atherosclerosis and a 96% increased chance of having more severe atherosclerosis. Having diabetes was associated with a nearly threefold increased risk of atherosclerosis, as was every additional decade of life for a person who was living with HIV.

The findings confirm the baseline data of the REPRIEVE trial, which recently released data showing similarly high rates of atherosclerotic plaque in people living with HIV who didn’t register as “at risk” for cardiovascular disease using traditional scoring methods.

“It’s important in that it’s a huge study that’s confirmatory [of] what we know, which is that there are high levels of subclinical coronary artery disease in people living with HIV,” said Steven Grinspoon, MD, professor at Harvard Medical School in Boston, Massachusetts, and principal investigator of REPRIEVE.

As for the lack of association between abacavir and cardiovascular risk, he said he’s taking the findings with a grain of salt.

“It’s hard to make a lot out of that,” he said. “It’s hard to know in a cross-sectional study. People put people on different things.”

In Spain, where Jose Ignacio Bernardino, MD, treats people living with HIV at La Paz University Hospital in Madrid, abacavir is mostly a moot point, as clinicians have long since moved away from maintaining people living with HIV on any abacavir-containing regimens. What’s more important in the study, he told this news organization, is that “worrisome” high level of risk. REPRIEVE will test whether statins can reduce heart disease events in people living with HIV. But in the meantime, he said the take-away for clinicians from the study is the primary importance of traditional cardiovascular risk factors.

“We have to acknowledge that the major cardiovascular risk factor is age,” he said. “When patients are approaching their 50s, I usually try to stress a lot about cardiovascular risk factors in general. I stress healthy lifestyle – get physical exercise, hypertension, glucose, lipids – in every single patient.”

Dr. Knudsen and Dr. Bernardino have disclosed no relevant financial relationships. Dr. Grinspoon reports receiving personal and consulting fees from Theratechnologies and ViiV Healthcare.

A version of this article first appeared on Medscape.com.

The MAVMET study, the first randomized controlled trial of maraviroc (Selzentry) with or without metformin, failed to reduce liver fat in people living with HIV and nonalcoholic fatty liver disease compared with placebo – and in some cases, prolonged use actually increased liver fat.

And that means clinicians like Yvonne Gilleece, MB BCh, who was not involved in the study but does run a liver clinic in England for people living with HIV, are returning to the one intervention proven to work. “As yet, the only thing that is proven to have a very positive effect that is published is weight loss,” said Dr. Gilleece, who runs the clinic at Brighton and Sussex University Hospital. “You don’t put someone on these particular drugs, particularly this combination, easily. MAVMET has really demonstrated that, actually, it’s not effective, and it’s not particularly beneficial to patients.”

The MAVMET trial data was presented at the 18th European AIDS Conference,

There was good reason to think maraviroc might work. A 2018 study in the journal Hepatology found that one of maraviroc’s molecular cousins, cenicriviroc, significantly reduced fibrosis in people with NAFLD. Dr. Gilleece is co-investigator of another study of maraviroc in NAFLD, the HEPMARC trial, which is wrapping up now. In addition to those studies, there are other potential treatments in ongoing trials, including semaglutide, which is being studied in the United States under the study name SLIM LIVER.

MAVMET enrolled 90 people living with HIV from six clinical sites in London who were 35 or older and who had at least one marker for NAFLD, such as abnormal liver lab results. But 70% qualified via imaging- and/or biopsy-confirmed NAFLD. Almost all participants (93%) were men and 81% were White. The trial excluded people who were pregnant or breastfeeding. The median age was 52, and the participants met the criteria for overweight but not obesity, with a median BMI of 28.

In other words, participants generally had fatty livers without the inflammation that characterizes the more aggressive nonalcoholic steatohepatitis (NASH). Clinicians can’t yet differentiate between those who will continue to have asymptomatic fatty liver and those who will progress to NASH and potentially need a liver transplant.

All people living with HIV in the trial had undetectable viral loads and were on HIV treatment. Nearly 1 in 5 (19%) were using a treatment regimen containing tenofovir alafenamide (TAF), which has been associated with weight gain. Nearly half were on integrase strand inhibitors.

Investigators divided the participants up into four groups: 24 people stayed on their HIV treatment and added nothing else; 23 people took maraviroc only; 21 took metformin only; and the final group took both maraviroc and metformin. Across groups, liver fat at baseline was 8.9%, and 78% had mild hepatic steatosis.

After taking the medications for 48 weeks, participants returned to clinic to be scanned via MRI proton density fat fraction (MRI-PDFF), which has been found to successfully measure liver fat. However, because of the COVID-19 pandemic, 20 of the 83 people who returned to the clinic came later than 48 weeks after the trial began.

When investigators looked at the results, they didn’t see what they hypothesized, said Sarah Pett, professor of infectious diseases at University College, London: The scatter plot graph of change in weight looked, well, scattershot: People who didn’t take any additional treatment sometimes lost more liver fat than those on treatment. In fact, the mean liver fat percentage rose by 2.2% in the maraviroc group, 1.3% in the metformin group, and 0.8% in the combination group. The control group saw an increase of 1.4% – meaning that there was no difference between the change in fat between those on treatment and those not.

What’s more, those who had delayed scans – and stayed on their treatment for a median of an additional 16 weeks – saw their liver fat increase even more.

In an interview, Dr. Pett called the results “disappointing.” “The numbers are quite small, but we still didn’t expect this,” she said. “It’s not explained by lockdown weight gain, although we still have to look in detail at how alcohol consumption could have contributed.”

There were also some limits to what the design of this particular trial could tell the researchers. For instance, nearly half of the participants in the maraviroc group, a third of the people in the metformin group, and 36% of those in the combination group had hepatic steatosis grades of 0, meaning that their livers were healthy. And MRI-PDFF becomes less reliable at that level.

“One of the regrets is that perhaps we should have done FibroScan [ultrasound], as well,” Dr. Pett said. The consequence is that the study may have undercounted the fat level by using MRI-PFDD.

“This suggests that the surrogate markers of NAFLD used in MAVMET were not very sensitive to those with a higher percentage of fat,” Dr. Pett said during her presentation. “We were really trying to be pragmatic and not require an MRI at screening.”

Whatever the case, she said that the failure of this particular treatment just highlights the growing need to look more seriously, and more collaboratively, at fat and liver health in people living with HIV.

“We need to really focus on setting up large cohorts of people living with HIV to look in a rigorous way at weight gain, changes in waist circumference, ectopic fat, capture fatty liver disease index scores, and cardiovascular risk, to acquire some longitudinal data,” she said. “And [we need to] join with our fellow researchers in overweight and obesity medicine and hepatology to make sure that people living with HIV are included in new treatments for NASH, as several large RCTs have excluded [people living with HIV].”

From Dr. Gilleece’s perspective, it also just speaks to how far the field has to go in identifying those with asymptomatic fatty livers from those who will progress to fibrosis and potentially need liver transplants.

“MAVMET shows the difficulty in managing NAFLD,” she said. “It seems quite an innocuous disease, because for the majority of people it’s not going to cause a problem in their lifetime. But the reality is, for some it will, and we don’t really know how to treat it.”

Dr. Gilleece has disclosed no relevant financial relationships. Dr. Pett reported receiving funding for trials from Gilead Sciences and Janssen-Cilag. ViiV Healthcare funded the MAVMET trial.

A version of this article first appeared on Medscape.com.

The MAVMET study, the first randomized controlled trial of maraviroc (Selzentry) with or without metformin, failed to reduce liver fat in people living with HIV and nonalcoholic fatty liver disease compared with placebo – and in some cases, prolonged use actually increased liver fat.

And that means clinicians like Yvonne Gilleece, MB BCh, who was not involved in the study but does run a liver clinic in England for people living with HIV, are returning to the one intervention proven to work. “As yet, the only thing that is proven to have a very positive effect that is published is weight loss,” said Dr. Gilleece, who runs the clinic at Brighton and Sussex University Hospital. “You don’t put someone on these particular drugs, particularly this combination, easily. MAVMET has really demonstrated that, actually, it’s not effective, and it’s not particularly beneficial to patients.”

The MAVMET trial data was presented at the 18th European AIDS Conference,

There was good reason to think maraviroc might work. A 2018 study in the journal Hepatology found that one of maraviroc’s molecular cousins, cenicriviroc, significantly reduced fibrosis in people with NAFLD. Dr. Gilleece is co-investigator of another study of maraviroc in NAFLD, the HEPMARC trial, which is wrapping up now. In addition to those studies, there are other potential treatments in ongoing trials, including semaglutide, which is being studied in the United States under the study name SLIM LIVER.

MAVMET enrolled 90 people living with HIV from six clinical sites in London who were 35 or older and who had at least one marker for NAFLD, such as abnormal liver lab results. But 70% qualified via imaging- and/or biopsy-confirmed NAFLD. Almost all participants (93%) were men and 81% were White. The trial excluded people who were pregnant or breastfeeding. The median age was 52, and the participants met the criteria for overweight but not obesity, with a median BMI of 28.

In other words, participants generally had fatty livers without the inflammation that characterizes the more aggressive nonalcoholic steatohepatitis (NASH). Clinicians can’t yet differentiate between those who will continue to have asymptomatic fatty liver and those who will progress to NASH and potentially need a liver transplant.

All people living with HIV in the trial had undetectable viral loads and were on HIV treatment. Nearly 1 in 5 (19%) were using a treatment regimen containing tenofovir alafenamide (TAF), which has been associated with weight gain. Nearly half were on integrase strand inhibitors.

Investigators divided the participants up into four groups: 24 people stayed on their HIV treatment and added nothing else; 23 people took maraviroc only; 21 took metformin only; and the final group took both maraviroc and metformin. Across groups, liver fat at baseline was 8.9%, and 78% had mild hepatic steatosis.

After taking the medications for 48 weeks, participants returned to clinic to be scanned via MRI proton density fat fraction (MRI-PDFF), which has been found to successfully measure liver fat. However, because of the COVID-19 pandemic, 20 of the 83 people who returned to the clinic came later than 48 weeks after the trial began.

When investigators looked at the results, they didn’t see what they hypothesized, said Sarah Pett, professor of infectious diseases at University College, London: The scatter plot graph of change in weight looked, well, scattershot: People who didn’t take any additional treatment sometimes lost more liver fat than those on treatment. In fact, the mean liver fat percentage rose by 2.2% in the maraviroc group, 1.3% in the metformin group, and 0.8% in the combination group. The control group saw an increase of 1.4% – meaning that there was no difference between the change in fat between those on treatment and those not.

What’s more, those who had delayed scans – and stayed on their treatment for a median of an additional 16 weeks – saw their liver fat increase even more.

In an interview, Dr. Pett called the results “disappointing.” “The numbers are quite small, but we still didn’t expect this,” she said. “It’s not explained by lockdown weight gain, although we still have to look in detail at how alcohol consumption could have contributed.”

There were also some limits to what the design of this particular trial could tell the researchers. For instance, nearly half of the participants in the maraviroc group, a third of the people in the metformin group, and 36% of those in the combination group had hepatic steatosis grades of 0, meaning that their livers were healthy. And MRI-PDFF becomes less reliable at that level.

“One of the regrets is that perhaps we should have done FibroScan [ultrasound], as well,” Dr. Pett said. The consequence is that the study may have undercounted the fat level by using MRI-PFDD.

“This suggests that the surrogate markers of NAFLD used in MAVMET were not very sensitive to those with a higher percentage of fat,” Dr. Pett said during her presentation. “We were really trying to be pragmatic and not require an MRI at screening.”

Whatever the case, she said that the failure of this particular treatment just highlights the growing need to look more seriously, and more collaboratively, at fat and liver health in people living with HIV.

“We need to really focus on setting up large cohorts of people living with HIV to look in a rigorous way at weight gain, changes in waist circumference, ectopic fat, capture fatty liver disease index scores, and cardiovascular risk, to acquire some longitudinal data,” she said. “And [we need to] join with our fellow researchers in overweight and obesity medicine and hepatology to make sure that people living with HIV are included in new treatments for NASH, as several large RCTs have excluded [people living with HIV].”

From Dr. Gilleece’s perspective, it also just speaks to how far the field has to go in identifying those with asymptomatic fatty livers from those who will progress to fibrosis and potentially need liver transplants.

“MAVMET shows the difficulty in managing NAFLD,” she said. “It seems quite an innocuous disease, because for the majority of people it’s not going to cause a problem in their lifetime. But the reality is, for some it will, and we don’t really know how to treat it.”

Dr. Gilleece has disclosed no relevant financial relationships. Dr. Pett reported receiving funding for trials from Gilead Sciences and Janssen-Cilag. ViiV Healthcare funded the MAVMET trial.

A version of this article first appeared on Medscape.com.

The MAVMET study, the first randomized controlled trial of maraviroc (Selzentry) with or without metformin, failed to reduce liver fat in people living with HIV and nonalcoholic fatty liver disease compared with placebo – and in some cases, prolonged use actually increased liver fat.

And that means clinicians like Yvonne Gilleece, MB BCh, who was not involved in the study but does run a liver clinic in England for people living with HIV, are returning to the one intervention proven to work. “As yet, the only thing that is proven to have a very positive effect that is published is weight loss,” said Dr. Gilleece, who runs the clinic at Brighton and Sussex University Hospital. “You don’t put someone on these particular drugs, particularly this combination, easily. MAVMET has really demonstrated that, actually, it’s not effective, and it’s not particularly beneficial to patients.”

The MAVMET trial data was presented at the 18th European AIDS Conference,

There was good reason to think maraviroc might work. A 2018 study in the journal Hepatology found that one of maraviroc’s molecular cousins, cenicriviroc, significantly reduced fibrosis in people with NAFLD. Dr. Gilleece is co-investigator of another study of maraviroc in NAFLD, the HEPMARC trial, which is wrapping up now. In addition to those studies, there are other potential treatments in ongoing trials, including semaglutide, which is being studied in the United States under the study name SLIM LIVER.

MAVMET enrolled 90 people living with HIV from six clinical sites in London who were 35 or older and who had at least one marker for NAFLD, such as abnormal liver lab results. But 70% qualified via imaging- and/or biopsy-confirmed NAFLD. Almost all participants (93%) were men and 81% were White. The trial excluded people who were pregnant or breastfeeding. The median age was 52, and the participants met the criteria for overweight but not obesity, with a median BMI of 28.

In other words, participants generally had fatty livers without the inflammation that characterizes the more aggressive nonalcoholic steatohepatitis (NASH). Clinicians can’t yet differentiate between those who will continue to have asymptomatic fatty liver and those who will progress to NASH and potentially need a liver transplant.

All people living with HIV in the trial had undetectable viral loads and were on HIV treatment. Nearly 1 in 5 (19%) were using a treatment regimen containing tenofovir alafenamide (TAF), which has been associated with weight gain. Nearly half were on integrase strand inhibitors.

Investigators divided the participants up into four groups: 24 people stayed on their HIV treatment and added nothing else; 23 people took maraviroc only; 21 took metformin only; and the final group took both maraviroc and metformin. Across groups, liver fat at baseline was 8.9%, and 78% had mild hepatic steatosis.

After taking the medications for 48 weeks, participants returned to clinic to be scanned via MRI proton density fat fraction (MRI-PDFF), which has been found to successfully measure liver fat. However, because of the COVID-19 pandemic, 20 of the 83 people who returned to the clinic came later than 48 weeks after the trial began.

When investigators looked at the results, they didn’t see what they hypothesized, said Sarah Pett, professor of infectious diseases at University College, London: The scatter plot graph of change in weight looked, well, scattershot: People who didn’t take any additional treatment sometimes lost more liver fat than those on treatment. In fact, the mean liver fat percentage rose by 2.2% in the maraviroc group, 1.3% in the metformin group, and 0.8% in the combination group. The control group saw an increase of 1.4% – meaning that there was no difference between the change in fat between those on treatment and those not.

What’s more, those who had delayed scans – and stayed on their treatment for a median of an additional 16 weeks – saw their liver fat increase even more.

In an interview, Dr. Pett called the results “disappointing.” “The numbers are quite small, but we still didn’t expect this,” she said. “It’s not explained by lockdown weight gain, although we still have to look in detail at how alcohol consumption could have contributed.”

There were also some limits to what the design of this particular trial could tell the researchers. For instance, nearly half of the participants in the maraviroc group, a third of the people in the metformin group, and 36% of those in the combination group had hepatic steatosis grades of 0, meaning that their livers were healthy. And MRI-PDFF becomes less reliable at that level.

“One of the regrets is that perhaps we should have done FibroScan [ultrasound], as well,” Dr. Pett said. The consequence is that the study may have undercounted the fat level by using MRI-PFDD.

“This suggests that the surrogate markers of NAFLD used in MAVMET were not very sensitive to those with a higher percentage of fat,” Dr. Pett said during her presentation. “We were really trying to be pragmatic and not require an MRI at screening.”

Whatever the case, she said that the failure of this particular treatment just highlights the growing need to look more seriously, and more collaboratively, at fat and liver health in people living with HIV.

“We need to really focus on setting up large cohorts of people living with HIV to look in a rigorous way at weight gain, changes in waist circumference, ectopic fat, capture fatty liver disease index scores, and cardiovascular risk, to acquire some longitudinal data,” she said. “And [we need to] join with our fellow researchers in overweight and obesity medicine and hepatology to make sure that people living with HIV are included in new treatments for NASH, as several large RCTs have excluded [people living with HIV].”

From Dr. Gilleece’s perspective, it also just speaks to how far the field has to go in identifying those with asymptomatic fatty livers from those who will progress to fibrosis and potentially need liver transplants.

“MAVMET shows the difficulty in managing NAFLD,” she said. “It seems quite an innocuous disease, because for the majority of people it’s not going to cause a problem in their lifetime. But the reality is, for some it will, and we don’t really know how to treat it.”

Dr. Gilleece has disclosed no relevant financial relationships. Dr. Pett reported receiving funding for trials from Gilead Sciences and Janssen-Cilag. ViiV Healthcare funded the MAVMET trial.

A version of this article first appeared on Medscape.com.

A firestorm of controversy over access to HIV medications and protection against discriminatory insurance practices has been making its way through U.S. district courts for the past 3 years, pitting HIV patients against pharmacy benefits managers and, ostensibly, the healthcare industry itself.

The case, CVS Pharmacy Inc. v. Doe, scheduled for oral arguments before the Supreme Court of the United States (SCOTUS) in December, is a weighty one for patients with HIV and the practitioners caring for them.

At odds are whether or not mandatory mail-order requirements for specialty medications violate specific provisions of the Patient Protection and Affordable Care Act (ACA) and the Rehabilitation Act of 1973, both of which prohibit discrimination by programs that receive federal funds.

An amicus brief submitted on October 29 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School on behalf of five John Does and a number of medical practitioners and practitioner organizations underscores the degree to which advances in HIV treatment, viral suppression, and care linkage — not to mention the national mandate to end the AIDS epidemic by 2030 — might ultimately be affected.

“We decided to file the brief at the Supreme Court level because we wanted to make sure that the perspectives of people living with HIV, their providers, and advocates were in the record,” Maryanne Tomazic, a clinical instructor at CHLPI, toldthis news organization.

“It’s important for the court to consider why robust access to prescription drug coverage and pharmacy services are so important for people living with HIV, and why it’s not appropriate to compromise access to antiretroviral therapy,” she explained.
 

A bitter pill, regardless of who swallows it

CVS Pharmacy Inc. v. Doe focuses on a legal concept known as “disparate impact discrimination,” which refers to a policy that appears neutral but unintentionally discriminates against a protected class of people (eg, on the basis of sex, age, or ethnicity).

The Supreme Court’s decision in the case will address a central question: did CVS Pharmacy, Caremark, and Caremark Specialty Pharmacy (“CVS”) discriminate against the respondents by requiring that they obtain specialty medications (including those for HIV) by mail order or drop shipment for pickup, or, alternatively, pay out-of-network prices for these medications at non-CVS pharmacies?

The decision will also address whether the ACA’s inclusion of clause 504 of the Rehabilitation Act, which prohibits protected class discrimination, allows patients to challenge terms and conditions of their healthcare plans, a decision that has broad and far-reaching implications for insurers’ abilities to set plan restrictions and pricing.

A spokesperson for CVS declined to comment when contacted by this news organization but provided a link to an April 9, 2021 SCOTUS blog post about the filing. In its court filing, CVS contended that the program applies to all specialty medications (not just HIV) and simply reflects the cost/complexity of specialty medications.

Not everyone agrees that cost is the most important issue at play. Indeed, a critical take-away for practitioners is how mandated mail-order pharmacy programs can disrupt coordination of care.

“In the traditional model, the physician is talking to the pharmacists [or] talking with the patient, and you have kind of triangular communication model that helps not only the patient stay engaged in care but [also] allows the healthcare provider team to adjust the medication quickly without delay,” said Ms. Tomazic.

The John Doe statements in the original case highlight these concerns. They focus on how mandatory mail orders restrict highly personable relationships with local specialty pharmacists who are familiar with their patients’ medical histories as well as their medication dosing and adjustments and who regularly communicate with the complete care team on the patients’ behalf.

“JOHN DOE THREE and others depend on these types of long standing relationships with local pharmacists to maximize the benefits of HIV/AIDS medications and treat the complex and ever-changing needs of the HIV/AIDS patients,” wrote attorneys in the 2018 class action filing.

Other issues raised by the suit involve the following: privacy with respect to medication pickup; specialty care customer representatives’ lack of understanding and knowledge of HIV medications; incomplete prescription fills; late medication deliveries; exposure of medications to the elements; work and employment interruptions; and restrictions on early fills and reorders, which increase the risk for missed doses and potentially serious health problems, including interruptions in viral suppression and resistance.
 

Discrimination issues also raised

CHLPI’s amicus joins several others in support of the unique needs of persons with HIV, especially in Black and Hispanic/Latino communities, which are disproportionately affected by HIV.

A press release distributed by the National Association for the Advancement of Colored People Legal Defense and Educational Fund (LDF) reinforces the idea that not only are Black people more likely to have a disability other groups, owing to the country’s legacy of racial inequality, but also that they are likely to encounter unique forms of discrimination and specific barriers to full participation in society, further underscoring the need for disparate impact liability to address unfair policies and practices.

“Inequity in access to resources, including healthcare, further amplifies the instance and persistence of disabilities among Black people,” LDF attorneys wrote in the brief.

“We saw with COVID-19 that [mail-order prescription] programs can serve in a supportive role in access to care,” said Ms. Tomazic. “But we don’t want those programs to be mandated, and we don’t want to forget about communities where these kinds of programs are simply not a viable option,” she said.

Oral arguments in the case begin on December 7. A decision is expected some months later.

No relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

A firestorm of controversy over access to HIV medications and protection against discriminatory insurance practices has been making its way through U.S. district courts for the past 3 years, pitting HIV patients against pharmacy benefits managers and, ostensibly, the healthcare industry itself.

The case, CVS Pharmacy Inc. v. Doe, scheduled for oral arguments before the Supreme Court of the United States (SCOTUS) in December, is a weighty one for patients with HIV and the practitioners caring for them.

At odds are whether or not mandatory mail-order requirements for specialty medications violate specific provisions of the Patient Protection and Affordable Care Act (ACA) and the Rehabilitation Act of 1973, both of which prohibit discrimination by programs that receive federal funds.

An amicus brief submitted on October 29 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School on behalf of five John Does and a number of medical practitioners and practitioner organizations underscores the degree to which advances in HIV treatment, viral suppression, and care linkage — not to mention the national mandate to end the AIDS epidemic by 2030 — might ultimately be affected.

“We decided to file the brief at the Supreme Court level because we wanted to make sure that the perspectives of people living with HIV, their providers, and advocates were in the record,” Maryanne Tomazic, a clinical instructor at CHLPI, toldthis news organization.

“It’s important for the court to consider why robust access to prescription drug coverage and pharmacy services are so important for people living with HIV, and why it’s not appropriate to compromise access to antiretroviral therapy,” she explained.
 

A bitter pill, regardless of who swallows it

CVS Pharmacy Inc. v. Doe focuses on a legal concept known as “disparate impact discrimination,” which refers to a policy that appears neutral but unintentionally discriminates against a protected class of people (eg, on the basis of sex, age, or ethnicity).

The Supreme Court’s decision in the case will address a central question: did CVS Pharmacy, Caremark, and Caremark Specialty Pharmacy (“CVS”) discriminate against the respondents by requiring that they obtain specialty medications (including those for HIV) by mail order or drop shipment for pickup, or, alternatively, pay out-of-network prices for these medications at non-CVS pharmacies?

The decision will also address whether the ACA’s inclusion of clause 504 of the Rehabilitation Act, which prohibits protected class discrimination, allows patients to challenge terms and conditions of their healthcare plans, a decision that has broad and far-reaching implications for insurers’ abilities to set plan restrictions and pricing.

A spokesperson for CVS declined to comment when contacted by this news organization but provided a link to an April 9, 2021 SCOTUS blog post about the filing. In its court filing, CVS contended that the program applies to all specialty medications (not just HIV) and simply reflects the cost/complexity of specialty medications.

Not everyone agrees that cost is the most important issue at play. Indeed, a critical take-away for practitioners is how mandated mail-order pharmacy programs can disrupt coordination of care.

“In the traditional model, the physician is talking to the pharmacists [or] talking with the patient, and you have kind of triangular communication model that helps not only the patient stay engaged in care but [also] allows the healthcare provider team to adjust the medication quickly without delay,” said Ms. Tomazic.

The John Doe statements in the original case highlight these concerns. They focus on how mandatory mail orders restrict highly personable relationships with local specialty pharmacists who are familiar with their patients’ medical histories as well as their medication dosing and adjustments and who regularly communicate with the complete care team on the patients’ behalf.

“JOHN DOE THREE and others depend on these types of long standing relationships with local pharmacists to maximize the benefits of HIV/AIDS medications and treat the complex and ever-changing needs of the HIV/AIDS patients,” wrote attorneys in the 2018 class action filing.

Other issues raised by the suit involve the following: privacy with respect to medication pickup; specialty care customer representatives’ lack of understanding and knowledge of HIV medications; incomplete prescription fills; late medication deliveries; exposure of medications to the elements; work and employment interruptions; and restrictions on early fills and reorders, which increase the risk for missed doses and potentially serious health problems, including interruptions in viral suppression and resistance.
 

Discrimination issues also raised

CHLPI’s amicus joins several others in support of the unique needs of persons with HIV, especially in Black and Hispanic/Latino communities, which are disproportionately affected by HIV.

A press release distributed by the National Association for the Advancement of Colored People Legal Defense and Educational Fund (LDF) reinforces the idea that not only are Black people more likely to have a disability other groups, owing to the country’s legacy of racial inequality, but also that they are likely to encounter unique forms of discrimination and specific barriers to full participation in society, further underscoring the need for disparate impact liability to address unfair policies and practices.

“Inequity in access to resources, including healthcare, further amplifies the instance and persistence of disabilities among Black people,” LDF attorneys wrote in the brief.

“We saw with COVID-19 that [mail-order prescription] programs can serve in a supportive role in access to care,” said Ms. Tomazic. “But we don’t want those programs to be mandated, and we don’t want to forget about communities where these kinds of programs are simply not a viable option,” she said.

Oral arguments in the case begin on December 7. A decision is expected some months later.

No relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

A firestorm of controversy over access to HIV medications and protection against discriminatory insurance practices has been making its way through U.S. district courts for the past 3 years, pitting HIV patients against pharmacy benefits managers and, ostensibly, the healthcare industry itself.

The case, CVS Pharmacy Inc. v. Doe, scheduled for oral arguments before the Supreme Court of the United States (SCOTUS) in December, is a weighty one for patients with HIV and the practitioners caring for them.

At odds are whether or not mandatory mail-order requirements for specialty medications violate specific provisions of the Patient Protection and Affordable Care Act (ACA) and the Rehabilitation Act of 1973, both of which prohibit discrimination by programs that receive federal funds.

An amicus brief submitted on October 29 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School on behalf of five John Does and a number of medical practitioners and practitioner organizations underscores the degree to which advances in HIV treatment, viral suppression, and care linkage — not to mention the national mandate to end the AIDS epidemic by 2030 — might ultimately be affected.

“We decided to file the brief at the Supreme Court level because we wanted to make sure that the perspectives of people living with HIV, their providers, and advocates were in the record,” Maryanne Tomazic, a clinical instructor at CHLPI, toldthis news organization.

“It’s important for the court to consider why robust access to prescription drug coverage and pharmacy services are so important for people living with HIV, and why it’s not appropriate to compromise access to antiretroviral therapy,” she explained.
 

A bitter pill, regardless of who swallows it

CVS Pharmacy Inc. v. Doe focuses on a legal concept known as “disparate impact discrimination,” which refers to a policy that appears neutral but unintentionally discriminates against a protected class of people (eg, on the basis of sex, age, or ethnicity).

The Supreme Court’s decision in the case will address a central question: did CVS Pharmacy, Caremark, and Caremark Specialty Pharmacy (“CVS”) discriminate against the respondents by requiring that they obtain specialty medications (including those for HIV) by mail order or drop shipment for pickup, or, alternatively, pay out-of-network prices for these medications at non-CVS pharmacies?

The decision will also address whether the ACA’s inclusion of clause 504 of the Rehabilitation Act, which prohibits protected class discrimination, allows patients to challenge terms and conditions of their healthcare plans, a decision that has broad and far-reaching implications for insurers’ abilities to set plan restrictions and pricing.

A spokesperson for CVS declined to comment when contacted by this news organization but provided a link to an April 9, 2021 SCOTUS blog post about the filing. In its court filing, CVS contended that the program applies to all specialty medications (not just HIV) and simply reflects the cost/complexity of specialty medications.

Not everyone agrees that cost is the most important issue at play. Indeed, a critical take-away for practitioners is how mandated mail-order pharmacy programs can disrupt coordination of care.

“In the traditional model, the physician is talking to the pharmacists [or] talking with the patient, and you have kind of triangular communication model that helps not only the patient stay engaged in care but [also] allows the healthcare provider team to adjust the medication quickly without delay,” said Ms. Tomazic.

The John Doe statements in the original case highlight these concerns. They focus on how mandatory mail orders restrict highly personable relationships with local specialty pharmacists who are familiar with their patients’ medical histories as well as their medication dosing and adjustments and who regularly communicate with the complete care team on the patients’ behalf.

“JOHN DOE THREE and others depend on these types of long standing relationships with local pharmacists to maximize the benefits of HIV/AIDS medications and treat the complex and ever-changing needs of the HIV/AIDS patients,” wrote attorneys in the 2018 class action filing.

Other issues raised by the suit involve the following: privacy with respect to medication pickup; specialty care customer representatives’ lack of understanding and knowledge of HIV medications; incomplete prescription fills; late medication deliveries; exposure of medications to the elements; work and employment interruptions; and restrictions on early fills and reorders, which increase the risk for missed doses and potentially serious health problems, including interruptions in viral suppression and resistance.
 

Discrimination issues also raised

CHLPI’s amicus joins several others in support of the unique needs of persons with HIV, especially in Black and Hispanic/Latino communities, which are disproportionately affected by HIV.

A press release distributed by the National Association for the Advancement of Colored People Legal Defense and Educational Fund (LDF) reinforces the idea that not only are Black people more likely to have a disability other groups, owing to the country’s legacy of racial inequality, but also that they are likely to encounter unique forms of discrimination and specific barriers to full participation in society, further underscoring the need for disparate impact liability to address unfair policies and practices.

“Inequity in access to resources, including healthcare, further amplifies the instance and persistence of disabilities among Black people,” LDF attorneys wrote in the brief.

“We saw with COVID-19 that [mail-order prescription] programs can serve in a supportive role in access to care,” said Ms. Tomazic. “But we don’t want those programs to be mandated, and we don’t want to forget about communities where these kinds of programs are simply not a viable option,” she said.

Oral arguments in the case begin on December 7. A decision is expected some months later.

No relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

Nearly one in three gay and bisexual men who were diagnosed with HIV at U.K. sexual health clinics didn’t meet the criteria for “high risk” that would signal to a clinician that they would be good candidates for pre-exposure prophylaxis (PrEP).

And that means that people who appear lower risk may still be good candidates for the HIV prevention pills, said Ann Sullivan, MD, consulting physician at Chelsea and Westminster Hospital, London.

“If people are coming forward for PrEP, they have self-identified that they need PrEP, [and] we should be allowing them to take PrEP,” said Dr. Sullivan at the 18th European AIDS Society Conference (EACS 2021). “We just need to trust patients. People know their risk, and we just have to accept that they know what they need best.”

And while this trial was made up of 95% gay and bisexual men, that ethos applies to every other group that could benefit from PrEP, including cisgender and transgender women and other gender-diverse people, Latinos, and Black Americans. In the United States, these groups make up nearly half of those who could benefit from PrEP under older guidelines but account for just 8% of people currently taking PrEP.

The finding also reinforces growing calls from health care providers to reduce gatekeeping around PrEP. For instance, there’s a move underway by the U.S. Centers for Disease Control and Prevention, where drafts of updated PrEP guidelines call for clinicians to talk to any sexually active teenager and adult about PrEP.

For the PrEP Impact trial, gay and bisexual men who received sexual health care at UK National Health Service sexual health clinics were invited to enroll in the study based on national PrEP guidelines. Those guidelines included being a cisgender man who had had sex with men not currently living with HIV and reporting condomless anal sex in the last 3 months; having a male partner whose HIV status they don’t know or who doesn’t have an undetectable viral load and with whom they’ve had condomless anal sex; or someone who doesn’t reach those criteria but whom the clinician thinks would be a good candidate.

Between Oct. 2017 and Feb. 2020, a total of 17,770 gay and bisexual men and 503 transgender or nonbinary people enrolled in the trial and were paired with 97,098 gay and bisexual men who didn’t use PrEP. (Data from the transgender participants were reported in a separate presentation.) The median age was 27 years, with 14.4% of the cisgender gay men between the ages of 16 and 24. Three out of four cis men were White, most lived in London, and more than half came from very-low-income neighborhoods.

Participants and controls were assessed for whether they were at particularly high risk for acquiring HIV, such as having used PrEP, having had two or more HIV tests, having had a rectal bacterial sexually transmitted infection (STI), or having had contact with someone with HIV or syphilis.

At the end of Feb. 2020, 24 cisgender men on PrEP had acquired HIV compared with 670 in the control group – an 87% reduction in HIV acquisition. Only one of those 24 cis men had lab-confirmed high adherence to PrEP. However, because the hair samples used to judge drug concentration weren’t long enough, Dr. Sullivan and colleagues were unable to assess whether the person really was fully adherent to treatment for the length of the trial.

But when they looked at the assessed behavior of people who acquired HIV, the two groups diverged. While a full 92% of people using PrEP had had STI diagnoses and other markers of increased risk, that was true for only 71% of people not taking PrEP. That meant, Dr. Sullivan said in an interview, that screening guidelines for PrEP were missing 29% of people with low assessed risk for HIV who nevertheless acquired the virus.

The findings led Antonio Urbina, MD, who both prescribes PrEP and manages Mount Sinai Medical Center’s PrEP program in New York, to the same conclusion that Dr. Sullivan and her team came to: that no screener is going to account for everything, and that there may be things that patients don’t want to tell their clinicians about their risk, either because of their own internalized stigma or their calculation that they aren’t comfortable enough with their providers to be honest.

“It reinforces to me that I need to ask more open-ended questions regarding risk and then just talk more about PrEP,” said Dr. Urbina, professor of medicine at Icahn School of Medicine. “Risk is dynamic and changes. And the great thing about PrEP is that if the risk goes up or down, if you have PrEP on board, you maintain this protection against HIV.”

An accompanying presentation on the transgender and nonbinary participants in the Impact Trial found that just one of 503 PrEP users acquired HIV. But here, too, there were people who could have benefited from PrEP but didn’t take it: Of the 477 trans and nonbinary participants who acted as controls, 97 were eligible by current guidelines but didn’t take PrEP. One in four of those declined the offer to take PrEP; the rest weren’t able to take it because they lived outside the treatment area. That, combined with a significantly lower likelihood that Black trans and nonbinary people took PrEP, indicated that work needs to be done to address the needs of people geographically and ethnically.

The data on gay men also raised the “who’s left out” issue for Gina Simoncini, MD, medical director for the Philadelphia AIDS Healthcare Foundation Healthcare Center. Dr. Simoncini previously taught attending physicians at Temple University how to prescribe PrEP and has done many grand rounds for primary care providers on how to manage PrEP.

“My biggest issue with this data is: What about the people who aren’t going to sexual health clinics?” she said. “What about the kid who’s 16 and maybe just barely putting his feet into the waters of sex and doesn’t feel quite comfortable going to a sexual health clinic? What about the trans Indian girl who can’t get to sexual health clinics because of family stigma and cultural stigma? The more we move toward primary care, the more people need to get on board with this.”

Dr. Sullivan reports no relevant financial relationships. Dr. Simoncini is an employee of AIDS Healthcare Foundation and has received advisory board fees from ViiV Healthcare. Dr. Urbina sits on the scientific advisory councils for Gilead Sciences, ViiV Healthcare, and Merck.

A version of this article first appeared on Medscape.com.

Nearly one in three gay and bisexual men who were diagnosed with HIV at U.K. sexual health clinics didn’t meet the criteria for “high risk” that would signal to a clinician that they would be good candidates for pre-exposure prophylaxis (PrEP).

And that means that people who appear lower risk may still be good candidates for the HIV prevention pills, said Ann Sullivan, MD, consulting physician at Chelsea and Westminster Hospital, London.

“If people are coming forward for PrEP, they have self-identified that they need PrEP, [and] we should be allowing them to take PrEP,” said Dr. Sullivan at the 18th European AIDS Society Conference (EACS 2021). “We just need to trust patients. People know their risk, and we just have to accept that they know what they need best.”

And while this trial was made up of 95% gay and bisexual men, that ethos applies to every other group that could benefit from PrEP, including cisgender and transgender women and other gender-diverse people, Latinos, and Black Americans. In the United States, these groups make up nearly half of those who could benefit from PrEP under older guidelines but account for just 8% of people currently taking PrEP.

The finding also reinforces growing calls from health care providers to reduce gatekeeping around PrEP. For instance, there’s a move underway by the U.S. Centers for Disease Control and Prevention, where drafts of updated PrEP guidelines call for clinicians to talk to any sexually active teenager and adult about PrEP.

For the PrEP Impact trial, gay and bisexual men who received sexual health care at UK National Health Service sexual health clinics were invited to enroll in the study based on national PrEP guidelines. Those guidelines included being a cisgender man who had had sex with men not currently living with HIV and reporting condomless anal sex in the last 3 months; having a male partner whose HIV status they don’t know or who doesn’t have an undetectable viral load and with whom they’ve had condomless anal sex; or someone who doesn’t reach those criteria but whom the clinician thinks would be a good candidate.

Between Oct. 2017 and Feb. 2020, a total of 17,770 gay and bisexual men and 503 transgender or nonbinary people enrolled in the trial and were paired with 97,098 gay and bisexual men who didn’t use PrEP. (Data from the transgender participants were reported in a separate presentation.) The median age was 27 years, with 14.4% of the cisgender gay men between the ages of 16 and 24. Three out of four cis men were White, most lived in London, and more than half came from very-low-income neighborhoods.

Participants and controls were assessed for whether they were at particularly high risk for acquiring HIV, such as having used PrEP, having had two or more HIV tests, having had a rectal bacterial sexually transmitted infection (STI), or having had contact with someone with HIV or syphilis.

At the end of Feb. 2020, 24 cisgender men on PrEP had acquired HIV compared with 670 in the control group – an 87% reduction in HIV acquisition. Only one of those 24 cis men had lab-confirmed high adherence to PrEP. However, because the hair samples used to judge drug concentration weren’t long enough, Dr. Sullivan and colleagues were unable to assess whether the person really was fully adherent to treatment for the length of the trial.

But when they looked at the assessed behavior of people who acquired HIV, the two groups diverged. While a full 92% of people using PrEP had had STI diagnoses and other markers of increased risk, that was true for only 71% of people not taking PrEP. That meant, Dr. Sullivan said in an interview, that screening guidelines for PrEP were missing 29% of people with low assessed risk for HIV who nevertheless acquired the virus.

The findings led Antonio Urbina, MD, who both prescribes PrEP and manages Mount Sinai Medical Center’s PrEP program in New York, to the same conclusion that Dr. Sullivan and her team came to: that no screener is going to account for everything, and that there may be things that patients don’t want to tell their clinicians about their risk, either because of their own internalized stigma or their calculation that they aren’t comfortable enough with their providers to be honest.

“It reinforces to me that I need to ask more open-ended questions regarding risk and then just talk more about PrEP,” said Dr. Urbina, professor of medicine at Icahn School of Medicine. “Risk is dynamic and changes. And the great thing about PrEP is that if the risk goes up or down, if you have PrEP on board, you maintain this protection against HIV.”

An accompanying presentation on the transgender and nonbinary participants in the Impact Trial found that just one of 503 PrEP users acquired HIV. But here, too, there were people who could have benefited from PrEP but didn’t take it: Of the 477 trans and nonbinary participants who acted as controls, 97 were eligible by current guidelines but didn’t take PrEP. One in four of those declined the offer to take PrEP; the rest weren’t able to take it because they lived outside the treatment area. That, combined with a significantly lower likelihood that Black trans and nonbinary people took PrEP, indicated that work needs to be done to address the needs of people geographically and ethnically.

The data on gay men also raised the “who’s left out” issue for Gina Simoncini, MD, medical director for the Philadelphia AIDS Healthcare Foundation Healthcare Center. Dr. Simoncini previously taught attending physicians at Temple University how to prescribe PrEP and has done many grand rounds for primary care providers on how to manage PrEP.

“My biggest issue with this data is: What about the people who aren’t going to sexual health clinics?” she said. “What about the kid who’s 16 and maybe just barely putting his feet into the waters of sex and doesn’t feel quite comfortable going to a sexual health clinic? What about the trans Indian girl who can’t get to sexual health clinics because of family stigma and cultural stigma? The more we move toward primary care, the more people need to get on board with this.”

Dr. Sullivan reports no relevant financial relationships. Dr. Simoncini is an employee of AIDS Healthcare Foundation and has received advisory board fees from ViiV Healthcare. Dr. Urbina sits on the scientific advisory councils for Gilead Sciences, ViiV Healthcare, and Merck.

A version of this article first appeared on Medscape.com.

Nearly one in three gay and bisexual men who were diagnosed with HIV at U.K. sexual health clinics didn’t meet the criteria for “high risk” that would signal to a clinician that they would be good candidates for pre-exposure prophylaxis (PrEP).

And that means that people who appear lower risk may still be good candidates for the HIV prevention pills, said Ann Sullivan, MD, consulting physician at Chelsea and Westminster Hospital, London.

“If people are coming forward for PrEP, they have self-identified that they need PrEP, [and] we should be allowing them to take PrEP,” said Dr. Sullivan at the 18th European AIDS Society Conference (EACS 2021). “We just need to trust patients. People know their risk, and we just have to accept that they know what they need best.”

And while this trial was made up of 95% gay and bisexual men, that ethos applies to every other group that could benefit from PrEP, including cisgender and transgender women and other gender-diverse people, Latinos, and Black Americans. In the United States, these groups make up nearly half of those who could benefit from PrEP under older guidelines but account for just 8% of people currently taking PrEP.

The finding also reinforces growing calls from health care providers to reduce gatekeeping around PrEP. For instance, there’s a move underway by the U.S. Centers for Disease Control and Prevention, where drafts of updated PrEP guidelines call for clinicians to talk to any sexually active teenager and adult about PrEP.

For the PrEP Impact trial, gay and bisexual men who received sexual health care at UK National Health Service sexual health clinics were invited to enroll in the study based on national PrEP guidelines. Those guidelines included being a cisgender man who had had sex with men not currently living with HIV and reporting condomless anal sex in the last 3 months; having a male partner whose HIV status they don’t know or who doesn’t have an undetectable viral load and with whom they’ve had condomless anal sex; or someone who doesn’t reach those criteria but whom the clinician thinks would be a good candidate.

Between Oct. 2017 and Feb. 2020, a total of 17,770 gay and bisexual men and 503 transgender or nonbinary people enrolled in the trial and were paired with 97,098 gay and bisexual men who didn’t use PrEP. (Data from the transgender participants were reported in a separate presentation.) The median age was 27 years, with 14.4% of the cisgender gay men between the ages of 16 and 24. Three out of four cis men were White, most lived in London, and more than half came from very-low-income neighborhoods.

Participants and controls were assessed for whether they were at particularly high risk for acquiring HIV, such as having used PrEP, having had two or more HIV tests, having had a rectal bacterial sexually transmitted infection (STI), or having had contact with someone with HIV or syphilis.

At the end of Feb. 2020, 24 cisgender men on PrEP had acquired HIV compared with 670 in the control group – an 87% reduction in HIV acquisition. Only one of those 24 cis men had lab-confirmed high adherence to PrEP. However, because the hair samples used to judge drug concentration weren’t long enough, Dr. Sullivan and colleagues were unable to assess whether the person really was fully adherent to treatment for the length of the trial.

But when they looked at the assessed behavior of people who acquired HIV, the two groups diverged. While a full 92% of people using PrEP had had STI diagnoses and other markers of increased risk, that was true for only 71% of people not taking PrEP. That meant, Dr. Sullivan said in an interview, that screening guidelines for PrEP were missing 29% of people with low assessed risk for HIV who nevertheless acquired the virus.

The findings led Antonio Urbina, MD, who both prescribes PrEP and manages Mount Sinai Medical Center’s PrEP program in New York, to the same conclusion that Dr. Sullivan and her team came to: that no screener is going to account for everything, and that there may be things that patients don’t want to tell their clinicians about their risk, either because of their own internalized stigma or their calculation that they aren’t comfortable enough with their providers to be honest.

“It reinforces to me that I need to ask more open-ended questions regarding risk and then just talk more about PrEP,” said Dr. Urbina, professor of medicine at Icahn School of Medicine. “Risk is dynamic and changes. And the great thing about PrEP is that if the risk goes up or down, if you have PrEP on board, you maintain this protection against HIV.”

An accompanying presentation on the transgender and nonbinary participants in the Impact Trial found that just one of 503 PrEP users acquired HIV. But here, too, there were people who could have benefited from PrEP but didn’t take it: Of the 477 trans and nonbinary participants who acted as controls, 97 were eligible by current guidelines but didn’t take PrEP. One in four of those declined the offer to take PrEP; the rest weren’t able to take it because they lived outside the treatment area. That, combined with a significantly lower likelihood that Black trans and nonbinary people took PrEP, indicated that work needs to be done to address the needs of people geographically and ethnically.

The data on gay men also raised the “who’s left out” issue for Gina Simoncini, MD, medical director for the Philadelphia AIDS Healthcare Foundation Healthcare Center. Dr. Simoncini previously taught attending physicians at Temple University how to prescribe PrEP and has done many grand rounds for primary care providers on how to manage PrEP.

“My biggest issue with this data is: What about the people who aren’t going to sexual health clinics?” she said. “What about the kid who’s 16 and maybe just barely putting his feet into the waters of sex and doesn’t feel quite comfortable going to a sexual health clinic? What about the trans Indian girl who can’t get to sexual health clinics because of family stigma and cultural stigma? The more we move toward primary care, the more people need to get on board with this.”

Dr. Sullivan reports no relevant financial relationships. Dr. Simoncini is an employee of AIDS Healthcare Foundation and has received advisory board fees from ViiV Healthcare. Dr. Urbina sits on the scientific advisory councils for Gilead Sciences, ViiV Healthcare, and Merck.

A version of this article first appeared on Medscape.com.

One year into offering the first long-acting injectable HIV treatment to his patients, Jonathan Angel, MD, head of the division of infectious diseases at the University of Ottawa, reported that 15 of the 21 of patients who started on the regimen are still taking it, all with viral suppression. Those who weren’t cited a combination of inconvenience, injection site pain, and “injection fatigue.”

These are just a few things HIV providers are learning as they begin what Chloe Orkin, MD, professor of HIV medicine at Queen Mary University of London, called a paradigm shift to long-acting treatment, which may soon include not just shots but rings, implants, and microarray patches.

“It’s a paradigm shift, and we are at the very beginning of this paradigm shift,” said Dr. Orkin, commenting during the discussion session of the European AIDS Clinical Society 2021 annual meeting. “We’re having to change our model, and it’s challenging.”

In the United States, the Food and Drug Administration approved the first long-acting injectable, a combination of cabotegravir and rilpivirine (CAB/RIL; Cabenuva, ViiV Healthcare) in January 2021. But it has been approved in Canada since March 2020 and available at Dr. Angel’s clinic since November 2020. It’s also available in Canada as an every-other-month shot. Injected into the buttocks, the shot was found to be noninferior to standard daily oral treatment in many studies, including the ATLAS, the ATLAS-2M – which tested the every-other-month approach – and FLAIR trials.

Dr. Angel’s clinic was part of all three of those trials, so his clinic has had 5 years’ experience preparing for the change in workflow and the new approach the shots require.

Of the 21 people Dr. Angel has treated, 11 were white Canadians, nine were Black African, and one was Indigenous Canadian, with women making up a third of the participants. Median age was 51 years, and all patients had had undetectable viral loads before beginning the regimen. (Studies of the drug’s effectiveness in people who struggle to take daily pills are still ongoing.)

Most of those 21 patients had had undetectable viral loads for more than 5 years, but a few had been undetectable for only 6 months before beginning the shots. Their immune systems were also healthy, with a median CD4 count of 618 cells/mcL. As in the clinical trials, none of the participants had experienced antiretroviral treatment failure. Because public health insurers in Canada have yet to approve the shots, Dr. Angel’s patients receiving Cabenuva also have private health insurance. Up to 90% of people in Canada receive pharmaceutical coverage through public insurance; therefore, the shot is not yet widely available.

Twenty patients switched from integrase-inhibitor regimens, and one had been receiving a nonnucleoside reverse transcriptase inhibitor–based regimen before starting Cabenuva.

And although the drug has not been approved for shot initiation this way, two patients requested – and Dr. Angel agreed – to start them on the shots without first doing a month of daily pills to check for safety.

“This is my conclusion from these data: the oral lead-in period is not necessary,” Dr. Angel said in his presentation at the meeting. “It can provide some comfort to either a physician or a patient, but it does not seem to be medically necessary.”

That approach is not without data to back it up. Research presented at HIV Glasgow 2020 showed that people who switched from daily oral dolutegravir/abacavir/lamivudine straight to the injections did so without problems.

At last clinic visit, 15 of those 21 were still receiving the shots. None have experienced treatment failure, and all were still virally suppressed. Four participants left the trials and one more person opted to return to daily pills, citing some level of what Dr. Angel called “injection fatigue.”

“Just as we use the term ‘pill fatigue’ for patients who are tired of taking pills, patients do get tired of coming in monthly for their visits and injections,” he said. They find the trip to the clinic for the intramuscular injections “inconvenient,” he said.

Unlike in the United States, where Cabenuva is approved for only monthly injections, Health Canada has already approved the shot for every-other-month injections, which Dr. Angel said may reduce the odds of injection fatigue.

Dr. Angel’s presentation drew comments, questions, and excitement from the crowd. Annemarie Wensing, MD, assistant professor of medicine at University Medical Center Utrecht (the Netherlands), asked whether dispensing with the oral lead-in period could mean that these shots could be useful for people going on longer trips, people having surgeries where they can’t swallow pills, or in other scenarios.

“These are not hypothetical conversations,” Dr. Angel said. “I’m having these conversations with patients now – temporary use, they travel for 3 months and come back, can they go from injectable to oral to injectable.”

For now, he said, the answer is, “We’ll figure it out.”

Meanwhile, there’s another big question when it comes to injectables, said Marta Vas ylyev, MD, from Lviv (Ukraine) Regional AIDS Center: When will they be available to the people who might benefit most from them – people in resource-limited settings, people who so far have struggled to remember to take their pills every day?

For now, Dr. Angel replied, injectables continue to be a treatment only for those who are already doing well while receiving HIV treatment: those with already suppressed viral load, who are good at taking daily pills, and who are being treated at well-resourced clinics.

“There are huge obstacles to overcome if this is ever to be available [in resource-limited settings], and way more obstacles than there are with any oral therapies,” he said. “There’s not been much discussion here about the necessity of cold-chain requirements of pharmacies either centrally or locally, [or] the requirements of additional nurses or health care staff to administer the medication. So you’re looking at a very resource-intensive therapy, which now is fairly restrictive [as to] who will have access to it.”

Dr. Angel reports serving on advisory boards for ViiV Healthcare and Gilead Sciences and has done contract research for ViiV Healthcare, Gilead, and Merck. Dr. Orkin has received research grants, fees as a consultant, travel sponsorship, and speaker fees from ViiV, Merck, and GlaxoSmithKline. Dr. Vasylyev reported no relevant financial relationships.  

A version of this article first appeared on Medscape.com.

One year into offering the first long-acting injectable HIV treatment to his patients, Jonathan Angel, MD, head of the division of infectious diseases at the University of Ottawa, reported that 15 of the 21 of patients who started on the regimen are still taking it, all with viral suppression. Those who weren’t cited a combination of inconvenience, injection site pain, and “injection fatigue.”

These are just a few things HIV providers are learning as they begin what Chloe Orkin, MD, professor of HIV medicine at Queen Mary University of London, called a paradigm shift to long-acting treatment, which may soon include not just shots but rings, implants, and microarray patches.

“It’s a paradigm shift, and we are at the very beginning of this paradigm shift,” said Dr. Orkin, commenting during the discussion session of the European AIDS Clinical Society 2021 annual meeting. “We’re having to change our model, and it’s challenging.”

In the United States, the Food and Drug Administration approved the first long-acting injectable, a combination of cabotegravir and rilpivirine (CAB/RIL; Cabenuva, ViiV Healthcare) in January 2021. But it has been approved in Canada since March 2020 and available at Dr. Angel’s clinic since November 2020. It’s also available in Canada as an every-other-month shot. Injected into the buttocks, the shot was found to be noninferior to standard daily oral treatment in many studies, including the ATLAS, the ATLAS-2M – which tested the every-other-month approach – and FLAIR trials.

Dr. Angel’s clinic was part of all three of those trials, so his clinic has had 5 years’ experience preparing for the change in workflow and the new approach the shots require.

Of the 21 people Dr. Angel has treated, 11 were white Canadians, nine were Black African, and one was Indigenous Canadian, with women making up a third of the participants. Median age was 51 years, and all patients had had undetectable viral loads before beginning the regimen. (Studies of the drug’s effectiveness in people who struggle to take daily pills are still ongoing.)

Most of those 21 patients had had undetectable viral loads for more than 5 years, but a few had been undetectable for only 6 months before beginning the shots. Their immune systems were also healthy, with a median CD4 count of 618 cells/mcL. As in the clinical trials, none of the participants had experienced antiretroviral treatment failure. Because public health insurers in Canada have yet to approve the shots, Dr. Angel’s patients receiving Cabenuva also have private health insurance. Up to 90% of people in Canada receive pharmaceutical coverage through public insurance; therefore, the shot is not yet widely available.

Twenty patients switched from integrase-inhibitor regimens, and one had been receiving a nonnucleoside reverse transcriptase inhibitor–based regimen before starting Cabenuva.

And although the drug has not been approved for shot initiation this way, two patients requested – and Dr. Angel agreed – to start them on the shots without first doing a month of daily pills to check for safety.

“This is my conclusion from these data: the oral lead-in period is not necessary,” Dr. Angel said in his presentation at the meeting. “It can provide some comfort to either a physician or a patient, but it does not seem to be medically necessary.”

That approach is not without data to back it up. Research presented at HIV Glasgow 2020 showed that people who switched from daily oral dolutegravir/abacavir/lamivudine straight to the injections did so without problems.

At last clinic visit, 15 of those 21 were still receiving the shots. None have experienced treatment failure, and all were still virally suppressed. Four participants left the trials and one more person opted to return to daily pills, citing some level of what Dr. Angel called “injection fatigue.”

“Just as we use the term ‘pill fatigue’ for patients who are tired of taking pills, patients do get tired of coming in monthly for their visits and injections,” he said. They find the trip to the clinic for the intramuscular injections “inconvenient,” he said.

Unlike in the United States, where Cabenuva is approved for only monthly injections, Health Canada has already approved the shot for every-other-month injections, which Dr. Angel said may reduce the odds of injection fatigue.

Dr. Angel’s presentation drew comments, questions, and excitement from the crowd. Annemarie Wensing, MD, assistant professor of medicine at University Medical Center Utrecht (the Netherlands), asked whether dispensing with the oral lead-in period could mean that these shots could be useful for people going on longer trips, people having surgeries where they can’t swallow pills, or in other scenarios.

“These are not hypothetical conversations,” Dr. Angel said. “I’m having these conversations with patients now – temporary use, they travel for 3 months and come back, can they go from injectable to oral to injectable.”

For now, he said, the answer is, “We’ll figure it out.”

Meanwhile, there’s another big question when it comes to injectables, said Marta Vas ylyev, MD, from Lviv (Ukraine) Regional AIDS Center: When will they be available to the people who might benefit most from them – people in resource-limited settings, people who so far have struggled to remember to take their pills every day?

For now, Dr. Angel replied, injectables continue to be a treatment only for those who are already doing well while receiving HIV treatment: those with already suppressed viral load, who are good at taking daily pills, and who are being treated at well-resourced clinics.

“There are huge obstacles to overcome if this is ever to be available [in resource-limited settings], and way more obstacles than there are with any oral therapies,” he said. “There’s not been much discussion here about the necessity of cold-chain requirements of pharmacies either centrally or locally, [or] the requirements of additional nurses or health care staff to administer the medication. So you’re looking at a very resource-intensive therapy, which now is fairly restrictive [as to] who will have access to it.”

Dr. Angel reports serving on advisory boards for ViiV Healthcare and Gilead Sciences and has done contract research for ViiV Healthcare, Gilead, and Merck. Dr. Orkin has received research grants, fees as a consultant, travel sponsorship, and speaker fees from ViiV, Merck, and GlaxoSmithKline. Dr. Vasylyev reported no relevant financial relationships.  

A version of this article first appeared on Medscape.com.

One year into offering the first long-acting injectable HIV treatment to his patients, Jonathan Angel, MD, head of the division of infectious diseases at the University of Ottawa, reported that 15 of the 21 of patients who started on the regimen are still taking it, all with viral suppression. Those who weren’t cited a combination of inconvenience, injection site pain, and “injection fatigue.”

These are just a few things HIV providers are learning as they begin what Chloe Orkin, MD, professor of HIV medicine at Queen Mary University of London, called a paradigm shift to long-acting treatment, which may soon include not just shots but rings, implants, and microarray patches.

“It’s a paradigm shift, and we are at the very beginning of this paradigm shift,” said Dr. Orkin, commenting during the discussion session of the European AIDS Clinical Society 2021 annual meeting. “We’re having to change our model, and it’s challenging.”

In the United States, the Food and Drug Administration approved the first long-acting injectable, a combination of cabotegravir and rilpivirine (CAB/RIL; Cabenuva, ViiV Healthcare) in January 2021. But it has been approved in Canada since March 2020 and available at Dr. Angel’s clinic since November 2020. It’s also available in Canada as an every-other-month shot. Injected into the buttocks, the shot was found to be noninferior to standard daily oral treatment in many studies, including the ATLAS, the ATLAS-2M – which tested the every-other-month approach – and FLAIR trials.

Dr. Angel’s clinic was part of all three of those trials, so his clinic has had 5 years’ experience preparing for the change in workflow and the new approach the shots require.

Of the 21 people Dr. Angel has treated, 11 were white Canadians, nine were Black African, and one was Indigenous Canadian, with women making up a third of the participants. Median age was 51 years, and all patients had had undetectable viral loads before beginning the regimen. (Studies of the drug’s effectiveness in people who struggle to take daily pills are still ongoing.)

Most of those 21 patients had had undetectable viral loads for more than 5 years, but a few had been undetectable for only 6 months before beginning the shots. Their immune systems were also healthy, with a median CD4 count of 618 cells/mcL. As in the clinical trials, none of the participants had experienced antiretroviral treatment failure. Because public health insurers in Canada have yet to approve the shots, Dr. Angel’s patients receiving Cabenuva also have private health insurance. Up to 90% of people in Canada receive pharmaceutical coverage through public insurance; therefore, the shot is not yet widely available.

Twenty patients switched from integrase-inhibitor regimens, and one had been receiving a nonnucleoside reverse transcriptase inhibitor–based regimen before starting Cabenuva.

And although the drug has not been approved for shot initiation this way, two patients requested – and Dr. Angel agreed – to start them on the shots without first doing a month of daily pills to check for safety.

“This is my conclusion from these data: the oral lead-in period is not necessary,” Dr. Angel said in his presentation at the meeting. “It can provide some comfort to either a physician or a patient, but it does not seem to be medically necessary.”

That approach is not without data to back it up. Research presented at HIV Glasgow 2020 showed that people who switched from daily oral dolutegravir/abacavir/lamivudine straight to the injections did so without problems.

At last clinic visit, 15 of those 21 were still receiving the shots. None have experienced treatment failure, and all were still virally suppressed. Four participants left the trials and one more person opted to return to daily pills, citing some level of what Dr. Angel called “injection fatigue.”

“Just as we use the term ‘pill fatigue’ for patients who are tired of taking pills, patients do get tired of coming in monthly for their visits and injections,” he said. They find the trip to the clinic for the intramuscular injections “inconvenient,” he said.

Unlike in the United States, where Cabenuva is approved for only monthly injections, Health Canada has already approved the shot for every-other-month injections, which Dr. Angel said may reduce the odds of injection fatigue.

Dr. Angel’s presentation drew comments, questions, and excitement from the crowd. Annemarie Wensing, MD, assistant professor of medicine at University Medical Center Utrecht (the Netherlands), asked whether dispensing with the oral lead-in period could mean that these shots could be useful for people going on longer trips, people having surgeries where they can’t swallow pills, or in other scenarios.

“These are not hypothetical conversations,” Dr. Angel said. “I’m having these conversations with patients now – temporary use, they travel for 3 months and come back, can they go from injectable to oral to injectable.”

For now, he said, the answer is, “We’ll figure it out.”

Meanwhile, there’s another big question when it comes to injectables, said Marta Vas ylyev, MD, from Lviv (Ukraine) Regional AIDS Center: When will they be available to the people who might benefit most from them – people in resource-limited settings, people who so far have struggled to remember to take their pills every day?

For now, Dr. Angel replied, injectables continue to be a treatment only for those who are already doing well while receiving HIV treatment: those with already suppressed viral load, who are good at taking daily pills, and who are being treated at well-resourced clinics.

“There are huge obstacles to overcome if this is ever to be available [in resource-limited settings], and way more obstacles than there are with any oral therapies,” he said. “There’s not been much discussion here about the necessity of cold-chain requirements of pharmacies either centrally or locally, [or] the requirements of additional nurses or health care staff to administer the medication. So you’re looking at a very resource-intensive therapy, which now is fairly restrictive [as to] who will have access to it.”

Dr. Angel reports serving on advisory boards for ViiV Healthcare and Gilead Sciences and has done contract research for ViiV Healthcare, Gilead, and Merck. Dr. Orkin has received research grants, fees as a consultant, travel sponsorship, and speaker fees from ViiV, Merck, and GlaxoSmithKline. Dr. Vasylyev reported no relevant financial relationships.  

A version of this article first appeared on Medscape.com.

Can treatment or removal of high-grade squamous intraepithelial lesions (HSIL) reduce the likelihood of developing anal cancer in people living with HIV (PLHIV)?

“In theory, looking for and treating high-grade disease (like we know works in the cervix) is a potential way to prevent anal cancer in high-risk individuals,” Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the University of California, San Francisco’s Anal Neoplasia Clinic, told this news organization. “But we’ve never had any direct evidence that it worked,” he said.

Initial findings from ANCHOR – the first randomized trial to demonstrate that anal cancer can be prevented in high-risk, HIV-infected patients – promise to change that paradigm and may even portend a new standard of care.

Undoubtedly, this is welcome news for the HIV community, who are not only at increased risk for anal HSIL overall, but among whom anal cancer cases have been rising over the past decade. This is especially true for women who are expected to bear a large portion of overall burden of human papillomavirus (HPV)–associated anal squamous cell carcinoma over the next 10 to 20 years.

In the study, 4,446 PLHIV ages 35 and older with precursor anal HSIL were randomly assigned to topical (imiquimod intra-anally, perianally, or both, or fluorouracil) or ablative (infrared coagulation, hyfrecation/electrocautery) treatment, or active surveillance, and followed every 6 months for 5 years. The study population was broadly representative, including men who have sex with men (MSM), women, transgender people, and historically underrepresented minorities, a factor that reinforces the study’s importance in this specific population.

Because the primary endpoint was reached (that is, to determine if HSIL treatment and removal effectively reduces anal cancer incidence in HIV-infected men and women), the Data Safety Board halted accrual and recommended that participants in the surveillance group be offered treatment moving forward. While the investigators are currently working on publication of the results, the study is ongoing.

Still, the ANCHOR study, which is one of the largest malignancy screening studies conducted in PLHIV, has also highlighted significant challenges in how anal cancer is approached in general.

“Anal cancer has many similarities to cervical cancer, where screening for precancerous lesions and treatment have been shown to substantially reduce morbidity and mortality,” said Joseph Sparano, MD, a medical oncologist specializing in HIV and breast cancer at Icahn School of Medicine at Mount Sinai, New York. Dr. Sparano is chair and principal investigator of the AIDS Malignancy Consortium but was not involved in the ANCHOR study.

But, he explained in an interview, “it’s much more difficult and technically challenging to screen for and evaluate the anal canal histology,” noting that New York is currently the only U.S. state to recommend screening for anal dysplasia with high-resolution anoscopy in HIV-infected men and women.

Availability and access to high-resolution anoscopy is limited, said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute’s Clinical Cancer Research Division and director of the Office of HIV and AIDS Malignancy (which, incidentally, cosponsored ANCHOR).

“There are relatively few people that do this at this time,” he added in an interview, pointing out that among those who do, most are obstetricians/gynecologists.

A bit of digging into ANCHOR’s backstory revealed that this was a point of contention at the study’s onset. While physicians participating in the study received extensive training in high-resolution anoscopy, ob/gyns were the fastest to achieve competency and/or had the most prior experience, namely because of their experience in cervical cancer screening in women.

But initial objections by the American Board of Obstetricians and Gynecologists (which at the time, insisted that its members only treat women and threatened to remove their certification if they participated in the research), almost threw a wrench into the study’s start, according to a report in The New York Times. While rational minds prevailed and the board reversed its earlier statements, lack of ample training in the procedure may signal future barriers to treatment.

Another challenge lies in how study findings might be applicable to other groups outside of the HIV/AIDS population, such as people with other forms of immunosuppression who have HSIL, or even healthy women or men who are at risk as a result of penetrative/nonpenetrative sexual or nonsexual (for example, vaginal discharge to the anus) contact.

Although he was unable to share specifics at this time, Dr. Palefsky said that when they designed the ANCHOR study, they were aware that “merely showing efficacy wouldn’t necessarily be sufficient for establishing a standard of care, where[as] other pieces of information undoubtedly would be considered by entities that make guidelines” (for example, an examination of adverse events, risks/benefits, and factors that influence quality of life).

“With that in mind, we are doing a quality-of-life study and, in fact, have [collaborated on], developed, and validated what I think is the first anal disease-specific, quality of life instrument,” Dr. Palefsky said. “The work is still ongoing because we did not complete enrollment in the study, but we are continuing it as part of the follow up.”

Study investigators have also collected samples for a biorepository of specimens that will hopefully facilitate a better understanding of the molecular events driving progression from precancer to cancer. “A lot of people with HIV have these high-grade lesions,” Dr. Palefsky said. “If we were able to identify who’s at highest risk of all of them, that would be very important, because we prefer not to treat everybody with high-grade disease,” he noted, adding that the “underlying hope is that the biomarkers we find in the setting will also be relevant for other HPV-related cancers,” especially in women.

Dr. Yarchoan concurred. “One of the challenges is going to be to digest this information and see how to use it to potentially address the growing problem of females with HIV,” he said.

Dr. Palefsky, Dr. Sparano, and Dr. Yarchoan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Can treatment or removal of high-grade squamous intraepithelial lesions (HSIL) reduce the likelihood of developing anal cancer in people living with HIV (PLHIV)?

“In theory, looking for and treating high-grade disease (like we know works in the cervix) is a potential way to prevent anal cancer in high-risk individuals,” Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the University of California, San Francisco’s Anal Neoplasia Clinic, told this news organization. “But we’ve never had any direct evidence that it worked,” he said.

Initial findings from ANCHOR – the first randomized trial to demonstrate that anal cancer can be prevented in high-risk, HIV-infected patients – promise to change that paradigm and may even portend a new standard of care.

Undoubtedly, this is welcome news for the HIV community, who are not only at increased risk for anal HSIL overall, but among whom anal cancer cases have been rising over the past decade. This is especially true for women who are expected to bear a large portion of overall burden of human papillomavirus (HPV)–associated anal squamous cell carcinoma over the next 10 to 20 years.

In the study, 4,446 PLHIV ages 35 and older with precursor anal HSIL were randomly assigned to topical (imiquimod intra-anally, perianally, or both, or fluorouracil) or ablative (infrared coagulation, hyfrecation/electrocautery) treatment, or active surveillance, and followed every 6 months for 5 years. The study population was broadly representative, including men who have sex with men (MSM), women, transgender people, and historically underrepresented minorities, a factor that reinforces the study’s importance in this specific population.

Because the primary endpoint was reached (that is, to determine if HSIL treatment and removal effectively reduces anal cancer incidence in HIV-infected men and women), the Data Safety Board halted accrual and recommended that participants in the surveillance group be offered treatment moving forward. While the investigators are currently working on publication of the results, the study is ongoing.

Still, the ANCHOR study, which is one of the largest malignancy screening studies conducted in PLHIV, has also highlighted significant challenges in how anal cancer is approached in general.

“Anal cancer has many similarities to cervical cancer, where screening for precancerous lesions and treatment have been shown to substantially reduce morbidity and mortality,” said Joseph Sparano, MD, a medical oncologist specializing in HIV and breast cancer at Icahn School of Medicine at Mount Sinai, New York. Dr. Sparano is chair and principal investigator of the AIDS Malignancy Consortium but was not involved in the ANCHOR study.

But, he explained in an interview, “it’s much more difficult and technically challenging to screen for and evaluate the anal canal histology,” noting that New York is currently the only U.S. state to recommend screening for anal dysplasia with high-resolution anoscopy in HIV-infected men and women.

Availability and access to high-resolution anoscopy is limited, said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute’s Clinical Cancer Research Division and director of the Office of HIV and AIDS Malignancy (which, incidentally, cosponsored ANCHOR).

“There are relatively few people that do this at this time,” he added in an interview, pointing out that among those who do, most are obstetricians/gynecologists.

A bit of digging into ANCHOR’s backstory revealed that this was a point of contention at the study’s onset. While physicians participating in the study received extensive training in high-resolution anoscopy, ob/gyns were the fastest to achieve competency and/or had the most prior experience, namely because of their experience in cervical cancer screening in women.

But initial objections by the American Board of Obstetricians and Gynecologists (which at the time, insisted that its members only treat women and threatened to remove their certification if they participated in the research), almost threw a wrench into the study’s start, according to a report in The New York Times. While rational minds prevailed and the board reversed its earlier statements, lack of ample training in the procedure may signal future barriers to treatment.

Another challenge lies in how study findings might be applicable to other groups outside of the HIV/AIDS population, such as people with other forms of immunosuppression who have HSIL, or even healthy women or men who are at risk as a result of penetrative/nonpenetrative sexual or nonsexual (for example, vaginal discharge to the anus) contact.

Although he was unable to share specifics at this time, Dr. Palefsky said that when they designed the ANCHOR study, they were aware that “merely showing efficacy wouldn’t necessarily be sufficient for establishing a standard of care, where[as] other pieces of information undoubtedly would be considered by entities that make guidelines” (for example, an examination of adverse events, risks/benefits, and factors that influence quality of life).

“With that in mind, we are doing a quality-of-life study and, in fact, have [collaborated on], developed, and validated what I think is the first anal disease-specific, quality of life instrument,” Dr. Palefsky said. “The work is still ongoing because we did not complete enrollment in the study, but we are continuing it as part of the follow up.”

Study investigators have also collected samples for a biorepository of specimens that will hopefully facilitate a better understanding of the molecular events driving progression from precancer to cancer. “A lot of people with HIV have these high-grade lesions,” Dr. Palefsky said. “If we were able to identify who’s at highest risk of all of them, that would be very important, because we prefer not to treat everybody with high-grade disease,” he noted, adding that the “underlying hope is that the biomarkers we find in the setting will also be relevant for other HPV-related cancers,” especially in women.

Dr. Yarchoan concurred. “One of the challenges is going to be to digest this information and see how to use it to potentially address the growing problem of females with HIV,” he said.

Dr. Palefsky, Dr. Sparano, and Dr. Yarchoan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Can treatment or removal of high-grade squamous intraepithelial lesions (HSIL) reduce the likelihood of developing anal cancer in people living with HIV (PLHIV)?

“In theory, looking for and treating high-grade disease (like we know works in the cervix) is a potential way to prevent anal cancer in high-risk individuals,” Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the University of California, San Francisco’s Anal Neoplasia Clinic, told this news organization. “But we’ve never had any direct evidence that it worked,” he said.

Initial findings from ANCHOR – the first randomized trial to demonstrate that anal cancer can be prevented in high-risk, HIV-infected patients – promise to change that paradigm and may even portend a new standard of care.

Undoubtedly, this is welcome news for the HIV community, who are not only at increased risk for anal HSIL overall, but among whom anal cancer cases have been rising over the past decade. This is especially true for women who are expected to bear a large portion of overall burden of human papillomavirus (HPV)–associated anal squamous cell carcinoma over the next 10 to 20 years.

In the study, 4,446 PLHIV ages 35 and older with precursor anal HSIL were randomly assigned to topical (imiquimod intra-anally, perianally, or both, or fluorouracil) or ablative (infrared coagulation, hyfrecation/electrocautery) treatment, or active surveillance, and followed every 6 months for 5 years. The study population was broadly representative, including men who have sex with men (MSM), women, transgender people, and historically underrepresented minorities, a factor that reinforces the study’s importance in this specific population.

Because the primary endpoint was reached (that is, to determine if HSIL treatment and removal effectively reduces anal cancer incidence in HIV-infected men and women), the Data Safety Board halted accrual and recommended that participants in the surveillance group be offered treatment moving forward. While the investigators are currently working on publication of the results, the study is ongoing.

Still, the ANCHOR study, which is one of the largest malignancy screening studies conducted in PLHIV, has also highlighted significant challenges in how anal cancer is approached in general.

“Anal cancer has many similarities to cervical cancer, where screening for precancerous lesions and treatment have been shown to substantially reduce morbidity and mortality,” said Joseph Sparano, MD, a medical oncologist specializing in HIV and breast cancer at Icahn School of Medicine at Mount Sinai, New York. Dr. Sparano is chair and principal investigator of the AIDS Malignancy Consortium but was not involved in the ANCHOR study.

But, he explained in an interview, “it’s much more difficult and technically challenging to screen for and evaluate the anal canal histology,” noting that New York is currently the only U.S. state to recommend screening for anal dysplasia with high-resolution anoscopy in HIV-infected men and women.

Availability and access to high-resolution anoscopy is limited, said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute’s Clinical Cancer Research Division and director of the Office of HIV and AIDS Malignancy (which, incidentally, cosponsored ANCHOR).

“There are relatively few people that do this at this time,” he added in an interview, pointing out that among those who do, most are obstetricians/gynecologists.

A bit of digging into ANCHOR’s backstory revealed that this was a point of contention at the study’s onset. While physicians participating in the study received extensive training in high-resolution anoscopy, ob/gyns were the fastest to achieve competency and/or had the most prior experience, namely because of their experience in cervical cancer screening in women.

But initial objections by the American Board of Obstetricians and Gynecologists (which at the time, insisted that its members only treat women and threatened to remove their certification if they participated in the research), almost threw a wrench into the study’s start, according to a report in The New York Times. While rational minds prevailed and the board reversed its earlier statements, lack of ample training in the procedure may signal future barriers to treatment.

Another challenge lies in how study findings might be applicable to other groups outside of the HIV/AIDS population, such as people with other forms of immunosuppression who have HSIL, or even healthy women or men who are at risk as a result of penetrative/nonpenetrative sexual or nonsexual (for example, vaginal discharge to the anus) contact.

Although he was unable to share specifics at this time, Dr. Palefsky said that when they designed the ANCHOR study, they were aware that “merely showing efficacy wouldn’t necessarily be sufficient for establishing a standard of care, where[as] other pieces of information undoubtedly would be considered by entities that make guidelines” (for example, an examination of adverse events, risks/benefits, and factors that influence quality of life).

“With that in mind, we are doing a quality-of-life study and, in fact, have [collaborated on], developed, and validated what I think is the first anal disease-specific, quality of life instrument,” Dr. Palefsky said. “The work is still ongoing because we did not complete enrollment in the study, but we are continuing it as part of the follow up.”

Study investigators have also collected samples for a biorepository of specimens that will hopefully facilitate a better understanding of the molecular events driving progression from precancer to cancer. “A lot of people with HIV have these high-grade lesions,” Dr. Palefsky said. “If we were able to identify who’s at highest risk of all of them, that would be very important, because we prefer not to treat everybody with high-grade disease,” he noted, adding that the “underlying hope is that the biomarkers we find in the setting will also be relevant for other HPV-related cancers,” especially in women.

Dr. Yarchoan concurred. “One of the challenges is going to be to digest this information and see how to use it to potentially address the growing problem of females with HIV,” he said.

Dr. Palefsky, Dr. Sparano, and Dr. Yarchoan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration (FDA) has approved an expanded indication of the antiretroviral medication Biktarvy for younger children living with HIV. The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.

Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.

The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.

The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.

“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration (FDA) has approved an expanded indication of the antiretroviral medication Biktarvy for younger children living with HIV. The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.

Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.

The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.

The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.

“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration (FDA) has approved an expanded indication of the antiretroviral medication Biktarvy for younger children living with HIV. The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.

Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.

The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.

The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.

“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”

A version of this article first appeared on Medscape.com.

Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.

That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.

Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
 

Sexual history

The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.

“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”

In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.

When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.

After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:

• History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
• More than 1 sexual partner in the past year.
• New sexual partner within 90 days.
• Reason to believe that a sex partner has had other partners in the past year.
• Exchanging sex for drugs or money within the past year.
• Other factors identified locally, including prevalence of infection in the community.

STI screening guidelines

For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.

For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.

HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.

Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.

Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
 

STI treatment guidelines

For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.

The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.

Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.

For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.

The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.

”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.

The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.

“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.

Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.

“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”

Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.

“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.

Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.

Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.

Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.

Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.

That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.

Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
 

Sexual history

The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.

“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”

In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.

When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.

After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:

• History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
• More than 1 sexual partner in the past year.
• New sexual partner within 90 days.
• Reason to believe that a sex partner has had other partners in the past year.
• Exchanging sex for drugs or money within the past year.
• Other factors identified locally, including prevalence of infection in the community.

STI screening guidelines

For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.

For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.

HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.

Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.

Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
 

STI treatment guidelines

For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.

The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.

Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.

For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.

The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.

”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.

The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.

“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.

Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.

“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”

Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.

“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.

Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.

Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.

Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.

Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.

That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.

Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
 

Sexual history

The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.

“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”

In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.

When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.

After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:

• History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
• More than 1 sexual partner in the past year.
• New sexual partner within 90 days.
• Reason to believe that a sex partner has had other partners in the past year.
• Exchanging sex for drugs or money within the past year.
• Other factors identified locally, including prevalence of infection in the community.

STI screening guidelines

For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.

For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.

HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.

Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.

Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
 

STI treatment guidelines

For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.

The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.

Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.

For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.

The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.

”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.

The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.

“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.

Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.

“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”

Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.

“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.

Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.

Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.

Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.

George Froehle, PA, a primary care clinician at CentraCare in rural St. Cloud, Minn., has been prescribing the HIV prevention pill tenofovir disoproxil fumarate plus emtricitabine since it was marketed by the brand name Truvada and the Food and Drug Administration approved it in 2012. But recently, he’s been having conversations with patients about the new HIV prevention pill, tenofovir alafenamide plus emtricitabine (TAF/FTC, Descovy) as well.

“They may have a friend who has heard that Descovy is newer and safer,” Mr. Froehle said. But that’s not necessarily the case, at least according to lab values. A recent study in the journal Open Forum Infectious Diseases suggests that only between 1 in 10 and 1 in 3 switches to the new formulation of HIV pre-exposure prophylaxis (PrEP) are indicated by lab work – and that nearly half of people receiving a prescription for the new version had lab results actually contraindicating the switch.

This, combined with the lower cost of generic Truvada and the steep cost of Descovy, led study coauthor and HIV PrEP prescriber Douglas Krakower, MD, and colleagues to suggest that the generic version should be standard of care for all people on PrEP unless otherwise indicated.

This just “makes good sense,” Dr. Krakower, assistant professor of medicine at Harvard Medical School, Boston, told this news organization.

“It’s important to ultimately allow for patients and providers to have access to all of the PrEP options so they can choose the best option for each person,” he said. “But our data suggest that strategies to optimize the cost-effectiveness of PrEP prescribing, such as formulary interventions and education for patients and providers, could be beneficial – as long as there is an easy mechanism for patients and providers to override restrictions when there are clinical indications.”

Current PrEP guidelines from the Centers for Disease Control and Prevention don’t list a first-line or second-line treatment for PrEP. But recent guidance issued to insurance companies by the Biden administration specifically grants insurers permission to employ stepped formularies and cost sharing.

“Since the branded version of PrEP is not specified in the [U.S. Preventive Services Task Force] recommendation, plans and issuers may cover a generic version of PrEP without cost sharing and impose cost sharing on an equivalent branded version,” the rule, issued July 19, states. “However, plans and insurers must accommodate any individual for whom a particular PrEP medication [generic or brand name] would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for waiving the otherwise applicable cost-sharing for the brand or nonpreferred brand version.”

Both drugs have been found to be 99% effective in stopping HIV acquisition in people at risk for it. Descovy is approved specifically for gay and bisexual men, transgender women, and anyone having anal sex. Ongoing studies are looking at the effectiveness of Descovy in people having vaginal sex. Generic Truvada has been approved for all people.
 

The biomarkers of switching

To be clear, both medicines are exceedingly safe, said lead author and epidemiologist Julia Marcus, PhD, MPH, associate professor at Harvard Medical School. Side effects have been mild and include nausea and diarrhea in the first month. What lab work tells clinicians is the potential for physiologic changes, but those changes don’t necessarily translate to clinical events.

“When I say harmful, I mean potentially harmful,” she said in an interview. “It’s really based on these incremental changes that maybe, in the long run, could be harmful.”

But she added that there are two types of damage from medicines: “There’s potential physiological damage, but there’s also potential financial damage.” While generic Truvada has a list price as low as $30 a bottle, Descovy has a list price of up to $2,000 a month. And the push for PrEP is growing. Recently, the head of the division of HIV/AIDS at the National Institute of Allergy and Infectious Diseases urged providers to get all their “HIV-negative, at-risk patients on PrEP tomorrow,” in light of the latest HIV vaccine failure.

So Dr. Marcus and team looked at data from the 2892 people who started taking PrEP in the year before the FDA approved Descovy in October 2019. Participants accessed PrEP through Fenway Health, a Boston-area health clinic serving a largely gay, lesbian, bisexual, transgender, and otherwise queer population, and the largest PrEP prescriber in New England. They then tracked which participants switched to Descovy and correlated the switches to lab work and CDC guidance for PrEP.

What they found was that just 11.9% of participants, or 343 people, switched to the newer formulation. That’s lower than the 27.2% who switched in nationally available data, which were released at a recent HIV conference. But when Dr. Krakower and colleagues looked at whether their PrEP prescriptions were appropriate based on the patients’ lab work, the findings were mixed.

On the one hand, they showed that 24 of those 343 people who switched to Descovy had creatinine clearance levels or bone mineral density measurements low enough to make the switch a good option. But that’s just 7% of all people who switched. They then ran a secondary model, in which they broadened the criteria for a switch from strictly those lab values to conditions that might indicate borderline kidney function, which could eventually lead to kidney damage. These included diagnoses of hypertension or diabetes, or borderline creatinine levels between 60 and 70 mL/minute.

“Even when we defined clinical indications as generously as we could, we still saw that only a minority had clinical indications for switching,” said “Most of the switching to TAF/FTC was potentially unnecessary, and some of it may have been harmful for people who had cardiovascular risk factors.”

That’s because although Descovy doesn’t affect renal and bone mineral markers, it does affect cholesterol levels and weight. Aftermarket and FDA data revealed a small but noticeable increase in statin use among people taking the new brand-name PrEP pill. When Marcus and colleagues looked for those biomarkers – total cholesterol greater than200, BMI of 30 or more, LDL cholesterol of more than 160 or HDL cholesterol of less than 40 – 14% of switches fit the criteria for contraindications for Descovy. That’s 10 times the rate of potential harm in switching as there was for those who stayed on the generic Truvada and would have been better served on Descovy. That came in at just 1.4%.

“There may be many reasons why patients or providers might choose to switch that we couldn’t document in our study,” she said. For instance, the newer formulation, Descovy, is a significantly smaller pill than the generic is. Or the perception of novelty might drive some switches.

“But I think we need qualitative work to understand how these decisions are being made,” she said in an interview. “It will be important to follow these patients to see what happens in terms of clinical outcomes.”

For his part, Mr. Froehle found the study intriguing. It reflects his own thinking around the value of the newer formulation. He also prescribes for people living with HIV. For them, the benefit of the new formulation of tenofovir present in Descovy has clear clinical relevance. After all, people living with HIV can be on their drug regimens for decades.

But people on PrEP aren’t likely to be on the pills as long, and so the real benefit of the newer, more expensive formulation is less clear. And he added that he’s already getting “pushback” from some insurance companies on the name-brand version, with companies asking for proof via lab values that a person has a history of kidney impairment or bone mineral density loss.

“It doesn’t happen a ton,” he said. “But it’s starting to happen, and normally it kind of builds from there.”

So when a patient comes in and asks specifically for Descovy, he usually will talk to them about it.

“If it’s what the patient wants and insurance covers it and it’s not unsafe for them to be on it, there might not be a reason to not prescribe Descovy,” said Mr. Froehle, who served as a sub-principal investigator for the DISCOVER clinical trial that showed the new PrEP was as effective as Truvada. “But now with Truvada being generic, we will talk about Truvada as being something we start up front because it may have a lower cost and it’s cheaper to the system. Then we can always switch to Descovy as needed.”

This study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Marcus reported receiving fees from Kaiser Permanente Northern California on a research grant from Gilead Sciences. Dr. Krakower reported having conducted research that was funded by Gilead Sciences and Merck, as well as honoraria for medical education content and presentations for Medscape Medical News, MED-IQ, and DKBMed and royalties from work conducted by UpToDate. Mr. Froehle reported receiving fees from Gilead Sciences in connection with a Gilead advisory board.

A version of this article first appeared on Medscape.com.

George Froehle, PA, a primary care clinician at CentraCare in rural St. Cloud, Minn., has been prescribing the HIV prevention pill tenofovir disoproxil fumarate plus emtricitabine since it was marketed by the brand name Truvada and the Food and Drug Administration approved it in 2012. But recently, he’s been having conversations with patients about the new HIV prevention pill, tenofovir alafenamide plus emtricitabine (TAF/FTC, Descovy) as well.

“They may have a friend who has heard that Descovy is newer and safer,” Mr. Froehle said. But that’s not necessarily the case, at least according to lab values. A recent study in the journal Open Forum Infectious Diseases suggests that only between 1 in 10 and 1 in 3 switches to the new formulation of HIV pre-exposure prophylaxis (PrEP) are indicated by lab work – and that nearly half of people receiving a prescription for the new version had lab results actually contraindicating the switch.

This, combined with the lower cost of generic Truvada and the steep cost of Descovy, led study coauthor and HIV PrEP prescriber Douglas Krakower, MD, and colleagues to suggest that the generic version should be standard of care for all people on PrEP unless otherwise indicated.

This just “makes good sense,” Dr. Krakower, assistant professor of medicine at Harvard Medical School, Boston, told this news organization.

“It’s important to ultimately allow for patients and providers to have access to all of the PrEP options so they can choose the best option for each person,” he said. “But our data suggest that strategies to optimize the cost-effectiveness of PrEP prescribing, such as formulary interventions and education for patients and providers, could be beneficial – as long as there is an easy mechanism for patients and providers to override restrictions when there are clinical indications.”

Current PrEP guidelines from the Centers for Disease Control and Prevention don’t list a first-line or second-line treatment for PrEP. But recent guidance issued to insurance companies by the Biden administration specifically grants insurers permission to employ stepped formularies and cost sharing.

“Since the branded version of PrEP is not specified in the [U.S. Preventive Services Task Force] recommendation, plans and issuers may cover a generic version of PrEP without cost sharing and impose cost sharing on an equivalent branded version,” the rule, issued July 19, states. “However, plans and insurers must accommodate any individual for whom a particular PrEP medication [generic or brand name] would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for waiving the otherwise applicable cost-sharing for the brand or nonpreferred brand version.”

Both drugs have been found to be 99% effective in stopping HIV acquisition in people at risk for it. Descovy is approved specifically for gay and bisexual men, transgender women, and anyone having anal sex. Ongoing studies are looking at the effectiveness of Descovy in people having vaginal sex. Generic Truvada has been approved for all people.
 

The biomarkers of switching

To be clear, both medicines are exceedingly safe, said lead author and epidemiologist Julia Marcus, PhD, MPH, associate professor at Harvard Medical School. Side effects have been mild and include nausea and diarrhea in the first month. What lab work tells clinicians is the potential for physiologic changes, but those changes don’t necessarily translate to clinical events.

“When I say harmful, I mean potentially harmful,” she said in an interview. “It’s really based on these incremental changes that maybe, in the long run, could be harmful.”

But she added that there are two types of damage from medicines: “There’s potential physiological damage, but there’s also potential financial damage.” While generic Truvada has a list price as low as $30 a bottle, Descovy has a list price of up to $2,000 a month. And the push for PrEP is growing. Recently, the head of the division of HIV/AIDS at the National Institute of Allergy and Infectious Diseases urged providers to get all their “HIV-negative, at-risk patients on PrEP tomorrow,” in light of the latest HIV vaccine failure.

So Dr. Marcus and team looked at data from the 2892 people who started taking PrEP in the year before the FDA approved Descovy in October 2019. Participants accessed PrEP through Fenway Health, a Boston-area health clinic serving a largely gay, lesbian, bisexual, transgender, and otherwise queer population, and the largest PrEP prescriber in New England. They then tracked which participants switched to Descovy and correlated the switches to lab work and CDC guidance for PrEP.

What they found was that just 11.9% of participants, or 343 people, switched to the newer formulation. That’s lower than the 27.2% who switched in nationally available data, which were released at a recent HIV conference. But when Dr. Krakower and colleagues looked at whether their PrEP prescriptions were appropriate based on the patients’ lab work, the findings were mixed.

On the one hand, they showed that 24 of those 343 people who switched to Descovy had creatinine clearance levels or bone mineral density measurements low enough to make the switch a good option. But that’s just 7% of all people who switched. They then ran a secondary model, in which they broadened the criteria for a switch from strictly those lab values to conditions that might indicate borderline kidney function, which could eventually lead to kidney damage. These included diagnoses of hypertension or diabetes, or borderline creatinine levels between 60 and 70 mL/minute.

“Even when we defined clinical indications as generously as we could, we still saw that only a minority had clinical indications for switching,” said “Most of the switching to TAF/FTC was potentially unnecessary, and some of it may have been harmful for people who had cardiovascular risk factors.”

That’s because although Descovy doesn’t affect renal and bone mineral markers, it does affect cholesterol levels and weight. Aftermarket and FDA data revealed a small but noticeable increase in statin use among people taking the new brand-name PrEP pill. When Marcus and colleagues looked for those biomarkers – total cholesterol greater than200, BMI of 30 or more, LDL cholesterol of more than 160 or HDL cholesterol of less than 40 – 14% of switches fit the criteria for contraindications for Descovy. That’s 10 times the rate of potential harm in switching as there was for those who stayed on the generic Truvada and would have been better served on Descovy. That came in at just 1.4%.

“There may be many reasons why patients or providers might choose to switch that we couldn’t document in our study,” she said. For instance, the newer formulation, Descovy, is a significantly smaller pill than the generic is. Or the perception of novelty might drive some switches.

“But I think we need qualitative work to understand how these decisions are being made,” she said in an interview. “It will be important to follow these patients to see what happens in terms of clinical outcomes.”

For his part, Mr. Froehle found the study intriguing. It reflects his own thinking around the value of the newer formulation. He also prescribes for people living with HIV. For them, the benefit of the new formulation of tenofovir present in Descovy has clear clinical relevance. After all, people living with HIV can be on their drug regimens for decades.

But people on PrEP aren’t likely to be on the pills as long, and so the real benefit of the newer, more expensive formulation is less clear. And he added that he’s already getting “pushback” from some insurance companies on the name-brand version, with companies asking for proof via lab values that a person has a history of kidney impairment or bone mineral density loss.

“It doesn’t happen a ton,” he said. “But it’s starting to happen, and normally it kind of builds from there.”

So when a patient comes in and asks specifically for Descovy, he usually will talk to them about it.

“If it’s what the patient wants and insurance covers it and it’s not unsafe for them to be on it, there might not be a reason to not prescribe Descovy,” said Mr. Froehle, who served as a sub-principal investigator for the DISCOVER clinical trial that showed the new PrEP was as effective as Truvada. “But now with Truvada being generic, we will talk about Truvada as being something we start up front because it may have a lower cost and it’s cheaper to the system. Then we can always switch to Descovy as needed.”

This study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Marcus reported receiving fees from Kaiser Permanente Northern California on a research grant from Gilead Sciences. Dr. Krakower reported having conducted research that was funded by Gilead Sciences and Merck, as well as honoraria for medical education content and presentations for Medscape Medical News, MED-IQ, and DKBMed and royalties from work conducted by UpToDate. Mr. Froehle reported receiving fees from Gilead Sciences in connection with a Gilead advisory board.

A version of this article first appeared on Medscape.com.

George Froehle, PA, a primary care clinician at CentraCare in rural St. Cloud, Minn., has been prescribing the HIV prevention pill tenofovir disoproxil fumarate plus emtricitabine since it was marketed by the brand name Truvada and the Food and Drug Administration approved it in 2012. But recently, he’s been having conversations with patients about the new HIV prevention pill, tenofovir alafenamide plus emtricitabine (TAF/FTC, Descovy) as well.

“They may have a friend who has heard that Descovy is newer and safer,” Mr. Froehle said. But that’s not necessarily the case, at least according to lab values. A recent study in the journal Open Forum Infectious Diseases suggests that only between 1 in 10 and 1 in 3 switches to the new formulation of HIV pre-exposure prophylaxis (PrEP) are indicated by lab work – and that nearly half of people receiving a prescription for the new version had lab results actually contraindicating the switch.

This, combined with the lower cost of generic Truvada and the steep cost of Descovy, led study coauthor and HIV PrEP prescriber Douglas Krakower, MD, and colleagues to suggest that the generic version should be standard of care for all people on PrEP unless otherwise indicated.

This just “makes good sense,” Dr. Krakower, assistant professor of medicine at Harvard Medical School, Boston, told this news organization.

“It’s important to ultimately allow for patients and providers to have access to all of the PrEP options so they can choose the best option for each person,” he said. “But our data suggest that strategies to optimize the cost-effectiveness of PrEP prescribing, such as formulary interventions and education for patients and providers, could be beneficial – as long as there is an easy mechanism for patients and providers to override restrictions when there are clinical indications.”

Current PrEP guidelines from the Centers for Disease Control and Prevention don’t list a first-line or second-line treatment for PrEP. But recent guidance issued to insurance companies by the Biden administration specifically grants insurers permission to employ stepped formularies and cost sharing.

“Since the branded version of PrEP is not specified in the [U.S. Preventive Services Task Force] recommendation, plans and issuers may cover a generic version of PrEP without cost sharing and impose cost sharing on an equivalent branded version,” the rule, issued July 19, states. “However, plans and insurers must accommodate any individual for whom a particular PrEP medication [generic or brand name] would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for waiving the otherwise applicable cost-sharing for the brand or nonpreferred brand version.”

Both drugs have been found to be 99% effective in stopping HIV acquisition in people at risk for it. Descovy is approved specifically for gay and bisexual men, transgender women, and anyone having anal sex. Ongoing studies are looking at the effectiveness of Descovy in people having vaginal sex. Generic Truvada has been approved for all people.
 

The biomarkers of switching

To be clear, both medicines are exceedingly safe, said lead author and epidemiologist Julia Marcus, PhD, MPH, associate professor at Harvard Medical School. Side effects have been mild and include nausea and diarrhea in the first month. What lab work tells clinicians is the potential for physiologic changes, but those changes don’t necessarily translate to clinical events.

“When I say harmful, I mean potentially harmful,” she said in an interview. “It’s really based on these incremental changes that maybe, in the long run, could be harmful.”

But she added that there are two types of damage from medicines: “There’s potential physiological damage, but there’s also potential financial damage.” While generic Truvada has a list price as low as $30 a bottle, Descovy has a list price of up to $2,000 a month. And the push for PrEP is growing. Recently, the head of the division of HIV/AIDS at the National Institute of Allergy and Infectious Diseases urged providers to get all their “HIV-negative, at-risk patients on PrEP tomorrow,” in light of the latest HIV vaccine failure.

So Dr. Marcus and team looked at data from the 2892 people who started taking PrEP in the year before the FDA approved Descovy in October 2019. Participants accessed PrEP through Fenway Health, a Boston-area health clinic serving a largely gay, lesbian, bisexual, transgender, and otherwise queer population, and the largest PrEP prescriber in New England. They then tracked which participants switched to Descovy and correlated the switches to lab work and CDC guidance for PrEP.

What they found was that just 11.9% of participants, or 343 people, switched to the newer formulation. That’s lower than the 27.2% who switched in nationally available data, which were released at a recent HIV conference. But when Dr. Krakower and colleagues looked at whether their PrEP prescriptions were appropriate based on the patients’ lab work, the findings were mixed.

On the one hand, they showed that 24 of those 343 people who switched to Descovy had creatinine clearance levels or bone mineral density measurements low enough to make the switch a good option. But that’s just 7% of all people who switched. They then ran a secondary model, in which they broadened the criteria for a switch from strictly those lab values to conditions that might indicate borderline kidney function, which could eventually lead to kidney damage. These included diagnoses of hypertension or diabetes, or borderline creatinine levels between 60 and 70 mL/minute.

“Even when we defined clinical indications as generously as we could, we still saw that only a minority had clinical indications for switching,” said “Most of the switching to TAF/FTC was potentially unnecessary, and some of it may have been harmful for people who had cardiovascular risk factors.”

That’s because although Descovy doesn’t affect renal and bone mineral markers, it does affect cholesterol levels and weight. Aftermarket and FDA data revealed a small but noticeable increase in statin use among people taking the new brand-name PrEP pill. When Marcus and colleagues looked for those biomarkers – total cholesterol greater than200, BMI of 30 or more, LDL cholesterol of more than 160 or HDL cholesterol of less than 40 – 14% of switches fit the criteria for contraindications for Descovy. That’s 10 times the rate of potential harm in switching as there was for those who stayed on the generic Truvada and would have been better served on Descovy. That came in at just 1.4%.

“There may be many reasons why patients or providers might choose to switch that we couldn’t document in our study,” she said. For instance, the newer formulation, Descovy, is a significantly smaller pill than the generic is. Or the perception of novelty might drive some switches.

“But I think we need qualitative work to understand how these decisions are being made,” she said in an interview. “It will be important to follow these patients to see what happens in terms of clinical outcomes.”

For his part, Mr. Froehle found the study intriguing. It reflects his own thinking around the value of the newer formulation. He also prescribes for people living with HIV. For them, the benefit of the new formulation of tenofovir present in Descovy has clear clinical relevance. After all, people living with HIV can be on their drug regimens for decades.

But people on PrEP aren’t likely to be on the pills as long, and so the real benefit of the newer, more expensive formulation is less clear. And he added that he’s already getting “pushback” from some insurance companies on the name-brand version, with companies asking for proof via lab values that a person has a history of kidney impairment or bone mineral density loss.

“It doesn’t happen a ton,” he said. “But it’s starting to happen, and normally it kind of builds from there.”

So when a patient comes in and asks specifically for Descovy, he usually will talk to them about it.

“If it’s what the patient wants and insurance covers it and it’s not unsafe for them to be on it, there might not be a reason to not prescribe Descovy,” said Mr. Froehle, who served as a sub-principal investigator for the DISCOVER clinical trial that showed the new PrEP was as effective as Truvada. “But now with Truvada being generic, we will talk about Truvada as being something we start up front because it may have a lower cost and it’s cheaper to the system. Then we can always switch to Descovy as needed.”

This study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Marcus reported receiving fees from Kaiser Permanente Northern California on a research grant from Gilead Sciences. Dr. Krakower reported having conducted research that was funded by Gilead Sciences and Merck, as well as honoraria for medical education content and presentations for Medscape Medical News, MED-IQ, and DKBMed and royalties from work conducted by UpToDate. Mr. Froehle reported receiving fees from Gilead Sciences in connection with a Gilead advisory board.

A version of this article first appeared on Medscape.com.