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Rising viral load on dolutegravir? Investigators try fix before switch
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
AT IAS 2023
Results from halted islatravir antiretroviral trial presented
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Injecting long-acting antiretrovirals into clinic care
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
FROM IAS 2023
UNAIDS targets: Progress reported, but ‘HIV is far from over’
BRISBANE, AUSTRALIA – The year was 1987 and the Grim Reaper (a personification of death), holding a large scythe, rolled a 10-pin bowling ball through a dark, foggy place. In the advertisement on television, the cloaked skeleton aimed the bowling ball at the other end of a lane where a group of people stood in place of pins.
Who would fall next?
In the 1980s, cases of HIV were rising in the community and people in Australia and elsewhere were dying of AIDS. The Australian government opted to use mainstream media to deliver a blunt message through advertising to raise awareness about the health risk and how to manage HIV in the community.
But the campaign also contributed to stigma for those living with the disease and especially those in the gay community who felt ostracized by rising public concern.
In the inner city of Sydney, a few thousand people died of AIDS, Andrew Grulich, MD, PhD, from the Kirby Institute at the University of New South Wales, Sydney, and involved in tracking cases, said in an interview. “Sydney was devastated by AIDS, it was truly devastated.”
HIV and AIDS quickly became an even more severe problem for several countries around Australia in Thailand, Papua New Guinea, and beyond. After HIV was first reported in Thailand in 1984, the region had the highest prevalence of HIV in Southeast Asia. Through the 1990s in Papua New Guinea, HIV prevalence rose steeply as well.
By 2010, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set a target of a 90% reduction in HIV incidence, a 90% reduction in AIDS deaths by 2030, and 95% of people living with HIV and AIDS being aware of their status, on treatment, and having an undetectable viral load.
Since then, significant progress has been made globally with 86% of people knowing their HIV status. However, new infections persist at a rate that has not dropped as fast as possible.
New infections
According to the latest UNAIDS report, regions of North America and western and central Europe showed a 23% decline in new infections from 2010 to 2022, below the target 90% reduction.
Some regions of the United States have seen significant declines in new HIV infections. San Francisco has a 67% drop in new diagnoses. And now, along with the District of Columbia, the four states with the highest HIV rates are New York, Maryland, Georgia, and Florida.
Several countries in eastern and southern Africa are close to achieving their target HIV reduction of 90%.
Mitchell Warren, executive director of AVAC for global health advocacy, access, and equity, said that many of the low- and middle-income countries that are on track to achieve targets are able to do so because of support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
“That foreign development assistance is transforming the AIDS response in a number of African countries, and yet at home, in various states and municipalities, not only are we not reaching that effort, we don’t even use those targets,” Mr. Warren pointed out.
“We might see municipalities that are performing well, but at a national level it’s frankly a disgrace by comparison, because we know what’s possible,” Mr. Warren said.
Lowering cases
Today, in the inner city of Sydney, new HIV diagnoses have plummeted by 88%, which puts the area on track to achieve the 90% UNAIDS target ahead of schedule.
Dr. Grulich and his team at the Kirby Institute are tracking new diagnoses by postal code and reported their encouraging findings here this week at the International AIDS Society Conference on HIV Science.
“This 88% decline is happening in an area where, in the ’80s and ’90s, a few thousand people died of AIDS,” Dr. Grulich told this news organization. “It feels close to miraculous.”
Dr. Grulich attributes some of the success to long-term government leadership that for the most part has been apolitical. HIV has been perceived by the public as an important health issue to be addressed. “We’ve never had a political contest over it,” he added. “We have politicians who are committed to evidence-based policy.”
In inner city Sydney, HIV prevention campaigns are a visible part of community life, Dr. Grulich explained. At public events, it is discussed; at bus stops, posters are on display; and passing trains have messages plastered to the side of them.
That community effort has consistently received government funding for years – albeit linked to key performance indicators – but it has enabled a high level of communication among government, community, clinicians, and researchers.
Another advantage is Australia’s universal health coverage, said Sharon Lewin, PhD, president of the International AIDS Society and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne. “One very clear difference for Australia is a health system that provides free medication and free prevention,” she said. “You can’t underestimate the impact that has on public health.”
Globally, significant progress has been made toward the UN’s 95-95-95 targets, with 86% of people with HIV now knowing their status, 88% of those being on treatment, and 93% of those having an undetectable viral load, “for a total of 75% of all people living with HIV worldwide with undetectable viral load,” Dr. Grulich pointed out.
But Dr. Lewin cautioned that now is not the time to take our eye off the ball, especially with respect to the 39 million or so people living with HIV globally, all of whom need lifelong treatment and care to manage their disease. “We also need to be aware that if we relax the investment, and people stop their treatment, transmission occurs again,” Dr. Lewin warned. “Despite the great news of potentially getting close to eliminating HIV transmission in Australia, HIV is far from over.”
A version of this article first appeared on Medscape.com.
BRISBANE, AUSTRALIA – The year was 1987 and the Grim Reaper (a personification of death), holding a large scythe, rolled a 10-pin bowling ball through a dark, foggy place. In the advertisement on television, the cloaked skeleton aimed the bowling ball at the other end of a lane where a group of people stood in place of pins.
Who would fall next?
In the 1980s, cases of HIV were rising in the community and people in Australia and elsewhere were dying of AIDS. The Australian government opted to use mainstream media to deliver a blunt message through advertising to raise awareness about the health risk and how to manage HIV in the community.
But the campaign also contributed to stigma for those living with the disease and especially those in the gay community who felt ostracized by rising public concern.
In the inner city of Sydney, a few thousand people died of AIDS, Andrew Grulich, MD, PhD, from the Kirby Institute at the University of New South Wales, Sydney, and involved in tracking cases, said in an interview. “Sydney was devastated by AIDS, it was truly devastated.”
HIV and AIDS quickly became an even more severe problem for several countries around Australia in Thailand, Papua New Guinea, and beyond. After HIV was first reported in Thailand in 1984, the region had the highest prevalence of HIV in Southeast Asia. Through the 1990s in Papua New Guinea, HIV prevalence rose steeply as well.
By 2010, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set a target of a 90% reduction in HIV incidence, a 90% reduction in AIDS deaths by 2030, and 95% of people living with HIV and AIDS being aware of their status, on treatment, and having an undetectable viral load.
Since then, significant progress has been made globally with 86% of people knowing their HIV status. However, new infections persist at a rate that has not dropped as fast as possible.
New infections
According to the latest UNAIDS report, regions of North America and western and central Europe showed a 23% decline in new infections from 2010 to 2022, below the target 90% reduction.
Some regions of the United States have seen significant declines in new HIV infections. San Francisco has a 67% drop in new diagnoses. And now, along with the District of Columbia, the four states with the highest HIV rates are New York, Maryland, Georgia, and Florida.
Several countries in eastern and southern Africa are close to achieving their target HIV reduction of 90%.
Mitchell Warren, executive director of AVAC for global health advocacy, access, and equity, said that many of the low- and middle-income countries that are on track to achieve targets are able to do so because of support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
“That foreign development assistance is transforming the AIDS response in a number of African countries, and yet at home, in various states and municipalities, not only are we not reaching that effort, we don’t even use those targets,” Mr. Warren pointed out.
“We might see municipalities that are performing well, but at a national level it’s frankly a disgrace by comparison, because we know what’s possible,” Mr. Warren said.
Lowering cases
Today, in the inner city of Sydney, new HIV diagnoses have plummeted by 88%, which puts the area on track to achieve the 90% UNAIDS target ahead of schedule.
Dr. Grulich and his team at the Kirby Institute are tracking new diagnoses by postal code and reported their encouraging findings here this week at the International AIDS Society Conference on HIV Science.
“This 88% decline is happening in an area where, in the ’80s and ’90s, a few thousand people died of AIDS,” Dr. Grulich told this news organization. “It feels close to miraculous.”
Dr. Grulich attributes some of the success to long-term government leadership that for the most part has been apolitical. HIV has been perceived by the public as an important health issue to be addressed. “We’ve never had a political contest over it,” he added. “We have politicians who are committed to evidence-based policy.”
In inner city Sydney, HIV prevention campaigns are a visible part of community life, Dr. Grulich explained. At public events, it is discussed; at bus stops, posters are on display; and passing trains have messages plastered to the side of them.
That community effort has consistently received government funding for years – albeit linked to key performance indicators – but it has enabled a high level of communication among government, community, clinicians, and researchers.
Another advantage is Australia’s universal health coverage, said Sharon Lewin, PhD, president of the International AIDS Society and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne. “One very clear difference for Australia is a health system that provides free medication and free prevention,” she said. “You can’t underestimate the impact that has on public health.”
Globally, significant progress has been made toward the UN’s 95-95-95 targets, with 86% of people with HIV now knowing their status, 88% of those being on treatment, and 93% of those having an undetectable viral load, “for a total of 75% of all people living with HIV worldwide with undetectable viral load,” Dr. Grulich pointed out.
But Dr. Lewin cautioned that now is not the time to take our eye off the ball, especially with respect to the 39 million or so people living with HIV globally, all of whom need lifelong treatment and care to manage their disease. “We also need to be aware that if we relax the investment, and people stop their treatment, transmission occurs again,” Dr. Lewin warned. “Despite the great news of potentially getting close to eliminating HIV transmission in Australia, HIV is far from over.”
A version of this article first appeared on Medscape.com.
BRISBANE, AUSTRALIA – The year was 1987 and the Grim Reaper (a personification of death), holding a large scythe, rolled a 10-pin bowling ball through a dark, foggy place. In the advertisement on television, the cloaked skeleton aimed the bowling ball at the other end of a lane where a group of people stood in place of pins.
Who would fall next?
In the 1980s, cases of HIV were rising in the community and people in Australia and elsewhere were dying of AIDS. The Australian government opted to use mainstream media to deliver a blunt message through advertising to raise awareness about the health risk and how to manage HIV in the community.
But the campaign also contributed to stigma for those living with the disease and especially those in the gay community who felt ostracized by rising public concern.
In the inner city of Sydney, a few thousand people died of AIDS, Andrew Grulich, MD, PhD, from the Kirby Institute at the University of New South Wales, Sydney, and involved in tracking cases, said in an interview. “Sydney was devastated by AIDS, it was truly devastated.”
HIV and AIDS quickly became an even more severe problem for several countries around Australia in Thailand, Papua New Guinea, and beyond. After HIV was first reported in Thailand in 1984, the region had the highest prevalence of HIV in Southeast Asia. Through the 1990s in Papua New Guinea, HIV prevalence rose steeply as well.
By 2010, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set a target of a 90% reduction in HIV incidence, a 90% reduction in AIDS deaths by 2030, and 95% of people living with HIV and AIDS being aware of their status, on treatment, and having an undetectable viral load.
Since then, significant progress has been made globally with 86% of people knowing their HIV status. However, new infections persist at a rate that has not dropped as fast as possible.
New infections
According to the latest UNAIDS report, regions of North America and western and central Europe showed a 23% decline in new infections from 2010 to 2022, below the target 90% reduction.
Some regions of the United States have seen significant declines in new HIV infections. San Francisco has a 67% drop in new diagnoses. And now, along with the District of Columbia, the four states with the highest HIV rates are New York, Maryland, Georgia, and Florida.
Several countries in eastern and southern Africa are close to achieving their target HIV reduction of 90%.
Mitchell Warren, executive director of AVAC for global health advocacy, access, and equity, said that many of the low- and middle-income countries that are on track to achieve targets are able to do so because of support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
“That foreign development assistance is transforming the AIDS response in a number of African countries, and yet at home, in various states and municipalities, not only are we not reaching that effort, we don’t even use those targets,” Mr. Warren pointed out.
“We might see municipalities that are performing well, but at a national level it’s frankly a disgrace by comparison, because we know what’s possible,” Mr. Warren said.
Lowering cases
Today, in the inner city of Sydney, new HIV diagnoses have plummeted by 88%, which puts the area on track to achieve the 90% UNAIDS target ahead of schedule.
Dr. Grulich and his team at the Kirby Institute are tracking new diagnoses by postal code and reported their encouraging findings here this week at the International AIDS Society Conference on HIV Science.
“This 88% decline is happening in an area where, in the ’80s and ’90s, a few thousand people died of AIDS,” Dr. Grulich told this news organization. “It feels close to miraculous.”
Dr. Grulich attributes some of the success to long-term government leadership that for the most part has been apolitical. HIV has been perceived by the public as an important health issue to be addressed. “We’ve never had a political contest over it,” he added. “We have politicians who are committed to evidence-based policy.”
In inner city Sydney, HIV prevention campaigns are a visible part of community life, Dr. Grulich explained. At public events, it is discussed; at bus stops, posters are on display; and passing trains have messages plastered to the side of them.
That community effort has consistently received government funding for years – albeit linked to key performance indicators – but it has enabled a high level of communication among government, community, clinicians, and researchers.
Another advantage is Australia’s universal health coverage, said Sharon Lewin, PhD, president of the International AIDS Society and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne. “One very clear difference for Australia is a health system that provides free medication and free prevention,” she said. “You can’t underestimate the impact that has on public health.”
Globally, significant progress has been made toward the UN’s 95-95-95 targets, with 86% of people with HIV now knowing their status, 88% of those being on treatment, and 93% of those having an undetectable viral load, “for a total of 75% of all people living with HIV worldwide with undetectable viral load,” Dr. Grulich pointed out.
But Dr. Lewin cautioned that now is not the time to take our eye off the ball, especially with respect to the 39 million or so people living with HIV globally, all of whom need lifelong treatment and care to manage their disease. “We also need to be aware that if we relax the investment, and people stop their treatment, transmission occurs again,” Dr. Lewin warned. “Despite the great news of potentially getting close to eliminating HIV transmission in Australia, HIV is far from over.”
A version of this article first appeared on Medscape.com.
Low HIV levels linked to ‘almost zero’ risk of sexual transmission
BRISBANE, AUSTRALIA – from the World Health Organization.
The announcement was made concurrently with the publication of definitive new research in The Lancet. The findings were presented virtually at the International AIDS Society conference on HIV Science.
The WHO estimates that 76% of the 39 million people worldwide living with HIV take antiretroviral therapy (ART).
“Antiretroviral therapy continues to transform the lives of people living with HIV,” a WHO news release stated. “People living with HIV who are diagnosed and treated early, and take their medication as prescribed, can expect to have the same health and life expectancy as their HIV-negative counterparts.”
The Lancet study showed that people who have a viral load of less than 1,000 copies per milliliter of blood have a tiny chance of transmitting the virus to sexual partners. Of 320 cases of transmission reviewed during the study, only 2 transmissions involved a partner with a load below that threshold. Those cases may have been affected by viral loads rising between the time of testing and transmission. The previous guideline for zero risk of transmission was 200 copies per milliliter.
People living with HIV who do not take ART can have viral loads ranging from 30,000 to more than 500,000 copies per milliliter, according a summary of the study distributed by The Lancet to the media.
The new findings do not apply to the transmission of HIV from mother to child, including during pregnancy, childbirth, and breastfeeding.
“The ultimate goal of antiretroviral therapy for people living with HIV is to maintain undetectable viral loads, which will improve their own health and prevent transmission to their sexual partners and children,” said researcher Lara Vojnov, PhD, diagnostics advisor to the WHO Department of Global HIV, Hepatitis and STI Programmes, in a statement. “But these new findings are also significant as they indicate that the risk of sexual transmission of HIV at low viral loads is almost zero. This provides a powerful opportunity to help destigmatize HIV, promote the benefits of adhering to antiretroviral therapy, and support people living with HIV.”
A version of this article first appeared on WebMD.com.
BRISBANE, AUSTRALIA – from the World Health Organization.
The announcement was made concurrently with the publication of definitive new research in The Lancet. The findings were presented virtually at the International AIDS Society conference on HIV Science.
The WHO estimates that 76% of the 39 million people worldwide living with HIV take antiretroviral therapy (ART).
“Antiretroviral therapy continues to transform the lives of people living with HIV,” a WHO news release stated. “People living with HIV who are diagnosed and treated early, and take their medication as prescribed, can expect to have the same health and life expectancy as their HIV-negative counterparts.”
The Lancet study showed that people who have a viral load of less than 1,000 copies per milliliter of blood have a tiny chance of transmitting the virus to sexual partners. Of 320 cases of transmission reviewed during the study, only 2 transmissions involved a partner with a load below that threshold. Those cases may have been affected by viral loads rising between the time of testing and transmission. The previous guideline for zero risk of transmission was 200 copies per milliliter.
People living with HIV who do not take ART can have viral loads ranging from 30,000 to more than 500,000 copies per milliliter, according a summary of the study distributed by The Lancet to the media.
The new findings do not apply to the transmission of HIV from mother to child, including during pregnancy, childbirth, and breastfeeding.
“The ultimate goal of antiretroviral therapy for people living with HIV is to maintain undetectable viral loads, which will improve their own health and prevent transmission to their sexual partners and children,” said researcher Lara Vojnov, PhD, diagnostics advisor to the WHO Department of Global HIV, Hepatitis and STI Programmes, in a statement. “But these new findings are also significant as they indicate that the risk of sexual transmission of HIV at low viral loads is almost zero. This provides a powerful opportunity to help destigmatize HIV, promote the benefits of adhering to antiretroviral therapy, and support people living with HIV.”
A version of this article first appeared on WebMD.com.
BRISBANE, AUSTRALIA – from the World Health Organization.
The announcement was made concurrently with the publication of definitive new research in The Lancet. The findings were presented virtually at the International AIDS Society conference on HIV Science.
The WHO estimates that 76% of the 39 million people worldwide living with HIV take antiretroviral therapy (ART).
“Antiretroviral therapy continues to transform the lives of people living with HIV,” a WHO news release stated. “People living with HIV who are diagnosed and treated early, and take their medication as prescribed, can expect to have the same health and life expectancy as their HIV-negative counterparts.”
The Lancet study showed that people who have a viral load of less than 1,000 copies per milliliter of blood have a tiny chance of transmitting the virus to sexual partners. Of 320 cases of transmission reviewed during the study, only 2 transmissions involved a partner with a load below that threshold. Those cases may have been affected by viral loads rising between the time of testing and transmission. The previous guideline for zero risk of transmission was 200 copies per milliliter.
People living with HIV who do not take ART can have viral loads ranging from 30,000 to more than 500,000 copies per milliliter, according a summary of the study distributed by The Lancet to the media.
The new findings do not apply to the transmission of HIV from mother to child, including during pregnancy, childbirth, and breastfeeding.
“The ultimate goal of antiretroviral therapy for people living with HIV is to maintain undetectable viral loads, which will improve their own health and prevent transmission to their sexual partners and children,” said researcher Lara Vojnov, PhD, diagnostics advisor to the WHO Department of Global HIV, Hepatitis and STI Programmes, in a statement. “But these new findings are also significant as they indicate that the risk of sexual transmission of HIV at low viral loads is almost zero. This provides a powerful opportunity to help destigmatize HIV, promote the benefits of adhering to antiretroviral therapy, and support people living with HIV.”
A version of this article first appeared on WebMD.com.
AT IAS 2023
Daily statin cuts cardiovascular risk in HIV
BRISBANE, AUSTRALIA – that show pitavastatin therapy is associated with a significantly lower risk of cardiovascular events than placebo.
“There was a significant 35% lower risk of major adverse cardiovascular events after a median follow-up of 5.1 years “ said Steven Grinspoon, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, who presented the final analysis of data from the REPRIEVE trial at the International AIDS Society Conference on HIV Science.
The results were simultaneously published in the New England Journal of Medicine. The primary endpoint of major adverse cardiovascular events included a composite of outcomes that included cardiovascular death, stroke, myocardial infarction, hospitalization for unstable angina, and transient ischemic attack among those treated with pitavastatin, compared with placebo (95% confidence interval, 0.48-0.90; P = .002).
The REPRIEVE trial was halted earlier this year for efficacy after an interim analysis pointed to a significantly lower rate of cardiovascular events in the treatment group.
The international double-blind, placebo-controlled trial randomly assigned 7,769 people with HIV infection, who were at low to moderate risk of cardiovascular disease, to either 4 mg daily of pitavastatin calcium or placebo.
The secondary outcome – a composite of major cardiovascular events and all-cause mortality – also showed a significant 21% reduction in risk with pitavastatin treatment, compared with placebo (95% CI, 0.65-0.96).
Cardiovascular events in HIV
HIV infection is an independent risk factor for cardiovascular disease, Dr. Grinspoon pointed out, and those living with HIV have about double the risk of myocardial infarction and stroke, compared with the general population.
“There’s an unmet need for people living with HIV who have low to moderate traditional risk, for whom HIV is even considered a risk equivalent but for whom no primary prevention strategy has been tested in a large trial,” Dr. Grinspoon said during an interview.
Those enrolled in the study had a 10-year Atherosclerotic Cardiovascular Disease risk score ranging from 2.1% to 7%, with a median of 4.5%. While LDL cholesterol levels at baseline ranged from 87 to 128 mg/dL, the study showed a similar reduction in cardiovascular risk regardless of LDL.
“These are types of people who, if they came to the doctor’s office right now before REPRIEVE, they would largely be told your risk score is not really making you eligible for a statin,” Dr. Grinspoon said.
He explained that what is most interesting about the reduction in risk is that it was nearly twice what would be expected with LDL lowering, based on what has previously been seen in statin trials in non–HIV-positive populations.
“I think the data are suggesting that it’s certainly in part due to the reduction in LDL – that is very important – but it’s also due to other factors beyond changes in LDL,” Dr. Grinspoon said. He speculated that the statin could be affecting anti-inflammatory and immune pathways, and that this could account for some of the reduction in cardiovascular risk, but “those data are cooking, and they’re being analyzed as we speak.”
In a substudy analysis of REPRIEVE, Markella Zanni, MD, associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, focused on the women in the clinical trial.
Women’s risk
In REPRIEVE, 31.1% of the study population were women. Dr. Zanni and her team investigated whether there are differences in the way HIV affects the risk of developing atherosclerotic cardiovascular disease in women, compared with men.
They found that women have both higher levels of inflammatory markers, such as interleukin-6, C-reactive protein, and D-dimer, but a lower prevalence of coronary artery plaques than men.
“This finding represents an interesting paradox given that high levels of select inflammatory markers have been associated with coronary artery plaque, both among women living with HIV and among men living with HIV,” Dr. Zanni explained.
She says the researchers were hoping to further explore whether inflammation is fueling the increased risk for atherosclerotic disease, and particularly the higher risk evident in women living with HIV, compared with men.
“Women living with HIV should discuss with their treating clinicians heart risks and possible prevention strategies, including statin therapy coupled with healthy lifestyle changes addressing modifiable, traditional metabolic risk factors” she said.
Time for primary prevention?
All patients in the study were on antiretroviral therapy and investigators report that pitavastatin does not interact with these medications. The median CD4 cell count was 621 cells/mm3, and 87.5% of participants had an HIV viral load below the lower limit of quantification.
Participants were enrolled from 12 countries including the United States, Spain, Brazil, South Africa, and Thailand, and around two-thirds were non-White. Individuals of South Asian ethnicity showed the biggest reduction in cardiovascular risk with pitavastatin treatment.
There was a 74% higher rate of muscle pain and weakness in the pitavastatin group – affecting 91 people in the treatment arm and 53 in the placebo arm – but the majority were low grade. The rate of rhabdomyolysis of grade 3 or above was lower in the statin group, with three cases, compared with four cases in the placebo group.
Commenting on the findings, Laura Waters, MD, a genitourinary and HIV medicine consultant at Central and North West London NHS Foundation Trust’s Mortimer Market Centre, said that, while HIV infection was considered a risk factor for cardiovascular disease, risk calculators don’t specifically adjust for HIV infection.
“Now that we’ve got effective HIV drugs and people can enjoy normal life expectancy, cardiovascular disease is a particular issue for people with HIV,” she said.
Dr. Waters, who was not involved with the study, suggested that people living with HIV should discuss the use of statins with their doctor, but she acknowledged there are some barriers to treatment in people living with HIV. “It’s another pill, and when it’s a borderline [decision] it is easy to say, ‘I have to think about it,’ ” she said, with the result that statin treatment is often deferred.
The REPRIEVE study was supported by grants from the National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare. Dr. Grinspoon declared institutional grants from National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare and consultancies unrelated to the study. Dr. Zanni reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BRISBANE, AUSTRALIA – that show pitavastatin therapy is associated with a significantly lower risk of cardiovascular events than placebo.
“There was a significant 35% lower risk of major adverse cardiovascular events after a median follow-up of 5.1 years “ said Steven Grinspoon, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, who presented the final analysis of data from the REPRIEVE trial at the International AIDS Society Conference on HIV Science.
The results were simultaneously published in the New England Journal of Medicine. The primary endpoint of major adverse cardiovascular events included a composite of outcomes that included cardiovascular death, stroke, myocardial infarction, hospitalization for unstable angina, and transient ischemic attack among those treated with pitavastatin, compared with placebo (95% confidence interval, 0.48-0.90; P = .002).
The REPRIEVE trial was halted earlier this year for efficacy after an interim analysis pointed to a significantly lower rate of cardiovascular events in the treatment group.
The international double-blind, placebo-controlled trial randomly assigned 7,769 people with HIV infection, who were at low to moderate risk of cardiovascular disease, to either 4 mg daily of pitavastatin calcium or placebo.
The secondary outcome – a composite of major cardiovascular events and all-cause mortality – also showed a significant 21% reduction in risk with pitavastatin treatment, compared with placebo (95% CI, 0.65-0.96).
Cardiovascular events in HIV
HIV infection is an independent risk factor for cardiovascular disease, Dr. Grinspoon pointed out, and those living with HIV have about double the risk of myocardial infarction and stroke, compared with the general population.
“There’s an unmet need for people living with HIV who have low to moderate traditional risk, for whom HIV is even considered a risk equivalent but for whom no primary prevention strategy has been tested in a large trial,” Dr. Grinspoon said during an interview.
Those enrolled in the study had a 10-year Atherosclerotic Cardiovascular Disease risk score ranging from 2.1% to 7%, with a median of 4.5%. While LDL cholesterol levels at baseline ranged from 87 to 128 mg/dL, the study showed a similar reduction in cardiovascular risk regardless of LDL.
“These are types of people who, if they came to the doctor’s office right now before REPRIEVE, they would largely be told your risk score is not really making you eligible for a statin,” Dr. Grinspoon said.
He explained that what is most interesting about the reduction in risk is that it was nearly twice what would be expected with LDL lowering, based on what has previously been seen in statin trials in non–HIV-positive populations.
“I think the data are suggesting that it’s certainly in part due to the reduction in LDL – that is very important – but it’s also due to other factors beyond changes in LDL,” Dr. Grinspoon said. He speculated that the statin could be affecting anti-inflammatory and immune pathways, and that this could account for some of the reduction in cardiovascular risk, but “those data are cooking, and they’re being analyzed as we speak.”
In a substudy analysis of REPRIEVE, Markella Zanni, MD, associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, focused on the women in the clinical trial.
Women’s risk
In REPRIEVE, 31.1% of the study population were women. Dr. Zanni and her team investigated whether there are differences in the way HIV affects the risk of developing atherosclerotic cardiovascular disease in women, compared with men.
They found that women have both higher levels of inflammatory markers, such as interleukin-6, C-reactive protein, and D-dimer, but a lower prevalence of coronary artery plaques than men.
“This finding represents an interesting paradox given that high levels of select inflammatory markers have been associated with coronary artery plaque, both among women living with HIV and among men living with HIV,” Dr. Zanni explained.
She says the researchers were hoping to further explore whether inflammation is fueling the increased risk for atherosclerotic disease, and particularly the higher risk evident in women living with HIV, compared with men.
“Women living with HIV should discuss with their treating clinicians heart risks and possible prevention strategies, including statin therapy coupled with healthy lifestyle changes addressing modifiable, traditional metabolic risk factors” she said.
Time for primary prevention?
All patients in the study were on antiretroviral therapy and investigators report that pitavastatin does not interact with these medications. The median CD4 cell count was 621 cells/mm3, and 87.5% of participants had an HIV viral load below the lower limit of quantification.
Participants were enrolled from 12 countries including the United States, Spain, Brazil, South Africa, and Thailand, and around two-thirds were non-White. Individuals of South Asian ethnicity showed the biggest reduction in cardiovascular risk with pitavastatin treatment.
There was a 74% higher rate of muscle pain and weakness in the pitavastatin group – affecting 91 people in the treatment arm and 53 in the placebo arm – but the majority were low grade. The rate of rhabdomyolysis of grade 3 or above was lower in the statin group, with three cases, compared with four cases in the placebo group.
Commenting on the findings, Laura Waters, MD, a genitourinary and HIV medicine consultant at Central and North West London NHS Foundation Trust’s Mortimer Market Centre, said that, while HIV infection was considered a risk factor for cardiovascular disease, risk calculators don’t specifically adjust for HIV infection.
“Now that we’ve got effective HIV drugs and people can enjoy normal life expectancy, cardiovascular disease is a particular issue for people with HIV,” she said.
Dr. Waters, who was not involved with the study, suggested that people living with HIV should discuss the use of statins with their doctor, but she acknowledged there are some barriers to treatment in people living with HIV. “It’s another pill, and when it’s a borderline [decision] it is easy to say, ‘I have to think about it,’ ” she said, with the result that statin treatment is often deferred.
The REPRIEVE study was supported by grants from the National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare. Dr. Grinspoon declared institutional grants from National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare and consultancies unrelated to the study. Dr. Zanni reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BRISBANE, AUSTRALIA – that show pitavastatin therapy is associated with a significantly lower risk of cardiovascular events than placebo.
“There was a significant 35% lower risk of major adverse cardiovascular events after a median follow-up of 5.1 years “ said Steven Grinspoon, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, who presented the final analysis of data from the REPRIEVE trial at the International AIDS Society Conference on HIV Science.
The results were simultaneously published in the New England Journal of Medicine. The primary endpoint of major adverse cardiovascular events included a composite of outcomes that included cardiovascular death, stroke, myocardial infarction, hospitalization for unstable angina, and transient ischemic attack among those treated with pitavastatin, compared with placebo (95% confidence interval, 0.48-0.90; P = .002).
The REPRIEVE trial was halted earlier this year for efficacy after an interim analysis pointed to a significantly lower rate of cardiovascular events in the treatment group.
The international double-blind, placebo-controlled trial randomly assigned 7,769 people with HIV infection, who were at low to moderate risk of cardiovascular disease, to either 4 mg daily of pitavastatin calcium or placebo.
The secondary outcome – a composite of major cardiovascular events and all-cause mortality – also showed a significant 21% reduction in risk with pitavastatin treatment, compared with placebo (95% CI, 0.65-0.96).
Cardiovascular events in HIV
HIV infection is an independent risk factor for cardiovascular disease, Dr. Grinspoon pointed out, and those living with HIV have about double the risk of myocardial infarction and stroke, compared with the general population.
“There’s an unmet need for people living with HIV who have low to moderate traditional risk, for whom HIV is even considered a risk equivalent but for whom no primary prevention strategy has been tested in a large trial,” Dr. Grinspoon said during an interview.
Those enrolled in the study had a 10-year Atherosclerotic Cardiovascular Disease risk score ranging from 2.1% to 7%, with a median of 4.5%. While LDL cholesterol levels at baseline ranged from 87 to 128 mg/dL, the study showed a similar reduction in cardiovascular risk regardless of LDL.
“These are types of people who, if they came to the doctor’s office right now before REPRIEVE, they would largely be told your risk score is not really making you eligible for a statin,” Dr. Grinspoon said.
He explained that what is most interesting about the reduction in risk is that it was nearly twice what would be expected with LDL lowering, based on what has previously been seen in statin trials in non–HIV-positive populations.
“I think the data are suggesting that it’s certainly in part due to the reduction in LDL – that is very important – but it’s also due to other factors beyond changes in LDL,” Dr. Grinspoon said. He speculated that the statin could be affecting anti-inflammatory and immune pathways, and that this could account for some of the reduction in cardiovascular risk, but “those data are cooking, and they’re being analyzed as we speak.”
In a substudy analysis of REPRIEVE, Markella Zanni, MD, associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, focused on the women in the clinical trial.
Women’s risk
In REPRIEVE, 31.1% of the study population were women. Dr. Zanni and her team investigated whether there are differences in the way HIV affects the risk of developing atherosclerotic cardiovascular disease in women, compared with men.
They found that women have both higher levels of inflammatory markers, such as interleukin-6, C-reactive protein, and D-dimer, but a lower prevalence of coronary artery plaques than men.
“This finding represents an interesting paradox given that high levels of select inflammatory markers have been associated with coronary artery plaque, both among women living with HIV and among men living with HIV,” Dr. Zanni explained.
She says the researchers were hoping to further explore whether inflammation is fueling the increased risk for atherosclerotic disease, and particularly the higher risk evident in women living with HIV, compared with men.
“Women living with HIV should discuss with their treating clinicians heart risks and possible prevention strategies, including statin therapy coupled with healthy lifestyle changes addressing modifiable, traditional metabolic risk factors” she said.
Time for primary prevention?
All patients in the study were on antiretroviral therapy and investigators report that pitavastatin does not interact with these medications. The median CD4 cell count was 621 cells/mm3, and 87.5% of participants had an HIV viral load below the lower limit of quantification.
Participants were enrolled from 12 countries including the United States, Spain, Brazil, South Africa, and Thailand, and around two-thirds were non-White. Individuals of South Asian ethnicity showed the biggest reduction in cardiovascular risk with pitavastatin treatment.
There was a 74% higher rate of muscle pain and weakness in the pitavastatin group – affecting 91 people in the treatment arm and 53 in the placebo arm – but the majority were low grade. The rate of rhabdomyolysis of grade 3 or above was lower in the statin group, with three cases, compared with four cases in the placebo group.
Commenting on the findings, Laura Waters, MD, a genitourinary and HIV medicine consultant at Central and North West London NHS Foundation Trust’s Mortimer Market Centre, said that, while HIV infection was considered a risk factor for cardiovascular disease, risk calculators don’t specifically adjust for HIV infection.
“Now that we’ve got effective HIV drugs and people can enjoy normal life expectancy, cardiovascular disease is a particular issue for people with HIV,” she said.
Dr. Waters, who was not involved with the study, suggested that people living with HIV should discuss the use of statins with their doctor, but she acknowledged there are some barriers to treatment in people living with HIV. “It’s another pill, and when it’s a borderline [decision] it is easy to say, ‘I have to think about it,’ ” she said, with the result that statin treatment is often deferred.
The REPRIEVE study was supported by grants from the National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare. Dr. Grinspoon declared institutional grants from National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare and consultancies unrelated to the study. Dr. Zanni reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT IAS 2023