HCV Hub

For injection drug users with hepatitis C virus (HCV) infection, providing treatment opportunities within a local needle exchange program can provide care to more patients and eventually cure more patients, a new study suggests.

The study’s findings help “counteract the implicit belief within the medical community that people who inject drugs can’t or don’t want to engage in health care,” lead author Benjamin Eckhardt, MD, with NYU Grossman School of Medicine, told this news organization.

“By simply focusing on patient accompaniment, limiting stigma, and removing the punitive response for missed appointments, we can effectively engage people who inject drugs in health care and more specifically cure their infection, making significant inroads to HCV elimination,” Dr. Eckhardt said.

The study was published online  in JAMA Internal Medicine.
 

Nonjudgmental, patient-centered approach

Researchers included 165 injection drug users with HCV (mean age, 42 years; 78% men); 82 were randomly allocated to the accessible care intervention and 83 to a usual care control group.

The accessible care model provides HCV treatment within a community-based needle exchange program in a comfortable, nonjudgmental atmosphere, “without fear of shame or stigma that people who inject drugs often experience in mainstream institutions,” the investigators explain.

Control participants were connected to a patient navigator who facilitated referrals to community direct antigen antiviral therapy programs that were not at a syringe service program.

In an intent-to-treat analysis, those enrolled in the accessible care group achieved sustained viral eradication at 12 months at significantly higher rates than those in the control group (67% vs. 23%; P < .001).

Once patients initiated treatment, cure rates were the same in both groups (86%), indicating that the major benefit of the accessible care program was in facilitating treatment, rather than increasing adherence to or response to treatment, the researchers noted.

This is reflected in the fact that the percentage of participants who advanced along the care cascade was significantly higher at each step for the accessible care group than the control group, from referral to an HCV clinician (93% vs. 45%), attendance of the initial HCV clinical visit (87% vs. 37%), completion of baseline laboratory testing (87% vs. 31%), and treatment initiation (78% vs. 27%).
 

Getting to the population in need

“The most surprising aspect of the study was how successful we were at recruiting, engaging, and treating people who inject drugs who lived outside the immediate community where the syringe exchange program was located and had no prior connection to the program,” Dr. Eckhardt said.

“We had numerous individuals travel 45-plus minutes on the subway from the South Bronx, passing four major medical centers with robust hepatitis C treatment programs, to seek care for hepatitis C in a small, dark office – but also an office they’d heard can be trusted – without fear of stigma or preconditions,” Dr. Eckhardt said.

Commenting on the study’s findings, Nancy Reau, MD, section chief of hepatology at Rush Medical College, Chicago, said, “This is another successful example of making therapy accessible to the population who is in need versus trying to move them into a tertiary care model.”

Dr. Reau noted that similar care models exist in the United States but are not always accessible to the population in need.

“The safety and efficacy of current therapy and the simplified care cascade make HCV an appropriate disease for this delivery,” she said, adding that this study “highlights not just the importance of these programs but also the necessity of engaging the medical community, changing policy, and using patient navigators and monetary support/prioritization to provide appropriate HCV management to those who are at high risk for the disease and for transmission.”
 

Accessible care beyond HCV

The coauthors of an accompanying editor’s note point out that the treatment for HCV has improved substantially, but it can be a real challenge to provide treatment to injection drug users because the U.S. health care system is not oriented toward the needs of this population.

“It is not surprising that the accessible care arm achieved a higher rate of viral eradication, as it created a patient-focused experience,” write Asha Choudhury, MD, MPH, with the University of California, San Francisco, and Mitchell Katz, MD, with NYC Health and Hospitals. “Creating inviting and engaging environments is particularly important when caring for patients from stigmatized groups. Having more sites that are accessible and inclusive like this for treating patients will likely increase treatment of hepatitis C.”

In their view, the study raises “two dueling questions: Is this model replicable across the U.S.? And, conversely, why isn’t all medical care offered in friendly, nonjudgmental settings with the intention of meeting patient goals?”

They conclude that the study’s lessons extend beyond this particular population and have implications for the field at large.

“The model is replicable to the extent that health care systems are prepared to provide nonjudgmental supportive care for persons who inject drugs,” they write. “However, all patients would benefit from a health care system that provided more patient-centered environments.”

The study was funded by the National Institute on Drug Abuse. Dr. Eckhardt reports receiving grants from the National Institutes of Health and Gilead during the conduct of the study. Dr. Choudhury, Dr. Katz, and Dr. Reau report no relevant financial relationships.

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

For injection drug users with hepatitis C virus (HCV) infection, providing treatment opportunities within a local needle exchange program can provide care to more patients and eventually cure more patients, a new study suggests.

The study’s findings help “counteract the implicit belief within the medical community that people who inject drugs can’t or don’t want to engage in health care,” lead author Benjamin Eckhardt, MD, with NYU Grossman School of Medicine, told this news organization.

“By simply focusing on patient accompaniment, limiting stigma, and removing the punitive response for missed appointments, we can effectively engage people who inject drugs in health care and more specifically cure their infection, making significant inroads to HCV elimination,” Dr. Eckhardt said.

The study was published online  in JAMA Internal Medicine.
 

Nonjudgmental, patient-centered approach

Researchers included 165 injection drug users with HCV (mean age, 42 years; 78% men); 82 were randomly allocated to the accessible care intervention and 83 to a usual care control group.

The accessible care model provides HCV treatment within a community-based needle exchange program in a comfortable, nonjudgmental atmosphere, “without fear of shame or stigma that people who inject drugs often experience in mainstream institutions,” the investigators explain.

Control participants were connected to a patient navigator who facilitated referrals to community direct antigen antiviral therapy programs that were not at a syringe service program.

In an intent-to-treat analysis, those enrolled in the accessible care group achieved sustained viral eradication at 12 months at significantly higher rates than those in the control group (67% vs. 23%; P < .001).

Once patients initiated treatment, cure rates were the same in both groups (86%), indicating that the major benefit of the accessible care program was in facilitating treatment, rather than increasing adherence to or response to treatment, the researchers noted.

This is reflected in the fact that the percentage of participants who advanced along the care cascade was significantly higher at each step for the accessible care group than the control group, from referral to an HCV clinician (93% vs. 45%), attendance of the initial HCV clinical visit (87% vs. 37%), completion of baseline laboratory testing (87% vs. 31%), and treatment initiation (78% vs. 27%).
 

Getting to the population in need

“The most surprising aspect of the study was how successful we were at recruiting, engaging, and treating people who inject drugs who lived outside the immediate community where the syringe exchange program was located and had no prior connection to the program,” Dr. Eckhardt said.

“We had numerous individuals travel 45-plus minutes on the subway from the South Bronx, passing four major medical centers with robust hepatitis C treatment programs, to seek care for hepatitis C in a small, dark office – but also an office they’d heard can be trusted – without fear of stigma or preconditions,” Dr. Eckhardt said.

Commenting on the study’s findings, Nancy Reau, MD, section chief of hepatology at Rush Medical College, Chicago, said, “This is another successful example of making therapy accessible to the population who is in need versus trying to move them into a tertiary care model.”

Dr. Reau noted that similar care models exist in the United States but are not always accessible to the population in need.

“The safety and efficacy of current therapy and the simplified care cascade make HCV an appropriate disease for this delivery,” she said, adding that this study “highlights not just the importance of these programs but also the necessity of engaging the medical community, changing policy, and using patient navigators and monetary support/prioritization to provide appropriate HCV management to those who are at high risk for the disease and for transmission.”
 

Accessible care beyond HCV

The coauthors of an accompanying editor’s note point out that the treatment for HCV has improved substantially, but it can be a real challenge to provide treatment to injection drug users because the U.S. health care system is not oriented toward the needs of this population.

“It is not surprising that the accessible care arm achieved a higher rate of viral eradication, as it created a patient-focused experience,” write Asha Choudhury, MD, MPH, with the University of California, San Francisco, and Mitchell Katz, MD, with NYC Health and Hospitals. “Creating inviting and engaging environments is particularly important when caring for patients from stigmatized groups. Having more sites that are accessible and inclusive like this for treating patients will likely increase treatment of hepatitis C.”

In their view, the study raises “two dueling questions: Is this model replicable across the U.S.? And, conversely, why isn’t all medical care offered in friendly, nonjudgmental settings with the intention of meeting patient goals?”

They conclude that the study’s lessons extend beyond this particular population and have implications for the field at large.

“The model is replicable to the extent that health care systems are prepared to provide nonjudgmental supportive care for persons who inject drugs,” they write. “However, all patients would benefit from a health care system that provided more patient-centered environments.”

The study was funded by the National Institute on Drug Abuse. Dr. Eckhardt reports receiving grants from the National Institutes of Health and Gilead during the conduct of the study. Dr. Choudhury, Dr. Katz, and Dr. Reau report no relevant financial relationships.

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

For injection drug users with hepatitis C virus (HCV) infection, providing treatment opportunities within a local needle exchange program can provide care to more patients and eventually cure more patients, a new study suggests.

The study’s findings help “counteract the implicit belief within the medical community that people who inject drugs can’t or don’t want to engage in health care,” lead author Benjamin Eckhardt, MD, with NYU Grossman School of Medicine, told this news organization.

“By simply focusing on patient accompaniment, limiting stigma, and removing the punitive response for missed appointments, we can effectively engage people who inject drugs in health care and more specifically cure their infection, making significant inroads to HCV elimination,” Dr. Eckhardt said.

The study was published online  in JAMA Internal Medicine.
 

Nonjudgmental, patient-centered approach

Researchers included 165 injection drug users with HCV (mean age, 42 years; 78% men); 82 were randomly allocated to the accessible care intervention and 83 to a usual care control group.

The accessible care model provides HCV treatment within a community-based needle exchange program in a comfortable, nonjudgmental atmosphere, “without fear of shame or stigma that people who inject drugs often experience in mainstream institutions,” the investigators explain.

Control participants were connected to a patient navigator who facilitated referrals to community direct antigen antiviral therapy programs that were not at a syringe service program.

In an intent-to-treat analysis, those enrolled in the accessible care group achieved sustained viral eradication at 12 months at significantly higher rates than those in the control group (67% vs. 23%; P < .001).

Once patients initiated treatment, cure rates were the same in both groups (86%), indicating that the major benefit of the accessible care program was in facilitating treatment, rather than increasing adherence to or response to treatment, the researchers noted.

This is reflected in the fact that the percentage of participants who advanced along the care cascade was significantly higher at each step for the accessible care group than the control group, from referral to an HCV clinician (93% vs. 45%), attendance of the initial HCV clinical visit (87% vs. 37%), completion of baseline laboratory testing (87% vs. 31%), and treatment initiation (78% vs. 27%).
 

Getting to the population in need

“The most surprising aspect of the study was how successful we were at recruiting, engaging, and treating people who inject drugs who lived outside the immediate community where the syringe exchange program was located and had no prior connection to the program,” Dr. Eckhardt said.

“We had numerous individuals travel 45-plus minutes on the subway from the South Bronx, passing four major medical centers with robust hepatitis C treatment programs, to seek care for hepatitis C in a small, dark office – but also an office they’d heard can be trusted – without fear of stigma or preconditions,” Dr. Eckhardt said.

Commenting on the study’s findings, Nancy Reau, MD, section chief of hepatology at Rush Medical College, Chicago, said, “This is another successful example of making therapy accessible to the population who is in need versus trying to move them into a tertiary care model.”

Dr. Reau noted that similar care models exist in the United States but are not always accessible to the population in need.

“The safety and efficacy of current therapy and the simplified care cascade make HCV an appropriate disease for this delivery,” she said, adding that this study “highlights not just the importance of these programs but also the necessity of engaging the medical community, changing policy, and using patient navigators and monetary support/prioritization to provide appropriate HCV management to those who are at high risk for the disease and for transmission.”
 

Accessible care beyond HCV

The coauthors of an accompanying editor’s note point out that the treatment for HCV has improved substantially, but it can be a real challenge to provide treatment to injection drug users because the U.S. health care system is not oriented toward the needs of this population.

“It is not surprising that the accessible care arm achieved a higher rate of viral eradication, as it created a patient-focused experience,” write Asha Choudhury, MD, MPH, with the University of California, San Francisco, and Mitchell Katz, MD, with NYC Health and Hospitals. “Creating inviting and engaging environments is particularly important when caring for patients from stigmatized groups. Having more sites that are accessible and inclusive like this for treating patients will likely increase treatment of hepatitis C.”

In their view, the study raises “two dueling questions: Is this model replicable across the U.S.? And, conversely, why isn’t all medical care offered in friendly, nonjudgmental settings with the intention of meeting patient goals?”

They conclude that the study’s lessons extend beyond this particular population and have implications for the field at large.

“The model is replicable to the extent that health care systems are prepared to provide nonjudgmental supportive care for persons who inject drugs,” they write. “However, all patients would benefit from a health care system that provided more patient-centered environments.”

The study was funded by the National Institute on Drug Abuse. Dr. Eckhardt reports receiving grants from the National Institutes of Health and Gilead during the conduct of the study. Dr. Choudhury, Dr. Katz, and Dr. Reau report no relevant financial relationships.

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

Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

Jarlenski_Marian_PA_web.jpg

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Terplan_Mishka_MD_web.jpg

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.

Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

Jarlenski_Marian_PA_web.jpg

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Terplan_Mishka_MD_web.jpg

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.

Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

Jarlenski_Marian_PA_web.jpg

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Terplan_Mishka_MD_web.jpg

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.

Liver transplantation using hepatitis C virus (HCV)-seropositive grafts to HCV-seronegative recipients resulted in “excellent short-term outcomes,” according to the results of a prospective, multicenter study reported in the Journal of Hepatology.

A total of 34 HCV– liver transplantation recipients received grafts from HCV+ donors (20 HCV viremic and 14 nonviremic) from January 2018 to September 2019, according to Bashar Aqel, MD, of the Mayo Clinic, Phoenix, Ariz., and colleagues.

Seven of the grafts were obtained from donation after cardiac death (DCD). Six recipients underwent simultaneous liver/kidney (SLK) transplant, and four patients were repeat liver transplants.
 

Sustained viral response

None of the recipients of an HCV nonviremic graft developed HCV viremia. However, all 20 patients who received HCV viremic grafts had HCV viremia confirmed within 3 days after liver transplant. Direct-acting antiviral (DAA) treatment was started at the median time of 27.5 days in these patients.

All 20 patients successfully completed the treatment and achieved a sustained viral response. In addition, the DAA treatment was well tolerated with minimal adverse events, according to the researchers.

However, one patient died, having developed HCV-related acute membranous nephropathy that resulted in end-stage kidney disease. In addition, a recipient of an HCV nonviremic graft died with acute myocardial infarction 610 days post liver transplant, the authors reported.

“This multicenter study demonstrated LT [liver transplantation] using HCV-seropositive grafts to HCV-seronegative recipients resulted in acceptable short-term outcomes even with the use of DCD grafts and expansion into SLK or repeat LT. However, a careful ongoing assessment regarding patient and graft selection, complications, and the timing of treatment is required,” the researchers concluded.

The study was funded in part by the McIver Estate Young Investigator Benefactor Award. The authors reported they had no potential conflicts.

mlesney@mdedge.com

SOURCE: Aqel B et al. J Hepatol. 2020, Nov 11. doi: 10.1016/j.jhep.2020.11.005.

Liver transplantation using hepatitis C virus (HCV)-seropositive grafts to HCV-seronegative recipients resulted in “excellent short-term outcomes,” according to the results of a prospective, multicenter study reported in the Journal of Hepatology.

A total of 34 HCV– liver transplantation recipients received grafts from HCV+ donors (20 HCV viremic and 14 nonviremic) from January 2018 to September 2019, according to Bashar Aqel, MD, of the Mayo Clinic, Phoenix, Ariz., and colleagues.

Seven of the grafts were obtained from donation after cardiac death (DCD). Six recipients underwent simultaneous liver/kidney (SLK) transplant, and four patients were repeat liver transplants.
 

Sustained viral response

None of the recipients of an HCV nonviremic graft developed HCV viremia. However, all 20 patients who received HCV viremic grafts had HCV viremia confirmed within 3 days after liver transplant. Direct-acting antiviral (DAA) treatment was started at the median time of 27.5 days in these patients.

All 20 patients successfully completed the treatment and achieved a sustained viral response. In addition, the DAA treatment was well tolerated with minimal adverse events, according to the researchers.

However, one patient died, having developed HCV-related acute membranous nephropathy that resulted in end-stage kidney disease. In addition, a recipient of an HCV nonviremic graft died with acute myocardial infarction 610 days post liver transplant, the authors reported.

“This multicenter study demonstrated LT [liver transplantation] using HCV-seropositive grafts to HCV-seronegative recipients resulted in acceptable short-term outcomes even with the use of DCD grafts and expansion into SLK or repeat LT. However, a careful ongoing assessment regarding patient and graft selection, complications, and the timing of treatment is required,” the researchers concluded.

The study was funded in part by the McIver Estate Young Investigator Benefactor Award. The authors reported they had no potential conflicts.

mlesney@mdedge.com

SOURCE: Aqel B et al. J Hepatol. 2020, Nov 11. doi: 10.1016/j.jhep.2020.11.005.

Liver transplantation using hepatitis C virus (HCV)-seropositive grafts to HCV-seronegative recipients resulted in “excellent short-term outcomes,” according to the results of a prospective, multicenter study reported in the Journal of Hepatology.

A total of 34 HCV– liver transplantation recipients received grafts from HCV+ donors (20 HCV viremic and 14 nonviremic) from January 2018 to September 2019, according to Bashar Aqel, MD, of the Mayo Clinic, Phoenix, Ariz., and colleagues.

Seven of the grafts were obtained from donation after cardiac death (DCD). Six recipients underwent simultaneous liver/kidney (SLK) transplant, and four patients were repeat liver transplants.
 

Sustained viral response

None of the recipients of an HCV nonviremic graft developed HCV viremia. However, all 20 patients who received HCV viremic grafts had HCV viremia confirmed within 3 days after liver transplant. Direct-acting antiviral (DAA) treatment was started at the median time of 27.5 days in these patients.

All 20 patients successfully completed the treatment and achieved a sustained viral response. In addition, the DAA treatment was well tolerated with minimal adverse events, according to the researchers.

However, one patient died, having developed HCV-related acute membranous nephropathy that resulted in end-stage kidney disease. In addition, a recipient of an HCV nonviremic graft died with acute myocardial infarction 610 days post liver transplant, the authors reported.

“This multicenter study demonstrated LT [liver transplantation] using HCV-seropositive grafts to HCV-seronegative recipients resulted in acceptable short-term outcomes even with the use of DCD grafts and expansion into SLK or repeat LT. However, a careful ongoing assessment regarding patient and graft selection, complications, and the timing of treatment is required,” the researchers concluded.

The study was funded in part by the McIver Estate Young Investigator Benefactor Award. The authors reported they had no potential conflicts.

mlesney@mdedge.com

SOURCE: Aqel B et al. J Hepatol. 2020, Nov 11. doi: 10.1016/j.jhep.2020.11.005.

Patients with hepatitis C virus (HCV) genotype 3 infection have shown resistance to direct-acting antiviral (DAA) treatments. However, a meta-analysis of 34 research reports found that DAA combo treatment can be effective in achieving sustained virologic response (SVR) in patients with HCV genotype 3, according to a study published online in Annals of Hepatology.

This study aimed to analyze the effectiveness of four regimens: sofosbuvir (SOF)/daclatasvir (DCV) with or without ribavirin (RBV); SOF/velpatasvir (VEL) with or without RBV; SOF/VEL/voxilaprevir (VOX);and glecaprevir (GLE)/pibrentasvir (PIB) in the treatment of HCV genotype 3–infected patients in real-world situations, according to Liwei Zhuang, of Beijing Ditan Hospital, Capital Medical University, and colleagues.

A total of 34 studies, comprising 7,328 patients from 22 countries, met the inclusion criteria and formed the basis of the analysis.
 

Promising results

The pooled SVR rate after 12 or 24 weeks of treatment for the four regimens was 92.1%.

For each regimen, the SVR rate was 91.2% in patients treated with SOF/DCV with or without RBV; 95.1% in patients treated with SOF/VEL with or without RBV; 85.0% in patients treated with SOF/VEL/VOX; and 98.5% in patients treated with GLE/PIB.

In addition, the pooled SVR rate of the four regimens was 95.2% in patients without cirrhosis and 89.4% in patients with cirrhosis, and the pooled SVR rate was 94.4% in treatment-naive patients and 88.0% in treatment-experienced patients. All results were within 95% confidence intervals.

The researchers pointed out that their meta-analysis had limitations. “We think that no strong conclusions can be drawn due to high heterogeneity in four DAA regimens administration in real-world setting from 22 countries, as well as small numbers of patients treated with SOF + VEL + VOX and GLE + PIB. More studies are needed in the future in order to better analyze the antiviral effectiveness of DAAs in GT3 HCV patients in real-world studies,” they authors stated.

However, they also concluded that “the antiviral effectiveness of treatment regimens for HCV-GT3 [genotype 3] infection, including SOF + DCV ± RBV, SOF + VEL ± RBV, GLE + PIB, and SOF + VEL + VOX, was good. The SVR rate of GLE + PIB was higher, and the treatment duration was shorter than other regimens.”

The study was funded by the Chinese government and public institutions. The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhuang L et al. Ann Hepatol. 2020 Oct 12. doi: 10.1016/j.aohep.2020.09.012.

Patients with hepatitis C virus (HCV) genotype 3 infection have shown resistance to direct-acting antiviral (DAA) treatments. However, a meta-analysis of 34 research reports found that DAA combo treatment can be effective in achieving sustained virologic response (SVR) in patients with HCV genotype 3, according to a study published online in Annals of Hepatology.

This study aimed to analyze the effectiveness of four regimens: sofosbuvir (SOF)/daclatasvir (DCV) with or without ribavirin (RBV); SOF/velpatasvir (VEL) with or without RBV; SOF/VEL/voxilaprevir (VOX);and glecaprevir (GLE)/pibrentasvir (PIB) in the treatment of HCV genotype 3–infected patients in real-world situations, according to Liwei Zhuang, of Beijing Ditan Hospital, Capital Medical University, and colleagues.

A total of 34 studies, comprising 7,328 patients from 22 countries, met the inclusion criteria and formed the basis of the analysis.
 

Promising results

The pooled SVR rate after 12 or 24 weeks of treatment for the four regimens was 92.1%.

For each regimen, the SVR rate was 91.2% in patients treated with SOF/DCV with or without RBV; 95.1% in patients treated with SOF/VEL with or without RBV; 85.0% in patients treated with SOF/VEL/VOX; and 98.5% in patients treated with GLE/PIB.

In addition, the pooled SVR rate of the four regimens was 95.2% in patients without cirrhosis and 89.4% in patients with cirrhosis, and the pooled SVR rate was 94.4% in treatment-naive patients and 88.0% in treatment-experienced patients. All results were within 95% confidence intervals.

The researchers pointed out that their meta-analysis had limitations. “We think that no strong conclusions can be drawn due to high heterogeneity in four DAA regimens administration in real-world setting from 22 countries, as well as small numbers of patients treated with SOF + VEL + VOX and GLE + PIB. More studies are needed in the future in order to better analyze the antiviral effectiveness of DAAs in GT3 HCV patients in real-world studies,” they authors stated.

However, they also concluded that “the antiviral effectiveness of treatment regimens for HCV-GT3 [genotype 3] infection, including SOF + DCV ± RBV, SOF + VEL ± RBV, GLE + PIB, and SOF + VEL + VOX, was good. The SVR rate of GLE + PIB was higher, and the treatment duration was shorter than other regimens.”

The study was funded by the Chinese government and public institutions. The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhuang L et al. Ann Hepatol. 2020 Oct 12. doi: 10.1016/j.aohep.2020.09.012.

Patients with hepatitis C virus (HCV) genotype 3 infection have shown resistance to direct-acting antiviral (DAA) treatments. However, a meta-analysis of 34 research reports found that DAA combo treatment can be effective in achieving sustained virologic response (SVR) in patients with HCV genotype 3, according to a study published online in Annals of Hepatology.

This study aimed to analyze the effectiveness of four regimens: sofosbuvir (SOF)/daclatasvir (DCV) with or without ribavirin (RBV); SOF/velpatasvir (VEL) with or without RBV; SOF/VEL/voxilaprevir (VOX);and glecaprevir (GLE)/pibrentasvir (PIB) in the treatment of HCV genotype 3–infected patients in real-world situations, according to Liwei Zhuang, of Beijing Ditan Hospital, Capital Medical University, and colleagues.

A total of 34 studies, comprising 7,328 patients from 22 countries, met the inclusion criteria and formed the basis of the analysis.
 

Promising results

The pooled SVR rate after 12 or 24 weeks of treatment for the four regimens was 92.1%.

For each regimen, the SVR rate was 91.2% in patients treated with SOF/DCV with or without RBV; 95.1% in patients treated with SOF/VEL with or without RBV; 85.0% in patients treated with SOF/VEL/VOX; and 98.5% in patients treated with GLE/PIB.

In addition, the pooled SVR rate of the four regimens was 95.2% in patients without cirrhosis and 89.4% in patients with cirrhosis, and the pooled SVR rate was 94.4% in treatment-naive patients and 88.0% in treatment-experienced patients. All results were within 95% confidence intervals.

The researchers pointed out that their meta-analysis had limitations. “We think that no strong conclusions can be drawn due to high heterogeneity in four DAA regimens administration in real-world setting from 22 countries, as well as small numbers of patients treated with SOF + VEL + VOX and GLE + PIB. More studies are needed in the future in order to better analyze the antiviral effectiveness of DAAs in GT3 HCV patients in real-world studies,” they authors stated.

However, they also concluded that “the antiviral effectiveness of treatment regimens for HCV-GT3 [genotype 3] infection, including SOF + DCV ± RBV, SOF + VEL ± RBV, GLE + PIB, and SOF + VEL + VOX, was good. The SVR rate of GLE + PIB was higher, and the treatment duration was shorter than other regimens.”

The study was funded by the Chinese government and public institutions. The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhuang L et al. Ann Hepatol. 2020 Oct 12. doi: 10.1016/j.aohep.2020.09.012.

Current risk factors used to screen for hepatitis C should be updated, according to study results of 106,842 pregnant women who underwent screening.

hepatitis_C_2_web.jpg

“Because risk-factor screening has obvious limitations, universal screening in pregnancy has been suggested to allow for linkage to postpartum care and identification of children for future testing and treatment,” wrote Mona Prasad, DO, of Ohio State University, Columbus, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from women with singleton pregnancies presenting for prenatal care prior to 23 weeks’ gestation during 2012-2015. Of these, 254 tested positive for the hepatitis C virus (HCV) antibody, for a seroprevalence rate of 2.4 cases per 1,000 women.

The researchers conducted a case-control analysis of 131 women who tested positive and 251 controls to identify HCV infection risk factors based on interviews and chart reviews. They found that risk factors significantly associated with positive HCV antibodies included injection drug use (adjusted odds ratio, 22.9), a history of blood transfusion (aOR, 3.7), having an HCV-infected partner (aOR, 6.3), having had more than three sexual partners (aOR, 5.3), and smoking during pregnancy (aOR, 2.4).

In an unadjusted analysis, the researchers confirmed two of the risk factors currently recommended by the Centers for Disease Control and Prevention for screening for HCV: injection drug use and being born to a mother with HCV infection, but not dialysis, organ transplantation, or HIV infection.

“Our results demonstrate that current risk factors could be contemporized,” Dr. Prasad and colleagues noted. “The currently accepted risk factors such as exposure to clotting factors, dialysis, and organ transplants are unlikely to be found. A thorough assessment of injection drug use history, smoking, transfusions, number of sexual partners, and partners with HCV infection is more sensitive in an obstetric population.”

The study findings were limited by several factors including possible selection bias and inclusion of only 65% of eligible women who were HCV positive, as well as a lack of screening data from 2016 to the present, which may not reflect the impact of the recent opioid epidemic, the researchers noted. However, the results were strengthened by the large sample size, and the generalizability of the study population.

“Our results regarding prevalence rates and risk factors of HCV antibody among pregnant women in the United States will be valuable to policymakers as they weigh the costs and benefits of universal screening,” Dr. Prasad and associates concluded.

Although universal screening has the potential to be more cost effective, given the small population of pregnant women eligible for treatment and lack of an available treatment, “the rationale is weaker for unique universal HCV screening recommendations for pregnant women,” they said.

By contrast, Sammy Saab, MD, MPH, of the University of California, Los Angeles; Ravina Kullar, PharmD, MPH, of Gilead Sciences, Foster City, Calif.; and Prabhu Gounder, MD, MPH, of the Los Angeles Department of Public Health, wrote an accompanying commentary in favor of universal HCV screening for pregnant women, in part because of the increase in HCV in the younger population overall.

“For many women of reproductive age, pregnancy is one of their few points of contact with their health care provider; therefore, pregnancy could provide a crucial time for targeting this population,” they noted.

Risk-based screening is of limited effectiveness because patients are not identified by way of current screening tools or they decline to reveal risk factors that providers might miss, the editorialists said. Pregnancy has not been shown to affect the accuracy of HCV tests, and identifying infections in mothers allows for screening in children as well.

“The perinatal hepatitis B virus infection program, which has been implemented in several state and local public health departments, could serve as an example for how to conduct surveillance for mothers with HCV infection and to ensure that HCV-exposed children receive appropriate follow-up testing and linkage to care,” the editorialists concluded.

The study was supported in part by multiple grants from the National Institute of Child Health and Human Development. Dr. Prasad disclosed funding from Ohio State University and from Gilead. Coauthors had links with pharmaceutical companies, associations, and organizations – most unrelated to this study. The editorialists had no financial conflicts to disclose.

SOURCES: Prasad M et al. Obstet Gynecol. 2020;135:778-88; Saab S et al. Obstet Gynecol. 2020;135:773-7.

Current risk factors used to screen for hepatitis C should be updated, according to study results of 106,842 pregnant women who underwent screening.

hepatitis_C_2_web.jpg

“Because risk-factor screening has obvious limitations, universal screening in pregnancy has been suggested to allow for linkage to postpartum care and identification of children for future testing and treatment,” wrote Mona Prasad, DO, of Ohio State University, Columbus, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from women with singleton pregnancies presenting for prenatal care prior to 23 weeks’ gestation during 2012-2015. Of these, 254 tested positive for the hepatitis C virus (HCV) antibody, for a seroprevalence rate of 2.4 cases per 1,000 women.

The researchers conducted a case-control analysis of 131 women who tested positive and 251 controls to identify HCV infection risk factors based on interviews and chart reviews. They found that risk factors significantly associated with positive HCV antibodies included injection drug use (adjusted odds ratio, 22.9), a history of blood transfusion (aOR, 3.7), having an HCV-infected partner (aOR, 6.3), having had more than three sexual partners (aOR, 5.3), and smoking during pregnancy (aOR, 2.4).

In an unadjusted analysis, the researchers confirmed two of the risk factors currently recommended by the Centers for Disease Control and Prevention for screening for HCV: injection drug use and being born to a mother with HCV infection, but not dialysis, organ transplantation, or HIV infection.

“Our results demonstrate that current risk factors could be contemporized,” Dr. Prasad and colleagues noted. “The currently accepted risk factors such as exposure to clotting factors, dialysis, and organ transplants are unlikely to be found. A thorough assessment of injection drug use history, smoking, transfusions, number of sexual partners, and partners with HCV infection is more sensitive in an obstetric population.”

The study findings were limited by several factors including possible selection bias and inclusion of only 65% of eligible women who were HCV positive, as well as a lack of screening data from 2016 to the present, which may not reflect the impact of the recent opioid epidemic, the researchers noted. However, the results were strengthened by the large sample size, and the generalizability of the study population.

“Our results regarding prevalence rates and risk factors of HCV antibody among pregnant women in the United States will be valuable to policymakers as they weigh the costs and benefits of universal screening,” Dr. Prasad and associates concluded.

Although universal screening has the potential to be more cost effective, given the small population of pregnant women eligible for treatment and lack of an available treatment, “the rationale is weaker for unique universal HCV screening recommendations for pregnant women,” they said.

By contrast, Sammy Saab, MD, MPH, of the University of California, Los Angeles; Ravina Kullar, PharmD, MPH, of Gilead Sciences, Foster City, Calif.; and Prabhu Gounder, MD, MPH, of the Los Angeles Department of Public Health, wrote an accompanying commentary in favor of universal HCV screening for pregnant women, in part because of the increase in HCV in the younger population overall.

“For many women of reproductive age, pregnancy is one of their few points of contact with their health care provider; therefore, pregnancy could provide a crucial time for targeting this population,” they noted.

Risk-based screening is of limited effectiveness because patients are not identified by way of current screening tools or they decline to reveal risk factors that providers might miss, the editorialists said. Pregnancy has not been shown to affect the accuracy of HCV tests, and identifying infections in mothers allows for screening in children as well.

“The perinatal hepatitis B virus infection program, which has been implemented in several state and local public health departments, could serve as an example for how to conduct surveillance for mothers with HCV infection and to ensure that HCV-exposed children receive appropriate follow-up testing and linkage to care,” the editorialists concluded.

The study was supported in part by multiple grants from the National Institute of Child Health and Human Development. Dr. Prasad disclosed funding from Ohio State University and from Gilead. Coauthors had links with pharmaceutical companies, associations, and organizations – most unrelated to this study. The editorialists had no financial conflicts to disclose.

SOURCES: Prasad M et al. Obstet Gynecol. 2020;135:778-88; Saab S et al. Obstet Gynecol. 2020;135:773-7.

Current risk factors used to screen for hepatitis C should be updated, according to study results of 106,842 pregnant women who underwent screening.

hepatitis_C_2_web.jpg

“Because risk-factor screening has obvious limitations, universal screening in pregnancy has been suggested to allow for linkage to postpartum care and identification of children for future testing and treatment,” wrote Mona Prasad, DO, of Ohio State University, Columbus, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from women with singleton pregnancies presenting for prenatal care prior to 23 weeks’ gestation during 2012-2015. Of these, 254 tested positive for the hepatitis C virus (HCV) antibody, for a seroprevalence rate of 2.4 cases per 1,000 women.

The researchers conducted a case-control analysis of 131 women who tested positive and 251 controls to identify HCV infection risk factors based on interviews and chart reviews. They found that risk factors significantly associated with positive HCV antibodies included injection drug use (adjusted odds ratio, 22.9), a history of blood transfusion (aOR, 3.7), having an HCV-infected partner (aOR, 6.3), having had more than three sexual partners (aOR, 5.3), and smoking during pregnancy (aOR, 2.4).

In an unadjusted analysis, the researchers confirmed two of the risk factors currently recommended by the Centers for Disease Control and Prevention for screening for HCV: injection drug use and being born to a mother with HCV infection, but not dialysis, organ transplantation, or HIV infection.

“Our results demonstrate that current risk factors could be contemporized,” Dr. Prasad and colleagues noted. “The currently accepted risk factors such as exposure to clotting factors, dialysis, and organ transplants are unlikely to be found. A thorough assessment of injection drug use history, smoking, transfusions, number of sexual partners, and partners with HCV infection is more sensitive in an obstetric population.”

The study findings were limited by several factors including possible selection bias and inclusion of only 65% of eligible women who were HCV positive, as well as a lack of screening data from 2016 to the present, which may not reflect the impact of the recent opioid epidemic, the researchers noted. However, the results were strengthened by the large sample size, and the generalizability of the study population.

“Our results regarding prevalence rates and risk factors of HCV antibody among pregnant women in the United States will be valuable to policymakers as they weigh the costs and benefits of universal screening,” Dr. Prasad and associates concluded.

Although universal screening has the potential to be more cost effective, given the small population of pregnant women eligible for treatment and lack of an available treatment, “the rationale is weaker for unique universal HCV screening recommendations for pregnant women,” they said.

By contrast, Sammy Saab, MD, MPH, of the University of California, Los Angeles; Ravina Kullar, PharmD, MPH, of Gilead Sciences, Foster City, Calif.; and Prabhu Gounder, MD, MPH, of the Los Angeles Department of Public Health, wrote an accompanying commentary in favor of universal HCV screening for pregnant women, in part because of the increase in HCV in the younger population overall.

“For many women of reproductive age, pregnancy is one of their few points of contact with their health care provider; therefore, pregnancy could provide a crucial time for targeting this population,” they noted.

Risk-based screening is of limited effectiveness because patients are not identified by way of current screening tools or they decline to reveal risk factors that providers might miss, the editorialists said. Pregnancy has not been shown to affect the accuracy of HCV tests, and identifying infections in mothers allows for screening in children as well.

“The perinatal hepatitis B virus infection program, which has been implemented in several state and local public health departments, could serve as an example for how to conduct surveillance for mothers with HCV infection and to ensure that HCV-exposed children receive appropriate follow-up testing and linkage to care,” the editorialists concluded.

The study was supported in part by multiple grants from the National Institute of Child Health and Human Development. Dr. Prasad disclosed funding from Ohio State University and from Gilead. Coauthors had links with pharmaceutical companies, associations, and organizations – most unrelated to this study. The editorialists had no financial conflicts to disclose.

SOURCES: Prasad M et al. Obstet Gynecol. 2020;135:778-88; Saab S et al. Obstet Gynecol. 2020;135:773-7.

LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.

145132_Gonzalez_Stevan_A_web.jpg

That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.

About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”

Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
[embed:render:related:node:218018]

At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.

“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.

More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.

Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.

From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).

Surprising exposure risk

The primary risk of transmission is through contaminated blood and the exposure through needles.

“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.

“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.

“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”

The duration of a person’s HCV infection drives the transmission.

“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”

One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)

HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.

“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
 

Weighing treatment options

The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.

“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”

All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.

Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.

“That’s lower than people expect,” Dr. Gonzalez said.
 

How to boost screening

Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.

In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.

The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.

Other efforts to expand access to screening and treatment are underway.

In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.

“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.

Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.

“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”

Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.

“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.

“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”

Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.

dbrunk@mdedge.com

LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.

145132_Gonzalez_Stevan_A_web.jpg

That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.

About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”

Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
[embed:render:related:node:218018]

At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.

“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.

More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.

Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.

From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).

Surprising exposure risk

The primary risk of transmission is through contaminated blood and the exposure through needles.

“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.

“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.

“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”

The duration of a person’s HCV infection drives the transmission.

“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”

One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)

HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.

“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
 

Weighing treatment options

The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.

“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”

All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.

Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.

“That’s lower than people expect,” Dr. Gonzalez said.
 

How to boost screening

Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.

In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.

The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.

Other efforts to expand access to screening and treatment are underway.

In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.

“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.

Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.

“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”

Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.

“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.

“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”

Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.

dbrunk@mdedge.com

LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.

145132_Gonzalez_Stevan_A_web.jpg

That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.

About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”

Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
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At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.

“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.

More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.

Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.

From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).

Surprising exposure risk

The primary risk of transmission is through contaminated blood and the exposure through needles.

“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.

“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.

“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”

The duration of a person’s HCV infection drives the transmission.

“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”

One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)

HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.

“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
 

Weighing treatment options

The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.

“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”

All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.

Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.

“That’s lower than people expect,” Dr. Gonzalez said.
 

How to boost screening

Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.

In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.

The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.

Other efforts to expand access to screening and treatment are underway.

In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.

“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.

Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.

“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”

Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.

“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.

“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”

Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.

dbrunk@mdedge.com

The Food and Drug Administration has approved Agile Therapeutics’ levonorgestrel and ethinyl estradiol transdermal system (Twirla) for contraception in women whose body mass index is less than 30 kg/m² and for whom a combined hormonal contraceptive is appropriate.

FDA_icon3_web.jpg

Applied weekly to the abdomen, buttock, or upper torso (excluding the breasts), Twirla delivers a 30-mcg daily dose of ethinyl estradiol and 120-mcg daily dose of levonorgestrel.

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives, David Portman, MD, an obstetrician/gynecologist in Columbus, Ohio, and a primary investigator of the SECURE trial, said in a news release issued by the company.

Twirla was evaluated in “a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle,” Dr. Portman added.

As part of approval, the FDA will require Agile Therapeutics to conduct a long-term, prospective, observational postmarketing study to assess risks for venous thromboembolism and arterial thromboembolism in new users of Twirla, compared with new users of other combined hormonal contraceptives.

[embed:render:related:node:211286]

Twirla is contraindicated in women at high risk for arterial or venous thrombotic disease, including women with a BMI equal to or greater than 30 kg/m²; women who have headaches with focal neurologic symptoms or migraine with aura; and women older than 35 years who have any migraine headache.

Twirla also should be avoided in women who have liver tumors, acute viral hepatitis, decompensated cirrhosis, liver disease, or undiagnosed abnormal uterine bleeding. It also should be avoided during pregnancy; in women who currently have or who have history of breast cancer or other estrogen- or progestin-sensitive cancer; in women who are hypersensitivity to any components of Twirla; and in women who use hepatitis C drug combinations containing ombitasvir/paraparesis/ritonavir, with or without dasabuvir.

Because cigarette smoking increases the risk for serious cardiovascular events from combined hormonal contraceptive use, Twirla also is contraindicated in women older than 35 who smoke.

Twirla will contain a boxed warning that will include these risks about cigarette smoking and the serious cardiovascular events, and it will stipulate that Twirla is contraindicated in women with a BMI greater than 30 kg/m².

This article first appeared on Medscape.com.

The Food and Drug Administration has approved Agile Therapeutics’ levonorgestrel and ethinyl estradiol transdermal system (Twirla) for contraception in women whose body mass index is less than 30 kg/m² and for whom a combined hormonal contraceptive is appropriate.

FDA_icon3_web.jpg

Applied weekly to the abdomen, buttock, or upper torso (excluding the breasts), Twirla delivers a 30-mcg daily dose of ethinyl estradiol and 120-mcg daily dose of levonorgestrel.

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives, David Portman, MD, an obstetrician/gynecologist in Columbus, Ohio, and a primary investigator of the SECURE trial, said in a news release issued by the company.

Twirla was evaluated in “a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle,” Dr. Portman added.

As part of approval, the FDA will require Agile Therapeutics to conduct a long-term, prospective, observational postmarketing study to assess risks for venous thromboembolism and arterial thromboembolism in new users of Twirla, compared with new users of other combined hormonal contraceptives.

[embed:render:related:node:211286]

Twirla is contraindicated in women at high risk for arterial or venous thrombotic disease, including women with a BMI equal to or greater than 30 kg/m²; women who have headaches with focal neurologic symptoms or migraine with aura; and women older than 35 years who have any migraine headache.

Twirla also should be avoided in women who have liver tumors, acute viral hepatitis, decompensated cirrhosis, liver disease, or undiagnosed abnormal uterine bleeding. It also should be avoided during pregnancy; in women who currently have or who have history of breast cancer or other estrogen- or progestin-sensitive cancer; in women who are hypersensitivity to any components of Twirla; and in women who use hepatitis C drug combinations containing ombitasvir/paraparesis/ritonavir, with or without dasabuvir.

Because cigarette smoking increases the risk for serious cardiovascular events from combined hormonal contraceptive use, Twirla also is contraindicated in women older than 35 who smoke.

Twirla will contain a boxed warning that will include these risks about cigarette smoking and the serious cardiovascular events, and it will stipulate that Twirla is contraindicated in women with a BMI greater than 30 kg/m².

This article first appeared on Medscape.com.

The Food and Drug Administration has approved Agile Therapeutics’ levonorgestrel and ethinyl estradiol transdermal system (Twirla) for contraception in women whose body mass index is less than 30 kg/m² and for whom a combined hormonal contraceptive is appropriate.

FDA_icon3_web.jpg

Applied weekly to the abdomen, buttock, or upper torso (excluding the breasts), Twirla delivers a 30-mcg daily dose of ethinyl estradiol and 120-mcg daily dose of levonorgestrel.

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives, David Portman, MD, an obstetrician/gynecologist in Columbus, Ohio, and a primary investigator of the SECURE trial, said in a news release issued by the company.

Twirla was evaluated in “a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle,” Dr. Portman added.

As part of approval, the FDA will require Agile Therapeutics to conduct a long-term, prospective, observational postmarketing study to assess risks for venous thromboembolism and arterial thromboembolism in new users of Twirla, compared with new users of other combined hormonal contraceptives.

[embed:render:related:node:211286]

Twirla is contraindicated in women at high risk for arterial or venous thrombotic disease, including women with a BMI equal to or greater than 30 kg/m²; women who have headaches with focal neurologic symptoms or migraine with aura; and women older than 35 years who have any migraine headache.

Twirla also should be avoided in women who have liver tumors, acute viral hepatitis, decompensated cirrhosis, liver disease, or undiagnosed abnormal uterine bleeding. It also should be avoided during pregnancy; in women who currently have or who have history of breast cancer or other estrogen- or progestin-sensitive cancer; in women who are hypersensitivity to any components of Twirla; and in women who use hepatitis C drug combinations containing ombitasvir/paraparesis/ritonavir, with or without dasabuvir.

Because cigarette smoking increases the risk for serious cardiovascular events from combined hormonal contraceptive use, Twirla also is contraindicated in women older than 35 who smoke.

Twirla will contain a boxed warning that will include these risks about cigarette smoking and the serious cardiovascular events, and it will stipulate that Twirla is contraindicated in women with a BMI greater than 30 kg/m².

This article first appeared on Medscape.com.

Hepatitis C virus testing should be combined with HIV integrated care services among people who inject drugs (PWID), according to researchers reporting on a multisite randomized trial of nearly 12,000 HIV-infected individuals in India.

hepatitis_C_2_web.jpg

HCV antibody prevalence at these sites ranged from 7.2%-76.6%. Across six integrated care centers (ICCs), 5,263 clients underwent HCV testing, of whom 2,278 were newly diagnosed. At evaluation, PWID in ICC clusters were nearly four times more likely to report being tested for HCV than those in usual care clusters (adjusted prevalence ratio [aPR]: 3.69), according to the report by Sunil Suhas Solomon, MD, of Johns Hopkins University School of Medicine, Baltimore, and colleagues.

PWID in ICC clusters were also seven times more likely to be aware of their HCV status (aPR: 7.11; 95% confidence interval: 1.14, 44.3) and significantly more likely to initiate treatment, (aPR: 9.86; 95% CI: 1.52, 63.8), than individuals in usual care, the authors stated in their report published online ahead of press in the Journal of Hepatology.

“These data provide among the first empirical support of the benefits of integrating HCV testing with HIV prevention and treatment services for PWID. Over a short duration, we observed significant impact on community-level HCV testing and awareness of HCV status among PWID. While additional strategies might be required to improve population awareness levels, integration of HCV testing with HIV programs for PWID particularly given the high burden of HIV/HCV coinfection represents a critical first step,” the researchers concluded.

The study was funded by the National Institutes of Health and the Elton John AIDS Foundation. The authors reported that they had no relevant disclosures.

mlesney@mdedge.com

SOURCE: Solomon, SS et al. J Hepatol. 2019. doi.org/10.1016/j.jhep.2019.09.022.

Hepatitis C virus testing should be combined with HIV integrated care services among people who inject drugs (PWID), according to researchers reporting on a multisite randomized trial of nearly 12,000 HIV-infected individuals in India.

hepatitis_C_2_web.jpg

HCV antibody prevalence at these sites ranged from 7.2%-76.6%. Across six integrated care centers (ICCs), 5,263 clients underwent HCV testing, of whom 2,278 were newly diagnosed. At evaluation, PWID in ICC clusters were nearly four times more likely to report being tested for HCV than those in usual care clusters (adjusted prevalence ratio [aPR]: 3.69), according to the report by Sunil Suhas Solomon, MD, of Johns Hopkins University School of Medicine, Baltimore, and colleagues.

PWID in ICC clusters were also seven times more likely to be aware of their HCV status (aPR: 7.11; 95% confidence interval: 1.14, 44.3) and significantly more likely to initiate treatment, (aPR: 9.86; 95% CI: 1.52, 63.8), than individuals in usual care, the authors stated in their report published online ahead of press in the Journal of Hepatology.

“These data provide among the first empirical support of the benefits of integrating HCV testing with HIV prevention and treatment services for PWID. Over a short duration, we observed significant impact on community-level HCV testing and awareness of HCV status among PWID. While additional strategies might be required to improve population awareness levels, integration of HCV testing with HIV programs for PWID particularly given the high burden of HIV/HCV coinfection represents a critical first step,” the researchers concluded.

The study was funded by the National Institutes of Health and the Elton John AIDS Foundation. The authors reported that they had no relevant disclosures.

mlesney@mdedge.com

SOURCE: Solomon, SS et al. J Hepatol. 2019. doi.org/10.1016/j.jhep.2019.09.022.

Hepatitis C virus testing should be combined with HIV integrated care services among people who inject drugs (PWID), according to researchers reporting on a multisite randomized trial of nearly 12,000 HIV-infected individuals in India.

hepatitis_C_2_web.jpg

HCV antibody prevalence at these sites ranged from 7.2%-76.6%. Across six integrated care centers (ICCs), 5,263 clients underwent HCV testing, of whom 2,278 were newly diagnosed. At evaluation, PWID in ICC clusters were nearly four times more likely to report being tested for HCV than those in usual care clusters (adjusted prevalence ratio [aPR]: 3.69), according to the report by Sunil Suhas Solomon, MD, of Johns Hopkins University School of Medicine, Baltimore, and colleagues.

PWID in ICC clusters were also seven times more likely to be aware of their HCV status (aPR: 7.11; 95% confidence interval: 1.14, 44.3) and significantly more likely to initiate treatment, (aPR: 9.86; 95% CI: 1.52, 63.8), than individuals in usual care, the authors stated in their report published online ahead of press in the Journal of Hepatology.

“These data provide among the first empirical support of the benefits of integrating HCV testing with HIV prevention and treatment services for PWID. Over a short duration, we observed significant impact on community-level HCV testing and awareness of HCV status among PWID. While additional strategies might be required to improve population awareness levels, integration of HCV testing with HIV programs for PWID particularly given the high burden of HIV/HCV coinfection represents a critical first step,” the researchers concluded.

The study was funded by the National Institutes of Health and the Elton John AIDS Foundation. The authors reported that they had no relevant disclosures.

mlesney@mdedge.com

SOURCE: Solomon, SS et al. J Hepatol. 2019. doi.org/10.1016/j.jhep.2019.09.022.

A low percentage of mixed genotypes of hepatitis C virus (HCV) was found in a small study of recently infected HIV+ and HIV– men who have sex with men (MSM) according to a report by Thuy Nguyen, PhD, of the University of North Carolina, Chapel Hill, and colleagues published in the International Journal of Antimicrobial Agents.

Genes_DNA_4_web.jpg

The researchers assessed 58 HCV-infected individuals with a median age of 38.5 years, 50 of whom were HIV positive and 18 of whom were HIV negative. Most of the patients were MSM (85.3%), with the rest of unknown sexual orientation. HCV genotyping by Sanger found types GT1a, GT4d, GT3a, and GT2k infection in 47.1%, 41.2%, 8.8%, and 2.9% of the individuals.

After eliminating suspected contaminations, three patients (4.4%) were found with mixed GT infections All three patients were infected with HCV for the first time; two-thirds were coinfected with HIV. The mixed GTs comprised only GT4d and GT1a at different ratios. Mixed infections are potentially problematic when using direct-acting antiviral therapy without broad-spectrum activity, according to the researchers. In this case, however, all HCV patients achieved treatment success.

“From a public health perspective, the MSM population engaging in high-risk behaviors still requires special attention in terms of mixed infections compared with the general HCV-infected population with a regular monitoring of anti-HCV treatment response, particularly when pangenotypic treatment is not used,” the researchers concluded.

The study was funded by the French government; the authors reported having no conflicts.

mlesney@mdedge.com

SOURCE: Nguyen T et al. Int J Antimicrobial Agents. 2019. 54[4]:523-7.

A low percentage of mixed genotypes of hepatitis C virus (HCV) was found in a small study of recently infected HIV+ and HIV– men who have sex with men (MSM) according to a report by Thuy Nguyen, PhD, of the University of North Carolina, Chapel Hill, and colleagues published in the International Journal of Antimicrobial Agents.

Genes_DNA_4_web.jpg

The researchers assessed 58 HCV-infected individuals with a median age of 38.5 years, 50 of whom were HIV positive and 18 of whom were HIV negative. Most of the patients were MSM (85.3%), with the rest of unknown sexual orientation. HCV genotyping by Sanger found types GT1a, GT4d, GT3a, and GT2k infection in 47.1%, 41.2%, 8.8%, and 2.9% of the individuals.

After eliminating suspected contaminations, three patients (4.4%) were found with mixed GT infections All three patients were infected with HCV for the first time; two-thirds were coinfected with HIV. The mixed GTs comprised only GT4d and GT1a at different ratios. Mixed infections are potentially problematic when using direct-acting antiviral therapy without broad-spectrum activity, according to the researchers. In this case, however, all HCV patients achieved treatment success.

“From a public health perspective, the MSM population engaging in high-risk behaviors still requires special attention in terms of mixed infections compared with the general HCV-infected population with a regular monitoring of anti-HCV treatment response, particularly when pangenotypic treatment is not used,” the researchers concluded.

The study was funded by the French government; the authors reported having no conflicts.

mlesney@mdedge.com

SOURCE: Nguyen T et al. Int J Antimicrobial Agents. 2019. 54[4]:523-7.

A low percentage of mixed genotypes of hepatitis C virus (HCV) was found in a small study of recently infected HIV+ and HIV– men who have sex with men (MSM) according to a report by Thuy Nguyen, PhD, of the University of North Carolina, Chapel Hill, and colleagues published in the International Journal of Antimicrobial Agents.

Genes_DNA_4_web.jpg

The researchers assessed 58 HCV-infected individuals with a median age of 38.5 years, 50 of whom were HIV positive and 18 of whom were HIV negative. Most of the patients were MSM (85.3%), with the rest of unknown sexual orientation. HCV genotyping by Sanger found types GT1a, GT4d, GT3a, and GT2k infection in 47.1%, 41.2%, 8.8%, and 2.9% of the individuals.

After eliminating suspected contaminations, three patients (4.4%) were found with mixed GT infections All three patients were infected with HCV for the first time; two-thirds were coinfected with HIV. The mixed GTs comprised only GT4d and GT1a at different ratios. Mixed infections are potentially problematic when using direct-acting antiviral therapy without broad-spectrum activity, according to the researchers. In this case, however, all HCV patients achieved treatment success.

“From a public health perspective, the MSM population engaging in high-risk behaviors still requires special attention in terms of mixed infections compared with the general HCV-infected population with a regular monitoring of anti-HCV treatment response, particularly when pangenotypic treatment is not used,” the researchers concluded.

The study was funded by the French government; the authors reported having no conflicts.

mlesney@mdedge.com

SOURCE: Nguyen T et al. Int J Antimicrobial Agents. 2019. 54[4]:523-7.

Kidneys from donors with hepatitis C virus (HCV) infection function well despite adverse quality assessment and are a valuable resource for transplantation candidates independent of HCV status, according to the findings of a large U.S. registry study.

Kidney_illustration_web.jpg

A total of 260 HCV-viremic kidneys were transplanted in the first quarter of 2019, with 105 additional viremic kidneys being discarded, according to a report in the Journal of the American Society of Nephrology by Vishnu S. Potluri, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

Donor HCV viremia was defined as an HCV nucleic acid test–positive result reported to the Organ Procurement and Transplantation Network (OPTN). Donors who were HCV negative in this test were labeled as HCV nonviremic. Kidney transplantation recipients were defined as either HCV seropositive or seronegative based on HCV antibody testing.

During the first quarter of 2019, 74% of HCV-viremic kidneys were transplanted into seronegative recipients, which is a major change from how HCV-viremic kidneys were allocated a few years ago, according to the researchers. The results of small trials showing the benefits of such transplantations and the success of direct-acting antiviral therapy (DAA) on clearing HCV infections were indicated as likely responsible for the change.

HCV-viremic kidneys had similar function, compared with HCV-nonviremic kidneys, when matched on the donor elements included in the Kidney Profile Donor Index (KDPI), excluding HCV, they added. In addition, the 12-month estimated glomerular filtration rate (eGFR) was similar between the seropositive and seronegative recipients, respectively 65.4 and 71.1 mL/min per 1.73 m² (P = .05), which suggests that recipient HCV serostatus does not negatively affect 1-year graft function using HCV-viremic kidneys in the era of DAA treatments, according to the authors.

Also, among HCV-seropositive recipients of HCV-viremic kidneys, seven (3.4%) died by 1 year post transplantation, while none of the HCV-seronegative recipients of HCV-viremic kidneys experienced graft failure or death.

“These striking results provide important additional evidence that the KDPI, with its current negative weighting for HCV status, does not accurately assess the quality of kidneys from HCV-viremic donors,” the authors wrote.

“HCV-viremic kidneys are a valuable resource for transplantation. Disincentives for accepting these organs should be addressed by the transplantation community,” Dr. Potluri and colleagues concluded.

This work was supported in part by the Health Resources and Services Administration of the U.S. Department of Health & Human Services. The various authors reported grant funding and advisory board participation with a number of pharmaceutical companies.

mlesney@mdedge.com

SOURCE: Potluri VS et al. J Am Soc Nephrol. 2019;30:1939-51.

Kidneys from donors with hepatitis C virus (HCV) infection function well despite adverse quality assessment and are a valuable resource for transplantation candidates independent of HCV status, according to the findings of a large U.S. registry study.

Kidney_illustration_web.jpg

A total of 260 HCV-viremic kidneys were transplanted in the first quarter of 2019, with 105 additional viremic kidneys being discarded, according to a report in the Journal of the American Society of Nephrology by Vishnu S. Potluri, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

Donor HCV viremia was defined as an HCV nucleic acid test–positive result reported to the Organ Procurement and Transplantation Network (OPTN). Donors who were HCV negative in this test were labeled as HCV nonviremic. Kidney transplantation recipients were defined as either HCV seropositive or seronegative based on HCV antibody testing.

During the first quarter of 2019, 74% of HCV-viremic kidneys were transplanted into seronegative recipients, which is a major change from how HCV-viremic kidneys were allocated a few years ago, according to the researchers. The results of small trials showing the benefits of such transplantations and the success of direct-acting antiviral therapy (DAA) on clearing HCV infections were indicated as likely responsible for the change.

HCV-viremic kidneys had similar function, compared with HCV-nonviremic kidneys, when matched on the donor elements included in the Kidney Profile Donor Index (KDPI), excluding HCV, they added. In addition, the 12-month estimated glomerular filtration rate (eGFR) was similar between the seropositive and seronegative recipients, respectively 65.4 and 71.1 mL/min per 1.73 m² (P = .05), which suggests that recipient HCV serostatus does not negatively affect 1-year graft function using HCV-viremic kidneys in the era of DAA treatments, according to the authors.

Also, among HCV-seropositive recipients of HCV-viremic kidneys, seven (3.4%) died by 1 year post transplantation, while none of the HCV-seronegative recipients of HCV-viremic kidneys experienced graft failure or death.

“These striking results provide important additional evidence that the KDPI, with its current negative weighting for HCV status, does not accurately assess the quality of kidneys from HCV-viremic donors,” the authors wrote.

“HCV-viremic kidneys are a valuable resource for transplantation. Disincentives for accepting these organs should be addressed by the transplantation community,” Dr. Potluri and colleagues concluded.

This work was supported in part by the Health Resources and Services Administration of the U.S. Department of Health & Human Services. The various authors reported grant funding and advisory board participation with a number of pharmaceutical companies.

mlesney@mdedge.com

SOURCE: Potluri VS et al. J Am Soc Nephrol. 2019;30:1939-51.

Kidneys from donors with hepatitis C virus (HCV) infection function well despite adverse quality assessment and are a valuable resource for transplantation candidates independent of HCV status, according to the findings of a large U.S. registry study.

Kidney_illustration_web.jpg

A total of 260 HCV-viremic kidneys were transplanted in the first quarter of 2019, with 105 additional viremic kidneys being discarded, according to a report in the Journal of the American Society of Nephrology by Vishnu S. Potluri, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

Donor HCV viremia was defined as an HCV nucleic acid test–positive result reported to the Organ Procurement and Transplantation Network (OPTN). Donors who were HCV negative in this test were labeled as HCV nonviremic. Kidney transplantation recipients were defined as either HCV seropositive or seronegative based on HCV antibody testing.

During the first quarter of 2019, 74% of HCV-viremic kidneys were transplanted into seronegative recipients, which is a major change from how HCV-viremic kidneys were allocated a few years ago, according to the researchers. The results of small trials showing the benefits of such transplantations and the success of direct-acting antiviral therapy (DAA) on clearing HCV infections were indicated as likely responsible for the change.

HCV-viremic kidneys had similar function, compared with HCV-nonviremic kidneys, when matched on the donor elements included in the Kidney Profile Donor Index (KDPI), excluding HCV, they added. In addition, the 12-month estimated glomerular filtration rate (eGFR) was similar between the seropositive and seronegative recipients, respectively 65.4 and 71.1 mL/min per 1.73 m² (P = .05), which suggests that recipient HCV serostatus does not negatively affect 1-year graft function using HCV-viremic kidneys in the era of DAA treatments, according to the authors.

Also, among HCV-seropositive recipients of HCV-viremic kidneys, seven (3.4%) died by 1 year post transplantation, while none of the HCV-seronegative recipients of HCV-viremic kidneys experienced graft failure or death.

“These striking results provide important additional evidence that the KDPI, with its current negative weighting for HCV status, does not accurately assess the quality of kidneys from HCV-viremic donors,” the authors wrote.

“HCV-viremic kidneys are a valuable resource for transplantation. Disincentives for accepting these organs should be addressed by the transplantation community,” Dr. Potluri and colleagues concluded.

This work was supported in part by the Health Resources and Services Administration of the U.S. Department of Health & Human Services. The various authors reported grant funding and advisory board participation with a number of pharmaceutical companies.

mlesney@mdedge.com

SOURCE: Potluri VS et al. J Am Soc Nephrol. 2019;30:1939-51.