Injection Drug Users With HCV Still Able to Achieve Viral Remission

People who inject drugs who are infected with hepatitis C virus can achieve sustained viral response, despite imperfect adherence, according to the results of a new trial.

Although they are at high risk of hepatitis C virus infection and transmission, people who inject drugs tend to be excluded from treatment and coverage of treatment by health insurance because of concerns over adherence to therapy. As this population is most urgently in need of treatment, a team of investigators, led by Elana Rosenthal, MD, assistant professor of medicine in the Division of Clinical Care and Research, at the Institute of Human Virology, of the University of Maryland School of Medicine, in Baltimore, Maryland, set out to evaluate adherence in this population and determine if people who inject drugs are able to achieve cure of hepatitis C virus infection.

For the open-label, nonrandomized observational study—the ANCHOR study (NCT03221309)—Rosenthal and her team evaluated a model of care for the treatment of hepatitis C virus infection in people who inject drugs with chronic hepatitis C virus infection. All patients in the trial are treated with direct-acting antivirals (sofosbuvir/velpatasvir [SOF/VEL] for 12 weeks, dispensed monthly in 28-pill bottles) and are also offered pre-exposure prophylaxis for HIV prevention, as well as buprenorphine for treatment of opioid use disorder when clinically indicated, according to the study design.

A total of 160 patients were screened for the trial and 100 were enrolled. The majority of the patients were male (n = 76, 76%), with a median age of 57 years (interquartile range 53-62 years), black (n = 93, 93%) and about half (n = 51, 51%) were unstably housed. More than half (n = 58, 58%) reported daily injection drug use.

Three of the participants were infected with HIV and all 3 were not on treatment for HIV when they started treatment for their hepatitis C virus coinfection. According to Rosenthal, those patients were linked with care for their HIV infection. Two of the patients did initiate treatment for HIV, and although 1 did not, his CD4 count was >500c/mL.

“People who have HIV and hepatitis C virus coinfection and in HIV care had already been preferentially treated early on [for their hepatitis C virus coinfection],” Rosenthal explained. “The coinfected people that we saw were not in HIV care. Some of our patients had very low CD4 counts and so we prioritized HIV treatment in those patients.”

After 24 weeks of treatment, Rosenthal and her team found that even with imperfect adherence to treatment, the majority of the participants in the study were able to achieve cure, and the majority of the participants had completed all 3 bottles of the treatment (n = 87, 87%). Twenty-one patients had completed the treatment on time (at week 12) and 46 patients completed treatment after week 12.

The team found that having a suppressed viral load (<200 IU/mL) at week 4, was significantly associated with achieving sustained viral response, and at week 4, about 84 patients had achieved this goal. Interestingly, an interruption in treatment did not impact their sustained viral response. Furthermore, although completing the full course of treatment (3 bottles) was associated with sustained viral response (n = 87), so was completing 2 or more bottles (n = 7). Those participants who completed less than 2 bottles did not achieve sustained viral response (n = 6).

Thirteen participants had an interruption in treatment at varying time points in the study period, and these ranged from 3 days to 70 days.

“The most surprising result we had was the number of patients who cured, despite significant nonadherence,” Rosenthal said. “I had 1 patient who completed his medication 5 weeks after week 12, and he still cured. I had a patient who disappeared for 8 weeks and then came back to treatment. He cured. I had a patient with a 70-day interruption. He cured.”

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