ANCHOR Study Finds High Adherence Rate in Patients With Hepatitis C Who Inject Opioids

Research presented at The Liver Meeting, held by the American Association for the Study of Liver Diseases, found high rates of adherence, treatment completion, and sustained virologic response (SVR) among patients infected with the hepatitis C virus (HCV) who inject drugs. These findings, from a study conducted at a single site, led authors to recommend inclusion of this subset of patients in HCV treatment programs.

HCV transmission occurs through contact with an infected person’s blood, which makes injectable drug users highly susceptible to the virus. Unfortunately, the assumption that this subset of patients may not adhere to treatment plans leads to their exclusion from HCV clinical trials.

“Many insurance companies impose restrictions requiring treatment of or abstinence from drugs and alcohol prior to initiation of HCV medication,” said study author Elana Rosenthal, MD, who is co-director of DC PFAP Hepatitis Clinical Research Program, University of Maryland, in a statement. “We wanted to specifically evaluate treatment of the highest risk population, people with ongoing injection drug use, to evaluate if they could be cured with standard treatment using direct-acting antivirals.”

Of the 169 patients who were screened, 97 were enrolled, a majority of whom were male (75%) and black (93%). Half of the enrollees had unstable housing (51%) and 57% reported that they took a daily injection of opioids.

The ANCHOR trial was designed to evaluate HCV treatment in patients who inject drugs with chronic HCV, opioid use disorder, and injectable drug users within 3 months. Participants were treated with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks, with medication dispensed in 28 pill bottles.

Using pill bottles as an indicator of adherence, by week 24, 60 (91%) of enrollees received the second bottle of SOF/VEL and 58 (88%) received the third bottle before running out. A small fraction (8 patients) had an interruption in their treatment of between 3 and 15 days.

In total, 2 (3%) patients received 4 weeks of treatment, 2 (3%) received 8 weeks, 3 (5%) received between 8 and 12 weeks, and 59 (89%) received 12 weeks of treatment. Further, of the patients who completed the 12-week treatment cycle, 28 (48%) finished 1 to 7 days after the anticipated end of treatment, 9 (16%) finished between 8 and 14 days late, and 9 (16%) finished more than 14 days late; 52 (90%) of the 58 patients who made it to the week 24 visit had attained SVR.

The analysis showed:

• Association between SVR and HCV viral load less than 200 at week 4 (P = .004)
• Association between SVR and taking 12 weeks of treatment (P = .003)

Additionally, receiving the second bottle before pills running out had a significant association with SVR.

Highlighting that people who inject drugs, despite imperfect adherence, can achieve SVR at comparable rates to those who do not use drugs, Rosenthal disproved the exclusion of these individuals from HCV treatment.

“In fact, people who inject drugs should represent a unique high-priority population, because injection drug use remains the primary reason for ongoing HCV transmission in the U.S. Therefore, treatment of people who inject drugs will help prevent new cases of HCV,” he said.

Reference

Kattakuzhy S, Mathur P, Gross C, et al. High SVR in PWID with HCV despite imperfect medication adherence: data from the anchor study. Hepatology. 2018;68(S1). doi: 10.1002/hep.30256.