Postpartum Treatment for Chronic Hepatitis C Virus Among People With Opioid Use Disorder: A Prospective Pilot Clinical Trial.

ABSTRACT

OBJECTIVE: The objective of this study was to evaluate the feasibility and acceptability of postpartum hepatitis C virus (HCV) treatment integrated within a substance use treatment program for pregnant and postpartum people with opioid use disorder (OUD). METHODS: We conducted a prospective pilot clinical trial of sofosbuvir/velpatasvir (SOF/VEL) treatment among postpartum people with OUD and HCV. Feasibility outcomes included rates of HCV treatment utilization and completion, medication adherence, and sustained virologic response 12 weeks after treatment completion (SVR12). Acceptability was measured through self-reported adverse effects and medication adherence. RESULTS: From January 2018 to August 2021, 164 pregnant people received care for OUD at the study site. Among those, 64 (39.0%) were HCV antibody positive and 45 (27.4%) had active HCV infection. Among 45 eligible patients, 32 (71.1%) enrolled and 21 (46.7%) initiated HCV treatment. Of 21 participants who initiated treatment, 16 (76.2%) completed the SOF/VEL treatment, and 11 (52.4%) completed the SVR12. All participants who completed treatment were cured. Common reasons for dropout during the HCV clinical care cascade were OUD treatment discontinuation, illicit substance use recurrence, and lost to follow-up. Participants reported high satisfaction with HCV treatment, including minimal adverse effects, and no HCV treatment concerns. CONCLUSIONS: Nearly half of pregnant people with HCV initiated postpartum treatment within an integrated care model of HCV treatment within a substance use treatment program. Postpartum SOF/VEL was efficacious, tolerable, and acceptable. Despite this, postpartum HCV treatment among people with OUD remains challenging, and many barriers remain.