Non-adherence to LDV/SOF did not predict SVR in a randomized controlled trial of HIV/HCV coinfected persons who use drugs.

BACKGROUND Eliminating Hepatitis C Virus (HCV) will require effective treatment delivery to persons with substance use disorders (SUDs). We evaluated the relationship between ledipasvir/sofosbuvir treatment persistence (receiving 84 tablets), adherence, and sustained virologic response (SVR) in persons with HIV/HCV coinfection. METHODS Of the 144 participants with HIV/HCV and SUDs, 110 initiated a 12-week treatment course under one of three conditions (usual care, peer mentors, and cash incentives). We used self-report, pharmacy pill counts, and expected date of refill to examine adherence. Persistent participants were categorized as high adherence (taking ≥90% of doses) or low adherence (taking <90% of doses). RESULTS Most participants persisted on treatment after initiation (n=105), with 95% (n=100) achieving SVR. One-third (34%) of participants had moderate/heavy alcohol use by the biomarker phosphatidylethanol (PEth ≥50 ng/mL), and 44% had urine toxicology positive for cocaine or heroin at enrollment. The proportion of persons with high adherence was 72% (n=76) and low adherence, 28%. Although low adherence was associated with moderate/heavy alcohol use by PEth (RR 2.77, 95% CI 1.50-5.12), SVR did not vary according to adherence (p=0.702), and most participants (97%) with low adherence achieved SVR. CONCLUSION Treatment persistence led to high SVR rates among persons with HIV/HCV, despite imperfect adherence and SUDs.