Peer Reviewed Study

Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study

November 19, 2020
National Library of Medicine
Brooks KM, Castillo-Mancilla JR, Morrow M, MaWhinney S, Rowan SE, Wyles D, Blum J, Huntley R, Salah LM, Tehrani A, Bushman LR, Anderson PL, Kiser JJ
Managing Medication Adherence to Improve Outcomes and Quality Metrics


Background: Hepatitis C virus treatment in persons who use drugs (PWUD) is often withheld due to adherence and reinfection concerns. In this study, we report treatment outcomes, technology-based adherence data, and adherence predictors in PWUD and/or alcohol.

Methods: INCLUD was a prospective, open-label study of ledipasvir/sofosbuvir for 12 weeks in PWUD aged 18-70 years. Participants were randomized to wireless (wirelessly observed therapy) or video-based directly observed therapy (vDOT). Drug use was assessed every 2 weeks. Sustained virologic response (SVR) was examined by intention-to-treat and as-treated. Factors associated with missing ≥1 dose(s) between visits were examined using generalized linear models.

Results: Sixty participants received ≥1 ledipasvir/sofosbuvir dose (47 human immunodeficiency virus [HIV]/hepatitis C virus [HCV], 13 HCV only; 78% male; 22% black; 25% cirrhotic). Substance use occurred at 94% of person-visits: 60% marijuana, 56% alcohol, 37% methamphetamine, 22% opioids, 17% cocaine, and 20% injection drug use. The SVR by intention-to-treat was 86.7% (52 of 60) and as-treated was 94.5% (52 of 55). Confirmed failures included 1 relapse, 1 reinfection, and 1 unknown (suspected reinfection). Median total adherence was 96% (interquartile range [IQR], 85%-100%; range, 30%-101%), and between-visit adherence was 100% (IQR, 86%-100%; range, 0%-107%). The odds of missing ≥1 dose between visits increased with HIV coinfection (2.94; 95% confidence interval [CI], 1.37-6.32; P = .006), black race (4.09; 95% CI, 1.42-11.74; P = .009), methamphetamine use (2.51; 95% CI, 1.44-4.37; P = .0.001), and cocaine use (2.12; 95% CI, 1.08-4.18; P = .03) and decreased with marijuana use (0.34; 95% CI, 0.17-0.70; P = .003) and vDOT (0.43; 95% CI, 0.21-0.87; P = .02).

Conclusions: Persons who use drugs achieved high SVR rates with high, but variable, ledipasvir/sofosbuvir adherence using technology-based methods. These findings support efforts to expand HCV treatment in PWUD.

Keywords: HIV; active drug use; alcohol; hepatitis C; ledipasvir/sofosbuvir.

© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

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Medication Adherence

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