Portal de Periódicos da CAPES

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

2020; Oxford University Press; Volume: 8; Issue: 1 Linguagem: Inglês

10.1093/ofid/ofaa564

2328-8957

Kristina M. Brooks, José Castillo‐Mancilla, Mary Morrow, Samantha MaWhinney, Sarah E. Rowan, David Wyles, Joshua Blum, Ryan Huntley, Lana M. Salah, Arya Tehrani, Lane R. Bushman, Peter L. Anderson, Jennifer J. Kiser,

HIV/AIDS Research and Interventions

Abstract 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.