Efficacy of Response-Guided Pegylated Interferon and Ribavirin Therapy for People who Inject Drugs with HCV Genotype 2/3 Infection: The ACTIVATE Study

Author: Grebely J, Dalgard O, Conway B, Foster G, Bruggmann P, Hajarizadeh B, Backmund M, Robaeys G, Swan T, Amin J, Marks P, Quiene S, Weltman M, Shaw D, Dunlop, Hellard M, Bruneau J, Bourgeois S, Staehelin C, and Dore G on behalf of the ACTIVATE Study Group

Theme: Clinical Research Year: 2015

Introduction: Despite guidelines advocating for HCV treatment among PWID, treatment uptake is low. The aim of this study was to evaluate response-guided pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) treatment for chronic HCV genotypes 2/3 (G2/3) among recent PWID.

Methods: Participants with chronic HCV G2/3 and recent injecting drug use (previous 12 weeks) or receiving opioid substitution treatment (OST) were recruited between 2012 and 2014. Participants received directly observed PEG-IFN (1.5 µg/kg/week) and self-administered RBV (800-1400 mg daily, weight-based). Participants with a rapid virological response (RVR) received 12 weeks (shortened duration) and those without RVR received 24 weeks (standard duration) therapy. The primary endpoint was sustained virological response at 12 weeks (SVR12) by intention to treat.

Results: 93 participants initiated treatment (mean age 42 years; 82% male; 87% HCV G3), with 25% (n=23) receiving OST with no recent injecting, 17% (n=16) receiving OST with recent injecting, and 58% (n=58%) not receiving OST with recent injecting. Sixty-six percent (n=61) achieved RVR and received shortened treatment, while 28% (n=26) did not achieve RVR and received standard treatment. SVR12 was 62% (58/93). Therapy was discontinued prior to week four in 6% (n=6). SVR12 was 79% (48/61) in those with RVR (shortened treatment) compared to 38% (10/26) in those without RVR (standard treatment). SVR was similar among OST non-injecting, OST injecting and non-OST injecting groups (68% vs. 63% vs. 86%, P=0.446). In multivariate analyses, RVR was the only factor associated with SVR (OR=7.51; 95% CI: 2.38, 23.73; P<0.001). Conclusion: Among PWID with chronic HCV G2/3, on-treatment RVR allowed shortened treatment duration and remained a strong predictor of SVR. Injecting drug use at baseline was not associated with reduced response to therapy. These data suggest that among PWID with chronic HCV G2/3 and an RVR, shortened PEG-IFN/RBV treatment may be a feasible strategy.

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