MOAB0103 - Oral Abstract
Interferon-free 3 DAA plus ribavirin regimen in HCV genotype 1-infected patients on methadone or buprenorphine
Presented by Daniel Cohen (United States).
J. Lalezari1, J.G. Sullivan2, P. Varunok3, E. Galen4, K.V. Kowdley5, V. Rustgi6, H. Aguilar7, F. Felizarta8, M. King9, D. Cohen9
1Quest Clinical Research, San Francisco, United States, 2Parkway Medical Center, Birmingham, United States, 3Premier Medical Group of the Hudson Valley, PC, Poughkeepsie, United States, 4Northwest Gastroenterology Clinic, Portland, United States, 5Digestive Disease Institute, Virginia Mason Medical Center, Seattle, United States, 6Metropolitan Research, Fairfax, United States, 7Louisiana Research Center, LLC, Shreveport, United States, 8Private Practice, Bakersfield, United States, 9AbbVie Inc., North Chicago, United States
Background: ABT-450 is an HCV NS3/4A protease inhibitor (dosed with ritonavir 100mg, ABT-450/r) identified by AbbVie and Enanta. ABT-267 is an NS5A inhibitor, and ABT-333 is an NS5B RNA polymerase inhibitor. This 3D regimen, dosed with ribavirin (RBV) in treatment-naïve and -experienced HCV-infected genotype 1 (GT1) patients, has demonstrated SVR12 rates of 96% after 12 weeks of treatment. We evaluated the safety and efficacy of 3D+RBV in HCV-infected patients receiving chronic opioid replacement therapy, a challenging population with a high prevalence of HCV.
Methods: Non-cirrhotic patients with chronic HCV GT1 infection who were on stable methadone or buprenorphine +/- naloxone therapy were enrolled in this open-label study. Patients were treated for 12 weeks with co-formulated ABT-450/r/267 (2 tabs QD), ABT-333 (1 tab BID), and weight-based RBV (3D+RBV). The percentage of patients achieving SVR12 (HCV RNA < LLOQ 12 weeks post-treatment) was assessed in an intent-to-treat analysis.
Results: 38 patients were enrolled (19 on methadone, 19 on buprenorphine). Mean age was 48.2 years, 66% were male, 95% were treatment-naïve, 84% had GT1a infection, and 68% had IL28b non-CC genotype. One patient prematurely discontinued due to serious adverse events unrelated to study drug (cerebrovascular accident and sarcoma). The remaining 37 subjects (97.4%) all achieved SVR12; complete data through post-treatment week 24 will be presented. There were no virologic failures. The most frequent adverse events were nausea (50%), fatigue (47.4%), and headache (31.6%); 8 patients experienced hemoglobin < 10 g/dL while on treatment, which was managed with RBV dose reduction. No dose adjustments of methadone or buprenorphine were reported.
Conclusions: Among patients on stable methadone or buprenorphine therapy, the 3D+RBV regimen was well tolerated and achieved an SVR12 rate of 97.4%.
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