Randomized trial of interferon beta-1a with or without ribavirin in Asian patients with chronic hepatitis C

Abstract

The standard of care for chronic hepatitis C virus (HCV) infection, pegylated interferon (IFN) alpha plus ribavirin, results in a sustained virologic response (SVR) in approximately 50%-60% of patients. IFN beta is a potential alternative to IFN alpha. The aim of this study was to investigate the efficiency and durability of IFN beta and its combination with ribavirin in the naïve setting of chronic hepatitis C in Asian patients. In the initial randomized, double-blind phase, patients with chronic hepatitis C (n = 257) received 12 weeks of treatment with IFN beta-1a, 44 mug subcutaneously 3 times weekly, or a placebo. In the subsequent open-label phase, placebo nonresponders received 24 weeks of treatment with IFN beta-1a plus ribavirin, whereas patients receiving IFN beta-1a monotherapy received an additional 12 weeks of therapy. The primary outcome variable was SVR, which was defined as negative HCV RNA after weeks 24 and 48. A total of 34 of 128 patients (26.6%) receiving IFN beta-1a achieved an SVR versus 0 of 129 patients (0%) receiving the placebo (P < 0.001). In the IFN beta-1a/ribavirin group, 73 of 127 patients (57.5%) achieved an SVR [P < 0.001 versus IFN beta-1a; the adjusted odds ratio was 4.54 (95% confidence interval: 2.53, 8.13)]. In HCV genotype 1 patients, 37 of 80 patients (46.3%) treated with IFN beta-1a/ribavirin achieved an SVR versus 19 of 85 patients (22.4%) treated with IFN beta-1a (P = 0.001). IFN beta-1a produced a clear antiviral effect in Asian patients with chronic HCV infection. The addition of ribavirin to IFN beta-1a significantly increased the proportion of patients who achieved an SVR versus IFN beta-1a monotherapy.