Randomized Study of Peginterferon-alpha2a Plus Ribavirin vs Peginterferon-alpha2b Plus Ribavirin in Chronic Hepatitis C

Background & Aims Ribavirin (RBV) combined with either pegylated interferon (PegIFN) \u3b12a or PegIFN\u3b12b is the standard of care for chronic hepatitis C virus (HCV) infection. Due to the lack of head-to-head studies, the 2 PegIFNs have not been directly compared. The endpoints of our study were safety and antiviral efficacy of the 2 regimens. Methods Treatment-na\uefve patients with chronic hepatitis C were randomly (1:1) assigned after stratification for HCV genotype to receive either 1.5 mcg/Kg/week PegIFN\u3b12b plus RBV 800\u20131200 mg/day or 180 mcg/week PegIFN\u3b12a plus RBV 800\u20131200 mg/day for 24 or 48 weeks according to HCV genotype. The study was powered to detect a difference of at least 10% in safety and efficacy of the 2 regimens. Results The 212 patients on PegIFN\u3b12a and the 219 patients on PegIFN\u3b12b had similar baseline characteristics, including cirrhosis (20% vs 18%, respectively). By intention to treat, the 2 groups showed similar rates of treatment-related serious adverse events (1% vs 1%, respectively) and drop out rates for adverse effects (7% vs 6%, respectively). Overall, sustained virologic response (SVR) rate was higher in PegIFN\u3b12a than in PegIFN\u3b12b patients (66% vs 54%, respectively, P = .02), being 48% vs 32% in the 222 HCV-1 and -4 patients (P = .04), and 96% vs 82%, respectively, in the 143 HCV-2 patients (P = .01). PegIFN\u3b12a independently predicted SVR in the logistic regression analysis (odds ratio, 1.88; 95% confidence interval: 1.20\u20132.96). Conclusions Although the 2 regimens showed a similar safety profile, the PegIFN\u3b12a-based treatment yielded significantly more SVR than PegIFN\u3b12b