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Randomized study of peginterferon-alpha2a plus ribavirin vs peginterferon-alpha2b plus ribavirin in chronic hepatitis C.

Author(s): Rumi MG, Aghemo A, Prati GM, D'Ambrosio R, Donato MF, Soffredini R, Del Ninno E, Russo A, Colombo M

Affiliation(s): AM Migliavacca Center for Liver Disease, First Division of Gastroenterology, Fondazione IRCCS Maggiore Hospital, Mangiagalli e Regina Elena, Universita degli Studi di Milano, Milan, Italy. mariagrazia.rumi@unimi.it

Publication date & source: 2010-01, Gastroenterology., 138(1):108-15. Epub 2009 Sep 18.

Publication type: Comparative Study; Randomized Controlled Trial

BACKGROUND & AIMS: Ribavirin (RBV) combined with either pegylated interferon (PegIFN) alpha2a or PegIFNalpha2b 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-naive patients with chronic hepatitis C were randomly (1:1) assigned after stratification for HCV genotype to receive either 1.5 mcg/Kg/week PegIFNalpha2b plus RBV 800-1200 mg/day or 180 mcg/week PegIFNalpha2a plus RBV 800-1200 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 PegIFNalpha2a and the 219 patients on PegIFNalpha2b 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 PegIFNalpha2a than in PegIFNalpha2b 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). PegIFNalpha2a independently predicted SVR in the logistic regression analysis (odds ratio, 1.88; 95% confidence interval: 1.20-2.96). CONCLUSIONS: Although the 2 regimens showed a similar safety profile, the PegIFNalpha2a-based treatment yielded significantly more SVR than PegIFNalpha2b. Copyright 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

Page last updated: 2010-10-05

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