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

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 138; no. 1; p. 108
• Main Authors: Rumi, Maria Grazia, Aghemo, Alessio, Prati, Gian Maria, D'Ambrosio, Roberta, Donato, Maria Francesca, Soffredini, Roberta, Del Ninno, Ersilio, Russo, Antonio, Colombo, Massimo
• Format: Journal Article
• Language: English
• Published: United States 01.01.2010
• Subjects: Adolescent; Adult; Aged; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Drug Resistance, Viral; Drug Therapy, Combination; Female; Follow-Up Studies; Genotype; Hepacivirus - drug effects; Hepacivirus - genetics; Hepatitis C, Chronic - drug therapy; Humans; Interferon-alpha - administration & dosage; Interferon-alpha - adverse effects; Logistic Models; Male; Middle Aged; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Recombinant Proteins; Ribavirin - administration & dosage; Ribavirin - adverse effects; Young Adult
• ISSN: 1528-0012
• DOI: 10.1053/j.gastro.2009.08.071

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. Treatment-naïve 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. 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). Although the 2 regimens showed a similar safety profile, the PegIFNalpha2a-based treatment yielded significantly more SVR than PegIFNalpha2b.