Pegylated interferon-a2b plus rlbavirin: an efficacious and well-tolerated treatment regimen for patients with hepatitis C virus related historically proven cirrhosis

Background: Little is known about the efficacy, safety and tolerability of pegylated interferon plus ribavirin treatment in patients with chronic hepatitis C virus (HCV) infection and histologically proven fully established cirrhosis. We aimed here to evaluate the safety of this regimen in such patients and to identify baseline and on-treatment predictors of a sustained virological response (SVR). Methods: Patients with histologically proven, HCV-lnduced cirrhosis were randomized to receive pegylated interferon-a2b (PEG-IFN-a2b; 1.0 kg/kg/week, n=56; group A) or recombinant interferon-a2b (IFN-a2b; 3 million IU three times/week, n=36; group B), each in combination with a weight-based dose of ribavirin (800-1,200 mg/day) for up to 48 weeks. The primary endpoint of the study was the assessment of SVR, defined as undetectable HCV RNA 24 weeks after treatment cessation. Results: Overall, 40% (37/93) of patients attained SVR: 44% (25/57) in group A and 33% (12/36) in group B (P=0.31). SVR rates were significantly higher in genotype 2/3 patients than in genotype 1 patients (69% versus 25%; P