Efficacy and safety of peginterferon α-2a (40 kD) plus ribavirin among patients with chronic hepatitis C and earlier treatment failure to interferon and ribavirin: an open-label study in central and Eastern Europe

Methods: HCV genotype 1 patients previously treated with conventional interferon with or without ribavirin were assigned to 48 weeks of treatment with peginterferon alfa-2a (40KD) 180 mcg/week plus ribavirin (recommended dose 1000/1200 mg/day) in this open-label trial conducted in Central and Eastern Europe. The primary efficacy endpoint was sustained virological response (SVR, HCV RNA <50 IU/mL) after 24 weeks of untreated follow-up. Early virological response (EVR) was defined as undetectable HCV RNA or minimally 2-log drop at week 12. Results: 154/203 (76%) treatment-experienced genotype 1 patients completed treatment. Overall, 113 patients (56%) achieved an EVR, 107 (53%) had an end-of-treatment response and 63 patients (31%) achieved an SVR (including 38% [40/105] of those with prior breakthrough or relapse and 24% [21/88] of those with prior non-response). Among patients with an EVR 47% (53/113) achieved an SVR (positive predictive value = 47%), compared with 3% (1/34) of patients without EVR.