A randomized, double-blind trial comparing pegylated interferon alfa-2b tointerferon alfa-2b as initial treatment for chronic hepatitis C

This international, randomized, active-controlled, parallel-group, double-b lind dose-finding study compared peginterferon alfa-2b (PegIntron (TM)) to interferon alfa-2b for the initial treatment of compensated chronic hepatit is C. We randomly assigned 1,219 subjects to receive either the standard th ree-times-weekly (TIW) interferon alfa-2b dose (3 MIQ or the once-weekly (Q W) peginterferon alfa-2b (0.5, 1.0, or 1.5 mug/kg). Subjects were treated f or 48 weeks and then followed for an additional 24 weeks. All 3 peginterfer on alfa-2b doses significantly (P less than or equal to .042) improved viro logic response rates (loss of detectable serum HCV RNA) after treatment and after follow-up, as compared with interferon alfa-2b. Unlike the end-of-tr eatment virologic response, the sustained virologic response rate was not d ose-related above 1.0 mug/kg peginterferon alfa-2b because of a higher rela pse rate among patients treated with 1.5 mug/kg peginterferon alfa-2b, part icularly among patients infected with genotype 1. All 3 peginterferon alfa- 2b doses decreased liver inflammation to a greater extent than did interfer on alfa-2b, particularly in subjects with sustained responses. No new adver se events were reported, and the majority of adverse events and changes in laboratory values were mild or moderate. In conclusion, peginterferon alfa- 2b maintained (0.5 mug/kg) or surpassed (1.0, 1.5 mug/kg) the clinical effi cacy of interferon alfa-2b while preserving its safety profile. The higher rate of virologic response during treatment with 1.5 mug/kg peginterferon a lfa-2b in patients infected with genotype 1 and high viral levels warrants further evaluation.