Abstract: Objective To investigate the efficacy and safety of type Y pegylated interferon α-2b （YPegIFNα-2b,40kD） in the treatment of patients with chronic hepatitis C virus genotypes 2/3 infection in a randomized,PegIFNα-2a-controlled phase III clinical trial. Methods A multi-center,randomized,open-label and positive controlled phase III clinical trial was conducted in this study. Chronic hepatitis C （CHC） patients who met inclusion criteria were randomly allocated in a ratio of 2:1 to 2 cohorts and treated with YPegIFNα-2b or PegIFNα-2a（180 μg）,respectively,and ribavirin for 24 weeks,and they were all followed-up for 24 weeks after discontinuation of the regimen. The primary efficacy was assessed by sustained virological response （SVR）. Results Two hundred fifty-five participants with genotypes 2 or 3 HCV infection were enrolled. Intention-to-treat analysis showed that SVR were 85.4%（95% CI 79.94%-90.94%） and 79.5% （95% CI 70.84%-88.20%） in patients treated with YPegIFNα-2b and PegIFNα-2a,respectively（P=0.2402）;95% confidence intervals of rate difference conformed to standard of non-inferiority. Positive predictive value of rapid virological response for SVR was 90.1%;Additionally,there were no significant differences in adverse effects（95.6% vs. 95.2%） and severe adverse effects（3.8% vs. 3.6%） between the YPegIFNα-2b- and control agent-treated patients with CHC. Conclusions YPegIFNα-2b provides an alternative efficacious treatment option in patients with chronic HCV genotypes 2/3 infection as its similar efficacy and safety to PegIFNα-2a in this pilot clinical trial.

Key words: Hepatitis C, Pegylated interferon α-2b;, Clinical trial