A multicenter, randomized, controlled trial of interferon alfacon-1 compared with alpha-2a-interferon in Chinese patients with chronic hepatitis C virus infection

Background: a-Interferons are the accepted therapy for patients infected wi th chronic hepatitis C virus (HCV) in China. However, consensus interferon (CIFN) for HCV treatment is effective in patients with chronic hepatitis C from Western countries. Methods: This randomized, controlled trial was conducted to determine the s afety and efficacy of CIFN at two doses, and to compare it with alpha -2a-i nterferon (IFN-alpha -2a) in Chinese patients with chronic HCV. Interferon- naive patients with chronic HCV infection (n = 187) were randomly chosen to receive 15 mug CIFN or 9 mug or 3 MU IFN-alpha -2a subcutaneously, three t imes a week for 24 weeks, followed by a 24 week observation period. Efficac y was evaluated by the normalization of serum alanine aminotransferase (ALT ) and the non-detectability disappearance of serum HCV-RNA by using reverse -transcription-polymerase chain reaction. The safety of CIFN was evaluated by recording the type and severity of adverse effects. Results: The combined ALT and HCV-RNA end-of-treatment and sustained respon ses were observed to be greater for treatment with 15 mug CIFN (59.0% and 5 5.7%, respectively) compared to IFN alpha -2a (36.1% and 39.3%, respectivel y; P = 0.01 for the end-of-treatment, P = 0.07 for the sustained response). The combined ALT and HCV-RNA end-of-treatment and sustained responses for treatment with 9 mug CIFN (both 49.2%) were higher than those for IFN-alpha -2a (not statistically significant). Data were analyzed by using a logisti c-multiple-variate regression model, which indicated that the higher IFN do se (15 mug or 9 mug CIFN vs 3 MU IFN-alpha -2a; P < 0.01) appeared to be as sociated with a better sustained response. The type, frequency and severity of adverse effects were comparable across treatment groups. Conclusions: Consensus interferon appears to be safe and effective at conce ntrations of 9 and 15 <mu>g, but 15 mug CIFN may be more effective than 3 M U IFN-alpha -2a, without increased toxicity. (C) 2000 Blackwell Science Asi a Pty Ltd.