RESUMO
BACKGROUND: Alpha-interferons are the accepted therapy for patients infected with 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 safety and efficacy of CIFN at two doses, and to compare it with alpha-2a-interferon (IFN-alpha-2a) in Chinese patients with chronic HCV. Interferon-naive patients with chronic HCV infection (n = 187) were randomly chosen to receive 15 microg CIFN or 9 microg or 3 MU IFN-alpha-2a subcutaneously, three times a week for 24 weeks, followed by a 24 week observation period. Efficacy 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 responses were observed to be greater for treatment with 15 microg CIFN (59.0% and 55.7%, respectively) compared to IFN alpha-2a (36.1% and 39.3%, respectively; 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 microg CIFN (both 49.2%) were higher than those for IFN-alpha-2a (not statistically significant). Data were analyzed by using a logistic-multiple-variate regression model, which indicated that the higher IFN dose (15 microg or 9 microg CIFN vs 3 MU IFN-alpha-2a; P < 0.01) appeared to be associated 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 concentrations of 9 and 15 microg, but 15 microg CIFN may be more effective than 3 MU IFN-alpha-2a, without increased toxicity.
