A randomized, double-blind, controlled trial of consensus interferon in the treatment of chinese patients with chronic hepatitis C

Abstract

OBJECTIVE: Patients with chronic hepatitis C virus (HCV) infection have an increased risk of developing cirrhosis or hepatocellular carcinoma. Consensus interferon (CIFN) offers sustained clinical efficacy to patients studied in the Western countries. This randomized, double-blind, controlled trial in 75 Chinese patients with chronic hepatitis C compared treatment with CIFN or placebo to determine whether CIFN had efficacy and safety in Chinese patients similar to that in Western patients. METHODS: Patients were randomized to receive CIFN (3 μg or 9 μg ) or placebo given subcutaneously 3 times/wk for 24 wk, followed by 24 wk of observation. Efficacy was assessed by normalization of serum alanine transaminase (ALT) and clearance of serum HCV RNA concentrations to undetectable levels by reverse-transcription polymerase chain reaction. RESULTS: There was a greater benefit with CIFN 9 μg than with CIFN 3 μg or placebo. At the end of 24 wk of treatment, the ALT response was 64%, 38.5%, and 8.4% for the 9-μg, 3-μg, and placebo-treated groups, respectively. After an additional 24 wk of observation, sustained ALT responses were 44%, 23.1%, and 12.5% for the 9-μg, 3-μg, and placebo-treated groups, respectively. HCV RNA clearance at the end of treatment was 56%, 42.3%, and 4.2%; and after 24 wk of additional observation, 40%, 11.5%, and 0% for the 9-μg, 3-μg, and placebo-treated groups, respectively. There were no unexpected adverse reactions to CIFN. CONCLUSIONS: The results show that administration of CIFN subcutaneously at 9 μg 3 times a week is safe and can effectively reduce serum ALT and HCV RNA concentrations in Chinese patients with chronic hepatitis C.