Unfavourable effects of colchicine in combination with interferon-α in the treatment of chronic hepatitis C

Abstract

Background: The prognosis of chronic hepatitis depends on the progression of hepatic fibrosis. Aim: To investigate whether the antifibrotic drug colchicine, in combination with interferon-α has a role in the treatment of chronic hepatitis C. Methods: Sixty-five HCV-RNA positive patients with chronic hepatitis were randomized to receive interferonα, 6 (M)U t.i.w. for 6 months followed by 3 (M)U t.i.w. for further 6 months, with or without the adjunct of colchicine, 1 mg o.d., 6 days a week, for 3 years. We report an interim analysis after the first 18 months. Results: Thirty-four patients received interferon-α and 31 received interferon-α and colchicine. The two groups were comparable for baseline data, including HCV-RNA levels. genotypes and histological grading/staging. Drop-outs and side-effects were similar. The proportion of patients who achieved alanine transaminase normalization or undetectable HCV-RNA at month 6 was higher in the interferon-α (68% and 47%, respectively) than in the interferon-α plus colchicine group (32% and 23%. P = 0.004 and P = 0.04, respectively). End-of-treatment biochemical and virological response occurred in 41% and 29% of the interferon-α and 19% and 10% of the combination group, respectively (P = 0.05 and P = 0.05). Sustained biochemical response occurred in 26% of the interferon-α and 6% of the interferon-α plus colchicine group (P = 0.03), corresponding percentages of sustained HCV-RNA loss being 21% and 3% (P = 0.04). Conclusions: The combination of colchicine and interferon-α worsens the effectiveness of interferon-α alone in HCV chronic hepatitis. These alarming findings prompted us to interrupt the trial at this stage.