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Unfavourable effects of colchicine in combination with interferon‐α in the treatment of chronic hepatitis C
Author(s) -
Angelico M.,
Cepparulo M.,
Barlattani A.,
Liuti A.,
Gentile S.,
Hurtova M.,
Ombres D.,
Guarascio P.,
Rocchi G.,
Angelico F.
Publication year - 2000
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2000.00857.x
Subject(s) - medicine , interferon , colchicine , gastroenterology , alpha interferon , interferon alfa , alanine transaminase , ribavirin , hepatitis c virus , chronic hepatitis , hepatitis c , immunology , virus
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 interferon‐α, 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.