title: Unfavourable effects of colchicine in combination with interferon-alpha in the treatment of chronic hepatitis C.
abstract: BACKGROUND
  The prognosis of chronic hepatitis depends on the progression of hepatic fibrosis.
  
  
  OBJECTIVE
  To investigate whether the antifibrotic drug colchicine, in combination with interferon-alpha 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-alpha, 6 MU t.i.w. for 6 months followed by 3 MU 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-alpha and 31 received interferon-alpha 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-alpha (68% and 47%, respectively) than in the interferon-alpha 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-alpha 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-alpha and 6% of the interferon-alpha 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-alpha worsens the effectiveness of interferon-alpha alone in HCV chronic hepatitis. These alarming findings prompted us to interrupt the trial at this stage.
authors.affiliation: Chairs of Gastroenterology, Department of Public Health, University of Rome Tor Vergata, Italy. angelico@med.uniroma2.it
authors.forename: M
authors.initials: M
authors.lastname: Angelico
authors.forename: M
authors.initials: M
authors.lastname: Cepparulo
authors.forename: A
authors.initials: A
authors.lastname: Barlattani
authors.forename: A
authors.initials: A
authors.lastname: Liuti
authors.forename: S
authors.initials: S
authors.lastname: Gentile
authors.forename: M
authors.initials: M
authors.lastname: Hurtova
authors.forename: D
authors.initials: D
authors.lastname: Ombres
authors.forename: P
authors.initials: P
authors.lastname: Guarascio
authors.forename: G
authors.initials: G
authors.lastname: Rocchi
authors.forename: F
authors.initials: F
authors.lastname: Angelico
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003078:Colchicine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006074:Gout Suppressants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
chemical_list: D000998:Antiviral Agents; D006074:Gout Suppressants; D016898:Interferon-alpha; D000410:Alanine Transaminase; D003078:Colchicine