title: Ribavirin treatment for patients with chronic hepatitis C: results of a placebo-controlled study.
abstract: OBJECTIVE
  Small, uncontrolled studies of ribavirin for patients with chronic hepatitis C have reported efficacy in chronic hepatitis C. We have evaluated the efficacy and safety of a 24-week course of oral ribavirin in patients with chronic hepatitis C, compared to placebo.
  
  
  METHODS
  A total of 114 patients were randomised to ribavirin or placebo. Ribavirin was administered in doses of 1000 or 1200 mg/day for 24 weeks. Efficacy was determined in the intention-to-treat population: 76 received ribavirin and 38 placebo.
  
  
  RESULTS
  Ribavirin was significantly more effective than placebo in reducing and normalising serum ALT levels: 42/76 (55%) of ribavirin-treated patients vs 2/38 (5%) placebo recipients had either normalisation of the ALT levels or a reduction from baseline of at least 50% (p < 0.001). ALT levels were normal in 22/76 (29%) of ribavirin-treated patients vs 0/38 placebo recipients (p < 0.001). Twenty-four weeks after stopping ribavirin, the majority of patients had abnormal ALT levels. There was no difference between the treatment groups in reduction or disappearance of HCV-RNA levels. HCV RNA disappeared during treatment in 3% of ribavirin-treated patients and 3% of placebo recipients. More ribavirin than placebo patients showed improvement in total Knodell score (45% vs 31%), but these differences were not statistically significant. Analysis of each component of a histology activity index revealed no statistically significant differences between treatment groups. Ribavirin patients had fewer lymphoid aggregates than did placebo recipients at the post-treatment assessment (p = 0.05). Ribavirin was associated with reversible haemolytic anaemia: a fall in haemoglobin occurred in 3% of placebo- and 32% (25/78) of ribavirin-treated patients, respectively (p < 0.001).
  
  
  CONCLUSIONS
  These data indicate that ribavirin was no more effective than placebo in reducing or eliminating HCV-RNA levels, and was not significantly more effective than placebo in improving hepatic histology after 6 months of treatment. The role of a 6-month treatment of chronic hepatitis C with ribavirin alone, without a significant effect on HCV RNA, is therefore limited.
authors.affiliation: Department of Medicine, Royal Free Hospital, London, United Kingdom.
authors.forename: G
authors.initials: G
authors.lastname: Dusheiko
authors.forename: J
authors.initials: J
authors.lastname: Main
authors.forename: H
authors.initials: H
authors.lastname: Thomas
authors.forename: O
authors.initials: O
authors.lastname: Reichard
authors.forename: C
authors.initials: C
authors.lastname: Lee
authors.forename: A
authors.initials: A
authors.lastname: Dhillon
authors.forename: S
authors.initials: S
authors.lastname: Rassam
authors.forename: A
authors.initials: A
authors.lastname: Fryden
authors.forename: H
authors.initials: H
authors.lastname: Reesink
authors.forename: M
authors.initials: M
authors.lastname: Bassendine
authors.forename: G
authors.initials: G
authors.lastname: Norkrans
authors.forename: T
authors.initials: T
authors.lastname: Cuypers
authors.forename: N
authors.initials: N
authors.lastname: Lelie
authors.forename: P
authors.initials: P
authors.lastname: Telfer
authors.forename: J
authors.initials: J
authors.lastname: Watson
authors.forename: C
authors.initials: C
authors.lastname: Weegink
authors.forename: P
authors.initials: P
authors.lastname: Sillikens
authors.forename: O
authors.initials: O
authors.lastname: Weiland
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D000410:Alanine Transaminase