title: Induction interferon and ribavirin for re-treatment of chronic hepatitis C patients unresponsive to interferon alone.
abstract: BACKGROUND
  The optimal treatment for hepatitis C patients unresponsive to interferon is unclear. High-dose induction interferon may enhance early viral clearance, whilst ribavirin reduces relapse; in combination, they may improve sustained virological response rates.
  
  
  OBJECTIVE
  To compare the efficacy and safety of re-treatment with interferon induction, with or without ribavirin, in interferon non-responders.
  
  
  METHODS
  We randomized 218 biochemical interferon non-responders to 10 MU interferon alpha 2b daily for 4 weeks, followed by 5 MU thrice weekly for 48 weeks plus ribavirin (II + R), or to the same interferon regimen plus placebo (II + P). All patients were viraemic at entry.
  
  
  RESULTS
  The sustained virological response in the II + R group was 39%[95% confidence interval (CI), 30-48%], compared with 16% (95% CI, 9-23%) in the II + P group (P < 0.002). The study drug was discontinued for intolerable symptoms during induction in 9% of the II + R group and in 5% of the II + P group. By logistic regression, a sustained virological response was more likely following II + R treatment (odds ratio, 4.4; 95% CI, 2.1-9.7) and less likely in patients with genotype 1 or 4 (odds ratio, 0.16; 95% CI, 0.07-0.36).
  
  
  CONCLUSIONS
  High-dose induction interferon plus ribavirin is well tolerated and effective for patients unresponsive to interferon alone.
authors.affiliation: Department of Medicine, Monash Medical Centre, Monash University, Melbourne, Clayton, VIC, Australia. William.Sievert@med.monash.edu.au
authors.forename: W
authors.initials: W
authors.lastname: Sievert
authors.forename: R
authors.initials: R
authors.lastname: Batey
authors.forename: L
authors.initials: L
authors.lastname: Mollison
authors.forename: S
authors.initials: S
authors.lastname: Pianko
authors.forename: J
authors.initials: J
authors.lastname: McDonald
authors.forename: G
authors.initials: G
authors.lastname: Marinos
authors.forename: W
authors.initials: W
authors.lastname: Reed
authors.forename: S
authors.initials: S
authors.lastname: Warner
authors.forename: S
authors.initials: S
authors.lastname: Bowden
authors.forename: R
authors.initials: R
authors.lastname: De Solom
authors.forename: P
authors.initials: P
authors.lastname: Bhathal
mesh_terms: D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin