title: Interferon-alpha plus ribavirin in chronic hepatitis C resistant to previous interferon-alpha course: results of a randomized multicenter trial.
abstract: OBJECTIVE
  Interferon-alpha plus ribavirin seem to be more efficacious than interferon monotherapy in chronic hepatitis C. In a multicenter randomized trial, we evaluated the efficacy of this association for interferon-alpha resistant chronic hepatitis C.
  
  
  METHODS
  Fifty patients who were non-responders to recombinant or lymphoblastoid interferon-alpha were randomized to receive either ribavirin (800 mg/day) plus leucocytic interferon-alpha (3 mega units thrice weekly) or the same dose of interferon-alpha alone, for 6 months. Effects of therapy were evaluated by serum aminotransferase and hepatitis C virus RNA levels and control liver biopsies.
  
  
  RESULTS
  At the end of treatment, aminotransferase levels become normal in 9/26 patients receiving combination therapy (35% [confidence interval, 16% to 53%]) and in 2/24 receiving interferon-alpha alone (8% [confidence interval, -3% to 19%]) (p = 0.03). Aminotransferase normalization was never associated with hepatitis C virus RNA clearance. All patients with normal aminotransferase relapsed after discontinuation of therapy. At the end of treatment, mean hepatitis C virus RNA levels significantly decreased only in the group receiving combination therapy, but returned to pretreatment values 6 months thereafter. No histological improvement was observed in either group.
  
  
  CONCLUSIONS
  There is no indication for treatment with interferon-alpha at the dose of 3 mega units thrice weekly plus 800 mg/day of ribavirin for 6 months in chronic hepatitis C resistant to interferon-alpha.
authors.affiliation: Dipartimento di Medicina Interna, Cardioangiologia ed Epatologia, Università di Bologna, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Andreone
authors.forename: A
authors.initials: A
authors.lastname: Gramenzi
authors.forename: C
authors.initials: C
authors.lastname: Cursaro
authors.forename: G
authors.initials: G
authors.lastname: Sbolli
authors.forename: S
authors.initials: S
authors.lastname: Fiorino
authors.forename: L
authors.initials: L
authors.lastname: Di Giammarino
authors.forename: R
authors.initials: R
authors.lastname: Miniero
authors.forename: A
authors.initials: A
authors.lastname: D'Errico
authors.forename: G
authors.initials: G
authors.lastname: Gasbarrini
authors.forename: M
authors.initials: M
authors.lastname: Bernardi
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007249:Inflammation; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin