title: Treatment of recurrent HCV infection following liver transplantation: results of a multicenter, randomized, versus placebo, trial of ribavirin alone as maintenance therapy after one year of PegIFNα-2a plus ribavirin.
abstract: OBJECTIVE
  We aimed at determining the effect of maintenance therapy with ribavirin alone, after a year of combined peginterferon-alfa 2a (PegIFNα-2a) and ribavirin therapy, on viral response and liver histology after liver transplantation (LT).
  
  
  METHODS
  Hundred and one patients with recurrent HCV and a minimum of stage 1 fibrosis (METAVIR scoring), 1-5years after LT, were enrolled. PegIFNα-2a and ribavirin were initiated at 90 μg/wk and 600 mg/d, respectively, then increased or adjusted as a function of tolerance. At 12 months, combination therapy was discontinued and patients were randomized to ribavirin or placebo for a further 12 months. Growth factor use was permitted.
  
  
  RESULTS
  At 18 months, a sustained virological response (SVR) was obtained in 47.9% of patients in Per Protocol (PP) analysis, and was higher in patients with genotype 2 or 3 than in patients with genotype 1 or 4, in patients with genotypes 1+4 receiving ciclosporine than in those receiving tacrolimus, in patients with worse renal function, in those having received EPO, in patients with lower weight, and in those with lower viral load at 3 months. Using logistic regression, only the early viral response, recipient weight and renal function were independently associated with better SVR. SVR, viral load, activity, and fibrosis scores were similar, at M18 and M30, in patients randomized to ribavirin, or to placebo.
  
  
  CONCLUSIONS
  A PP SVR was achieved in 47.9% of patients with established recurrent hepatitis C after LT. Maintenance therapy with ribavirin alone does not improve the virological response or the histological parameters.
authors.affiliation: Hôpital Cochin, Paris, France; Hôpital Saint-Antoine, Paris, France. yvon.calmus@sat.aphp.fr
authors.forename: Yvon
authors.initials: Y
authors.lastname: Calmus
authors.forename: Christophe
authors.initials: C
authors.lastname: Duvoux
authors.forename: Georges
authors.initials: G
authors.lastname: Pageaux
authors.forename: Philippe
authors.initials: P
authors.lastname: Wolf
authors.forename: Lionel
authors.initials: L
authors.lastname: Rostaing
authors.forename: Claire
authors.initials: C
authors.lastname: Vanlemmens
authors.forename: Danielle
authors.initials: D
authors.lastname: Botta-Fridlund
authors.forename: Sébastien
authors.initials: S
authors.lastname: Dharancy
authors.forename: Jean
authors.initials: J
authors.lastname: Gugenheim
authors.forename: François
authors.initials: F
authors.lastname: Durand
authors.forename: Martine
authors.initials: M
authors.lastname: Néau-Cransac
authors.forename: Olivier
authors.initials: O
authors.lastname: Boillot
authors.forename: Olivier
authors.initials: O
authors.lastname: Chazouillères
authors.forename: Laurence
authors.initials: L
authors.lastname: Samelson
authors.forename: Karim
authors.initials: K
authors.lastname: Boudjema
authors.forename: Didier
authors.initials: D
authors.lastname: Samuel
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016572:Cyclosporine / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000502:physiology; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D060828:Induction Chemotherapy; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007668:Kidney / Q000502:physiology; D008103:Liver Cirrhosis / Q000150:complications / Q000473:pathology; D016031:Liver Transplantation; D016015:Logistic Models; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016559:Tacrolimus / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D016898:Interferon-alpha; D010919:Placebos; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D016572:Cyclosporine; C100416:peginterferon alfa-2a; D016559:Tacrolimus