title: High rate of long-term virological response after a 1-year course of interferon +/- ribavirin in chronic hepatitis C relapsers. Results of a 191 patients randomized trial.
abstract: We investigated the long-term efficacy of a 12-month course of interferon (IFN)+ribavirin in chronic hepatitis C relapsers. We randomized 191 relapsers with a 2:1 ratio to receive 3 million units three times a week of interferon alpha (IFN alpha)-2b+ribavirin (1-1.2 g/day) (group A=127 patients) or IFN alpha-2b (group B=60 patients) of same dosage and duration for 1 year. General and hepatitis C data of group A and B patients were similar. The main goal of the study was to determine the rate of sustained virological response evaluated 1 year after treatment.
  
  
  RESULTS
  Virological sustained response (SR) was 61% and 12% for groups A and B, respectively (P<0.001). A significant histological improvement was observed in both treatment groups. The Metavir activity score became significantly lower in the IFN+ribavirin group than in the IFN group (P<0/0001). The Metavir fibrosis scores remained unchanged. Also, at the end of the treatment, the virological response was 69% (88/127) for group A and 33% (20/60) for group B (P<0.001).
  
  
  CONCLUSIONS
  One-year retreatment of relapsers with the combination of IFN+ribavirin led to 61% of virological SR and to a significant improvement of histological activity. Therefore, the therapeutic schedule presented here can be considered of particular interest for the retreatment of relapsers.
authors.affiliation: Service des Maladies du Foie and INSERM U-522, Hôpital Pontchaillou, 35033 Rennes, France. boucher@rennes.fnclcc.fr
authors.forename: Eveline J
authors.initials: EJ
authors.lastname: Boucher
authors.forename: Sylvie
authors.initials: S
authors.lastname: Jacquelinet
authors.forename: Valérie
authors.initials: V
authors.lastname: Canva
authors.forename: Bruno
authors.initials: B
authors.lastname: Turlin
authors.forename: Christian
authors.initials: C
authors.lastname: Jacquelinet
authors.forename: Ronald
authors.initials: R
authors.lastname: Colimon
authors.forename: Yves
authors.initials: Y
authors.lastname: Deugnier
authors.forename: Dominique
authors.initials: D
authors.lastname: Guyader
authors.forename: Pierre
authors.initials: P
authors.lastname: Brissot
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012008:Recurrence; D019233:Retreatment; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin