title: Maintenance therapy with gradual reduction of the interferon dose over one year improves histological response in patients with chronic hepatitis C with biochemical response: results of a randomized trial.
abstract: OBJECTIVE
  Our aim was to assess whether histological response was improved by continuing interferon-alpha (IFN) treatment in patients with chronic hepatitis C (HCV) with a biochemical response and no viral clearance after a usual IFN treatment.
  
  
  METHODS
  Fifty-seven patients with normal alanine aminotransferase (ALAT) levels and positive HCV RNA at the end of a 1 year IFN treatment were randomly assigned to either group 1 (n = 28) where IFN was stopped, or group 2 (n = 29) where IFN was continued for 1 more year with gradual reduction of the dose to keep serum ALAT activity below the upper limit of normal. Liver biopsies were obtained before, and then 6 months after the end of treatment.
  
  
  RESULTS
  Knodell's index improved between paired biopsies in group 2 (8.2+/-2.4 vs. 5.5+/-2.1), but not in group 1 (8+/-2.3 vs. 6.5+/-2). In post-treatment biopsies, the METAVIR activity score was significantly lower in group 2 than in group 1 (0.7+/-0.2 vs. 1.1+/-0.3, P < 0.05). In group 2, an improvement of the METAVIR fibrosis score was observed (1.3+/-0.4 vs. 1.1+/-0.2), whereas fibrosis progressed in group 1 (1.3+/-0.4 vs. 1.6+/-0.4).
  
  
  CONCLUSIONS
  Maintenance therapy by the minimal dose of IFN able to maintain biochemical response prevents histological progression in the sub-group of patients without virological response.
authors.affiliation: Service de Médecine Interne-Fédération Digestive, Hĵpital Purpan, Toulouse, France. alric.l@chu-toulouse.fr
authors.forename: L
authors.initials: L
authors.lastname: Alric
authors.forename: M
authors.initials: M
authors.lastname: Duffaut
authors.forename: J
authors.initials: J
authors.lastname: Selves
authors.forename: K
authors.initials: K
authors.lastname: Sandre
authors.forename: M
authors.initials: M
authors.lastname: Mularczyck
authors.forename: J
authors.initials: J
authors.lastname: Izopet
authors.forename: H
authors.initials: H
authors.lastname: Desmorat
authors.forename: C
authors.initials: C
authors.lastname: Bureau
authors.forename: N
authors.initials: N
authors.lastname: Chaouche
authors.forename: B
authors.initials: B
authors.lastname: Dalbergue
authors.forename: J P
authors.initials: JP
authors.lastname: Vinel
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001706:Biopsy; D005260:Female; D005355:Fibrosis; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins; D013997:Time Factors
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000410:Alanine Transaminase