title: Antiviral therapy and fibrosis progression in patients with mild-moderate hepatitis C recurrence after liver transplantation. A randomized controlled study.
abstract: OBJECTIVE
  We evaluated the effect of antiviral therapy on fibrosis progression in patients with histological features of mild/moderate HCV disease recurrence defined by a Grading score≥4 and Staging score up to 3 (Ishak) at 1 year after liver transplantation.
  
  
  METHODS
  Seventy-three consecutive patients with mild/moderate recurrence were randomized either to no treatment or to receive Pegilated-Interferon-alfa-2b and ribavirin for 52 weeks. Liver biopsies obtained at baseline (1 year after transplantation) and 2 years afterwards were evaluated for assessment of disease progression, defined as worsening of at least 2 staging points or progression to stage 4 or higher.
  
  
  RESULTS
  As for these two major histological end points there were no statistically significant differences between the 2 groups (36.1% vs. 50%, p=0.34 and 36.1% vs. 38.9%, p=1). Fifteen treated patients (41%) achieved a sustained virological response which was associated with a reduced risk of fibrosis worsening for both endpoints when compared to viremic patients (p=0.04).
  
  
  CONCLUSIONS
  Although antiviral-therapy was beneficial in preventing fibrosis progression in patients achieving a sustained virological response, the majority of the overall population of our patients with mild-moderate disease recurrence could not benefit from antiviral therapy either because they either could not be treated or did not respond to treatment (EudraCT number: 2005-005760).
authors.affiliation: Department of Hepatology and Liver Unit, Niguarda Hospital, Milan, Italy. luca.belli@ospedaleniguarda.it
authors.forename: Luca S
authors.initials: LS
authors.lastname: Belli
authors.forename: Riccardo
authors.initials: R
authors.lastname: Volpes
authors.forename: Ivo
authors.initials: I
authors.lastname: Graziadei
authors.forename: Stefano
authors.initials: S
authors.lastname: Fagiuoli
authors.forename: Peter
authors.initials: P
authors.lastname: Starkel
authors.forename: Patrizia
authors.initials: P
authors.lastname: Burra
authors.forename: Alberto B
authors.initials: AB
authors.lastname: Alberti
authors.forename: Bruno
authors.initials: B
authors.lastname: Gridelli
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Vogel
authors.forename: Luisa
authors.initials: L
authors.lastname: Pasulo
authors.forename: Eleonora
authors.initials: E
authors.lastname: De Martin
authors.forename: Maria
authors.initials: M
authors.lastname: Guido
authors.forename: Luciano
authors.initials: L
authors.lastname: De Carlis
authors.forename: Jan
authors.initials: J
authors.lastname: Lerut
authors.forename: Umberto
authors.initials: U
authors.lastname: Cillo
authors.forename: Andrew K
authors.initials: AK
authors.lastname: Burroughs
authors.forename: Giovambattista
authors.initials: G
authors.lastname: Pinzello
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D001706:Biopsy; D016009:Chi-Square Distribution; D018450:Disease Progression; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology*; D008103:Liver Cirrhosis / Q000473:pathology* / Q000821:virology; D016031:Liver Transplantation; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012254:Ribavirin / Q000627:therapeutic use*; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b