title: Histological response to pegIFNalpha-2a (40KD) plus ribavirin in HIV-hepatitis C virus co-infection.
abstract: OBJECTIVE
  Paired liver biopsies from patients enrolled in the multinational AIDS PEGASYS Ribavirin International Co-infection Trial were analysed to investigate a possible correlation between virological and histological responses.
  
  
  METHODS
  A total of 860 HIV-hepatitis C virus (HCV)-co-infected patients were randomly assigned to receive pegIFNalpha-2a (40KD) 180 microg/week plus 800 mg daily ribavirin, pegIFNalpha-2a (40KD) plus placebo or conventional IFNalpha-2a 3 MIU three times a week plus ribavirin for 48 weeks. Paired biopsies were obtained from 401 patients and scored locally using the Ishak-modified histological activity index (HAI). The second biopsy was obtained, on average, 26 weeks or more after the end of treatment. Histological response was defined as a 2-point or greater reduction in the HAI score.
  
  
  RESULTS
  The histological response rate was significantly higher in patients receiving pegIFNalpha-2a (40KD) plus ribavirin (57%) than in patients receiving pegIFNalpha-2a (40KD) plus placebo (39%; P < 0.017) or IFNalpha-2a plus ribavirin (41%; P = 0.04). Histological response was correlated with virological response, with the histological response rate ranging from 62 to 74% in patients who achieved a sustained virological response (SVR). Histological response was also seen in 32-43% of patients not achieving an SVR. A higher total HAI score was the only prognostic factor for achieving histological response.
  
  
  CONCLUSIONS
  The histological response rate was significantly higher in HIV-HCV-co-infected patients who received pegIFNalpha-2a (40KD) plus ribavirin than in those receiving pegIFNalpha-2a (40KD) plus placebo or IFNalpha-2a plus ribavirin. Histological response was correlated with virological response, although a substantial proportion of patients who did not achieve an SVR experienced histological improvement.
authors.affiliation: Department of Internal Medicine, Virgen del Rocio University Hospital, Avenida Manuel Siurot s/n, 41013 Seville, Spain. lissen@cica.es
authors.forename: Eduardo
authors.initials: E
authors.lastname: Lissen
authors.forename: Nathan
authors.initials: N
authors.lastname: Clumeck
authors.forename: Ricardo
authors.initials: R
authors.lastname: Sola
authors.forename: Maria
authors.initials: M
authors.lastname: Mendes-Correa
authors.forename: Julio
authors.initials: J
authors.lastname: Montaner
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
authors.forename: Jean
authors.initials: J
authors.lastname: DePamphilis
authors.forename: Mário
authors.initials: M
authors.lastname: Pessôa
authors.forename: Peter
authors.initials: P
authors.lastname: Buggisch
authors.forename: Janice
authors.initials: J
authors.lastname: Main
authors.forename: Douglas
authors.initials: D
authors.lastname: Dieterich
mesh_terms: D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D001706:Biopsy; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000150:complications* / Q000473:pathology; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008099:Liver / Q000473:pathology*; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a