title: Pegylated interferon-α2a plus ribavirin for chronic hepatitis C in a real-life setting: the Hepatys French cohort (2003-2007).
abstract: BACKGROUND
  The aim of this study was to document in real life the characteristics and management of hepatitis C patients treated with pegylated interferon-α2a and ribavirin, and the efficacy of treatment (sustained virological response [SVR]).
  
  
  METHODS
  This observational study enrolled hepatitis C patients initiating pegylated interferon-α2a and ribavirin treatment.
  
  
  RESULTS
  A total of 2,066 patients were included, of which 70% were treatment-naive, 53% had genotype (G) 1 and 38% G2 or G3 infection, and 35% had an F3-F4 Metavir score. In total, 18% of patients treated for 24 weeks and 39% of patients treated for 48 weeks prematurely stopped treatment, mainly because of side effects. The SVR rate (intent-to-treat population) was 39%: 43% in naive patients and 31% in treatment-failure patients. In the complete case analysis population, this was 49%: 54% in naive patients and 37% in treatment-failure patients. Among naive patients, the SVR rate was 42% in G1 carriers and 69% in G2 or G3 carriers. The SVR rate was 69% in naive G1 patients without fibrosis (F0; versus 44% in F1-F2 versus 31% in F3-F4; P<0.001). In naive patients, G2 or G3, low viral load (<800,000 IU/ml) and age ≤40 years were predictive factors for SVR. In treatment-failure patients, low viral load, no or low fibrosis stage (F0-F1) and no treatment modification were predictive factors of SVR.
  
  
  CONCLUSIONS
  In patients treated in a real-life setting, adherence to therapy, SVR rates, predictive factors of SVR and safety results were close to those observed in randomized trials. A high SVR in G1 naive patients with no fibrosis warrants further study and might suggest earlier treatment.
authors.affiliation: Service d'Hépato-Gastroentérologie, Hôpital Saint-Joseph, Marseille, France. mbourliere@hopital-saint-joseph.fr
authors.forename: Marc
authors.initials: M
authors.lastname: Bourlière
authors.forename: Denis
authors.initials: D
authors.lastname: Ouzan
authors.forename: Michel
authors.initials: M
authors.lastname: Rosenheim
authors.forename: Michel
authors.initials: M
authors.lastname: Doffoël
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Pawlotsky
authors.forename: Laurence
authors.initials: L
authors.lastname: Salomon
authors.forename: Francis
authors.initials: F
authors.lastname: Fagnani
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Rouanet
authors.forename: Alexandrina
authors.initials: A
authors.lastname: Pinta
authors.forename: Muriel
authors.initials: M
authors.lastname: Vray
mesh_terms: D000328:Adult; D000367:Age Factors; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D054316:Biomarkers, Pharmacological / Q000032:analysis; D015331:Cohort Studies; D005260:Female; D005602:France; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D019370:Observation; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D012367:RNA, Viral / Q000096:biosynthesis; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D054316:Biomarkers, Pharmacological; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a