title: High predictive value of early viral kinetics in retreatment with peginterferon and ribavirin of chronic hepatitis C patients non-responders to standard combination therapy.
abstract: OBJECTIVE
  To evaluate the efficacy of peginterferon alfa-2b and ribavirin in unselected consecutive patients with chronic hepatitis C, treated outside of trials, who were relapsers or non-responders to interferon and ribavirin combination.
  
  
  METHODS
  One hundred and fifty-four patients were evaluated. There were 101 non-responders and 53 relapsers to standard combination therapy. Patients were retreated with peginterferon alfa-2b 1.5 microg/kg/wk plus ribavirin 1000-1200 mg/day during 48 weeks.
  
  
  RESULTS
  Forty-four patients (28.6%) achieved sustained virological response (SVR). Rapid (week 4) and early (week 12) virological response had high negative predictive values of SVR (94% and 97%, respectively); however positive predictive values were relatively low (52% and 49%, respectively). Relapsers had higher SVR rates (58.5%) than non-responders (13%) p<0.0001. In non-responders, SVR raised to 50% in patients with genotype non-1 and mild or moderate fibrosis. In multivariate analysis, predictors of SVR were: relapse after interferon plus ribavirin combination, mild or moderate fibrosis, genotype non-1 and baseline viral load <2 million copies/ml.
  
  
  CONCLUSIONS
  Relapsers to interferon plus ribavirin therapy, and non-responders with genotype non-1 and mild or moderate fibrosis, achieved a relatively high SVR rate following retreatment with peginterferon plus ribavirin. Early viral kinetics had a high negative predictive value of SVR.
authors.affiliation: Service d'Hépatologie and INSERM CRB3, Hôpital Beaujon, AP-HP, Université Paris VII, Clichy, France.
authors.forename: Rami
authors.initials: R
authors.lastname: Moucari
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Ripault
authors.forename: Valérie
authors.initials: V
authors.lastname: Oulès
authors.forename: Michèle
authors.initials: M
authors.lastname: Martinot-Peignoux
authors.forename: Tarik
authors.initials: T
authors.lastname: Asselah
authors.forename: Nathalie
authors.initials: N
authors.lastname: Boyer
authors.forename: Ahmed
authors.initials: A
authors.lastname: El Ray
authors.forename: Dominique
authors.initials: D
authors.lastname: Cazals-Hatem
authors.forename: Dominique
authors.initials: D
authors.lastname: Vidaud
authors.forename: Dominique
authors.initials: D
authors.lastname: Valla
authors.forename: Marc
authors.initials: M
authors.lastname: Bourlière
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011237:Predictive Value of Tests; D011994:Recombinant Proteins; D012008:Recurrence; D019233:Retreatment; D012254:Ribavirin / Q000627:therapeutic use*; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b