title: Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy.
abstract: OBJECTIVE
  Treatment with peginterferon alfa and ribavirin produces a sustained virologic response (SVR) in approximately 60% of hepatitis C virus (HCV)-infected patients. Alternate options are needed for patients who relapse or do not respond to therapy.
  
  
  METHODS
  This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 microg/kg/wk) plus weight-based ribavirin (800-1400 mg/day) in 2333 chronic HCV-infected patients with significant fibrosis/cirrhosis whose previous interferon alfa/ribavirin therapy failed. Patients with undetectable HCV-RNA at treatment week (TW) 12 received 48 weeks of therapy; patients with detectable HCV-RNA at TW12 could enter maintenance studies at TW18; 188 patients with low/detectable HCV-RNA at TW12 continued therapy at the investigator's request.
  
  
  RESULTS
  Overall, 22% of the patients attained SVR (56% with undetectable HCV-RNA and 12% with low/detectable HCV-RNA at TW12). SVR was better in relapsers (38%) than nonresponders (14%), regardless of previous treatment, and in patients previously treated with interferon-alfa/ribavirin (25%) than peginterferon alfa-ribavirin (17%). Predictors of response in patients with undetectable HCV-RNA at TW12 were genotype (2/3 vs 1, respectively; odds ratio [OR] 2.4; P < .0001), fibrosis score (F2 vs F4; OR, 2.2; F3 vs F4; OR, 1.7; P < .0001), and baseline viral load (< or =600,000 vs >600,000 IU/mL; OR, 1.4; P = .0223). These factors plus previous treatment and response were overall predictors of SVR. Safety was similar among fibrosis groups.
  
  
  CONCLUSIONS
  Peginterferon alfa-2b plus weight-based ribavirin is effective and safe in patients who failed interferon alfa/ribavirin therapy. Genotype, baseline viral load, and fibrosis stage were predictors of response.
authors.affiliation: Service d'hepatologie, Université Pierre et Marie Curie Liver Center, Hôpital La Pitié Salpêtrière, Paris, France. tpoynard@teaser.fr
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
authors.forename: Massimo
authors.initials: M
authors.lastname: Colombo
authors.forename: Jordi
authors.initials: J
authors.lastname: Bruix
authors.forename: Eugene
authors.initials: E
authors.lastname: Schiff
authors.forename: Ruben
authors.initials: R
authors.lastname: Terg
authors.forename: Steven
authors.initials: S
authors.lastname: Flamm
authors.forename: Ricardo
authors.initials: R
authors.lastname: Moreno-Otero
authors.forename: Flair
authors.initials: F
authors.lastname: Carrilho
authors.forename: Warren
authors.initials: W
authors.lastname: Schmidt
authors.forename: Thomas
authors.initials: T
authors.lastname: Berg
authors.forename: Thomas
authors.initials: T
authors.lastname: McGarrity
authors.forename: E Jenny
authors.initials: EJ
authors.lastname: Heathcote
authors.forename: Fernando
authors.initials: F
authors.lastname: Gonçales
authors.forename: Moises
authors.initials: M
authors.lastname: Diago
authors.forename: Antonio
authors.initials: A
authors.lastname: Craxi
authors.forename: Marcelo
authors.initials: M
authors.lastname: Silva
authors.forename: Pierre
authors.initials: P
authors.lastname: Bedossa
authors.forename: Pabak
authors.initials: P
authors.lastname: Mukhopadhyay
authors.forename: Louis
authors.initials: L
authors.lastname: Griffel
authors.forename: Margaret
authors.initials: M
authors.lastname: Burroughs
authors.forename: Clifford
authors.initials: C
authors.lastname: Brass
authors.forename: Janice
authors.initials: J
authors.lastname: Albrecht
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D017211:Treatment Failure
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