title: Randomized comparison of 12 or 24 weeks of peginterferon alpha-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection.
abstract: Previous trials investigating the efficacy of treatment durations shorter than the standard of 24 weeks for chronic hepatitis C virus (HCV) genotype 2/3 infections have yielded discordant results. The aims of this investigator-initiated phase III study were to compare the efficacy of 12 or 24 weeks of treatment and to identify patients suitable for short-term therapy. Three hundred eighty-two genotype 2/3-infected patients [intention-to-treat (ITT) population] at 31 centers in Denmark, Finland, Norway, and Sweden were randomized to 12 or 24 weeks of peginterferon alpha-2a (180 microg/week) plus ribavirin (800 mg/day). Twelve weeks of therapy was inferior to 24 weeks in the ITT population (sustained viral response [SVR] rates: 59% versus 78%, P < 0.0001) and in the subgroups of patients infected with genotype 2 (56% versus 82%, P = 0.006) or 3 (58% versus 78%, P = 0.0015). These differences were observed regardless of the fibrosis stage. Age and HCV-RNA levels on days 7 and 29 were independent predictors of SVR. Short-term treatment was useful in patients < 40 years old, especially if HCV-RNA was undetectable on day 29, and also in patients > or = 40 years old, provided that HCV-RNA was below 1000 IU/mL on day 7 in addition to being undetectable on day 29. If neither of these two criteria were met for patients > or = 40 years old, 24 weeks of therapy was superior (P < 0.0001).
  
  
  CONCLUSIONS
  Peginterferon/ribavirin treatment for 12 weeks in HCV genotype 2/3 infection is overall inferior to 24 weeks of treatment but may be useful in some patients with a rapid initial clearance of virus.
authors.affiliation: Department of Infectious Diseases, Göteborg University, Göteborg, Sweden. martin.lagging@medfak.gu.se
authors.forename: Martin
authors.initials: M
authors.lastname: Lagging
authors.forename: Nina
authors.initials: N
authors.lastname: Langeland
authors.forename: Court
authors.initials: C
authors.lastname: Pedersen
authors.forename: Martti
authors.initials: M
authors.lastname: Färkkilä
authors.forename: Mads Rauning
authors.initials: MR
authors.lastname: Buhl
authors.forename: Kristine
authors.initials: K
authors.lastname: Mørch
authors.forename: Amar P
authors.initials: AP
authors.lastname: Dhillon
authors.forename: Asa
authors.initials: A
authors.lastname: Alsiö
authors.forename: Kristoffer
authors.initials: K
authors.lastname: Hellstrand
authors.forename: Johan
authors.initials: J
authors.lastname: Westin
authors.forename: Gunnar
authors.initials: G
authors.lastname: Norkrans
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a