title: A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients.
abstract: OBJECTIVE
  A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combination with ribavirin, in chronic hepatitis C patients. Efficacy data for prior relapsers are reported because treatment recommendations for this patient population are not well defined.
  
  
  METHODS
  This study was a multicenter, prospective, randomized clinical trial. The primary efficacy endpoint was sustained virologic response in naive patients (n = 348) and relapsers (n = 95).
  
  
  RESULTS
  Sustained virologic response rates were similar in naïve patients and relapsers, both for non-pegylated and pegylated interferon (respectively 27 and 26% and 54 and 43%). Pegylated interferon given for 48 weeks did not improved the relapse rate: 15.9 and 27.3% for non-pegylated and 16.7 and 30.4% for pegylated interferon, naïve vs relapsers respectively. Stepwise logistic regression analysis revealed a significant association between slow response (detectable HCV RNA at week 12 and undetectable at week 24) and relapse in patients with an end-of-treatment response (55% versus 13% respectively; p = 0.02; odds ratio = 6.07).
  
  
  CONCLUSIONS
  This trial confirms the value of using peginterferon alfa-2a in both naïve and relapsed patients and provides support for a more tailored approach to treatment for relapsers and particulary for patients with a slow viral response.
authors.affiliation: Dienst Interne Geneeskunde Hepatologie,UZ Gasthuisberg KULeuven, Leuven, Belgium. frederik.nevens@uzleuven.be
authors.forename: F
authors.initials: F
authors.lastname: Nevens
authors.forename: H
authors.initials: H
authors.lastname: Van Vlierberghe
authors.forename: E
authors.initials: E
authors.lastname: D'Heygere
authors.forename: J
authors.initials: J
authors.lastname: Delwaide
authors.forename: M
authors.initials: M
authors.lastname: Adler
authors.forename: J
authors.initials: J
authors.lastname: Henrion
authors.forename: A
authors.initials: A
authors.lastname: Lenaerts
authors.forename: A
authors.initials: A
authors.lastname: Hendlisz
authors.forename: P
authors.initials: P
authors.lastname: Michielsen
authors.forename: B
authors.initials: B
authors.lastname: Bastens
authors.forename: R
authors.initials: R
authors.lastname: Brenard
authors.forename: A
authors.initials: A
authors.lastname: Laureys
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; 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