title: Efficacy and safety of two-dose regimens of peginterferon alpha-2a compared with interferon alpha-2a in chronic hepatitis C: a multicenter, randomized controlled trial.
abstract: OBJECTIVE
  This study compared the efficacy and safety of peginterferon alpha-2a 135 microg/wk, peginterferon alpha-2a 180 microg/wk and interferon alpha-2a in patients with chronic hepatitis C.
  
  
  METHODS
  A total of 639 patients received peginterferon alpha-2a 135 microg or 180 microg once weekly, or interferon alpha-2a 3 MIU thrice weekly for 48 wk.
  
  
  RESULTS
  Sustained virological responses were significantly higher with peginterferon alpha-2a than with interferon alpha-2a 3 MIU (28% in the 135 microg and 180 microg peginterferon alpha-2a groups vs 11% with interferon alpha-2a, p = 0.001). The proportion of patients with clinically significant histological improvement was lower in the peginterferon alpha-2a 135 microg (48%) than the 180 microg group (58%, p = 0.035 vs peginterferon alpha-2a 135 microg), but similar to that in the interferon alpha-2a group (45%, p = 0.820 vs peginterferon alpha-2a 135 microg and p = 0.017 vs peginterferon alpha-2a 180 microg, respectively). The overall safety profiles were similar for the three treatments. In patients with chronic hepatitis C, peginterferon alpha-2a 135 microg/wk and 180 microg/wk produced similar sustained virological response rates, both of which were significantly higher than that achieved with interferon alpha-2a thrice weekly. A significantly higher proportion of patients treated with the 180 microg dose of peginterferon alpha-2a had clinically significant histological improvement.
authors.affiliation: Division of Gastroenterology/Hepatology, Scripps Clinic, La Jolla, California 92037, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Pockros
authors.forename: Robert
authors.initials: R
authors.lastname: Carithers
authors.forename: Paul
authors.initials: P
authors.lastname: Desmond
authors.forename: Daniel
authors.initials: D
authors.lastname: Dhumeaux
authors.forename: Michael W
authors.initials: MW
authors.lastname: Fried
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.forename: Mitchell L
authors.initials: ML
authors.lastname: Shiffman
authors.forename: Gerald
authors.initials: G
authors.lastname: Minuk
authors.forename: K Rajender
authors.initials: KR
authors.lastname: Reddy
authors.forename: Robert W
authors.initials: RW
authors.lastname: Reindollar
authors.forename: Amy
authors.initials: A
authors.lastname: Lin
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Brunda
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins; D012449:Safety
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a