title: Enhanced efficacy of pegylated interferon alpha-2a over pegylated interferon and ribavirin in chronic hepatitis C genotype 4A randomized trial and quality of life analysis.
abstract: OBJECTIVE
  The therapy of chronic hepatitis C genotype 4 (HCV-4) has not been optimized yet. This randomized, prospective, parallel-group clinical trial compared the efficacy and safety of pegylated interferon α-2a (PEG-IFN α-2a) plus ribavirin and PEG-IFN α-2b plus ribavirin and assessed the health-related quality of life (HRQOL) in patients with chronic HCV-4.
  
  
  METHODS
  Eligible patients with proven chronic HCV-4 were randomized to receive either a weekly dose of PEG-IFN α-2a (180 μg) or PEG-IFN α-2b (1.5 μg/kg) and a daily dose of ribavirin (1000-1200 mg) for 48 weeks with 24 weeks post-treatment follow-up. The primary end point was sustained virological response (SVR) defined by undetectable HCV RNA 24 weeks after treatment. The Short form-36 Health Survey version 2 (SF-36v2) and the Chronic Liver Disease questionnaires (CLDQ) were assessed before, during and after therapy.
  
  
  RESULTS
  The overall SVR rate of the entire cohort was 59.9%. The SVR rates were significantly higher in patients treated with PEG-IFN α-2a and ribavirin (Group A; n=109) compared with those treated with PEG-IFN α-2b and ribavirin (Group B; n=108, 70.6 vs. 54.6%, respectively; P=0.017). The relapse rates were 5.1% for PEG-IFN α-2a and 15.7% for PEG-IFN α-2b (P=0.0019). The SF-36v2 and CLDQ were low during therapy and improved significantly after therapy successful therapy.
  
  
  CONCLUSIONS
  Pegylated interferon α-2a plus ribavirin was significantly more effective than PEG-IFN α-2b and ribavirin therapy in the treatment of chronic HCV-4 patients. The tolerability and adverse events were comparable between the two regimens. The HRQOL improved significantly after successful PEG-IFN α-2a plus ribavirin therapy.
authors.affiliation: Department of Hepatology, Infectious Diseases and Tropical Medicine, Ain Shams Faculty of Medicine, University of Ain Shams, Cairo, Egypt. sanaakamal@comcast.net
authors.forename: Sanaa M
authors.initials: SM
authors.lastname: Kamal
authors.forename: Amany
authors.initials: A
authors.lastname: Ahmed
authors.forename: Sara
authors.initials: S
authors.lastname: Mahmoud
authors.forename: Leila
authors.initials: L
authors.lastname: Nabegh
authors.forename: Iman
authors.initials: I
authors.lastname: El Gohary
authors.forename: Isi
authors.initials: I
authors.lastname: Obadan
authors.forename: Tamer
authors.initials: T
authors.lastname: Hafez
authors.forename: Dahlia
authors.initials: D
authors.lastname: Ghoraba
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Aziz
authors.forename: Mona
authors.initials: M
authors.lastname: Metaoei
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006304:Health Status; D016174:Hepacivirus / Q000145:classification / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011788:Quality of Life; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D019562:Viral Load / Q000187:drug effects
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