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

Liver Int. 2011 Mar;31(3):401-11. doi: 10.1111/j.1478-3231.2010.02435.x. Epub 2011 Jan 11.


Aim: 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.

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT00502099.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Activities of Daily Living
  • Adult
  • Antiviral Agents / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Health Status
  • Hepacivirus / classification
  • Hepacivirus / drug effects*
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / blood
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / virology
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / therapeutic use*
  • Male
  • Polyethylene Glycols / therapeutic use*
  • Quality of Life
  • RNA, Viral / blood
  • Recombinant Proteins
  • Ribavirin / therapeutic use*
  • Viral Load / drug effects


  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • RNA, Viral
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • peginterferon alfa-2a

Associated data

  • ClinicalTrials.gov/NCT00502099