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
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 g) or PEG-IFN α-2b (1.5 g/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.
Document Type: Research Article
Affiliations: 1: Department of Hepatology, Infectious Diseases and Tropical Medicine, Ain Shams Faculty of Medicine, University of Ain Shams, Cairo, Egypt 2: Department of Pathology, Ain Shams Faculty of Medicine, University of Ain Shams, Cairo, Egypt 3: Department of Clinical Pathology Ain Shams Faculty of Medicine, University of Ain Shams, Cairo, Egypt 4: Department of Biostatistics and Informatics, Tufts School of Medicine, Tufts University, Boston, MA, USA 5: Department of Biology, Division of Microbiology, The American University in Cairo, Cairo, Egypt
Publication date: March 1, 2011