Enhanced efficacy of pegylated interferon alpha-2a over pegylated interferon and ribavirin in chronic hepatitis C genotype 4A randomized trial and qua

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

PEGASYS (Peginterferon alfa-2a), Pegylated Interferon alfa-2b (PEG-INTRON)

Authors: Kamal, Sanaa M.1; Ahmed, Amany1; Mahmoud, Sara1; Nabegh, Leila2; Gohary, Iman El3; Obadan, Isi4; Hafez, Tamer5; Ghoraba, Dahlia1; Aziz, Ahmed A.1; Metaoei, Mona1
Source: Liver International, Volume 31, Number 3, March 2011 , pp. 401-411(11)

Abstract:

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.
Keywords: hepatitis C; pegylated interferon α-2; ribavirin; therapy

Document Type: Research article

DOI: 10.1111/j.1478-3231.2010.02435.x

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: 2011-03-01