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

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‐relat...

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Bibliographic Details
Published in:Liver international 2011-03, Vol.31 (3), p.401-411
Main Authors: Kamal, Sanaa M., Ahmed, Amany, Mahmoud, Sara, Nabegh, Leila, Gohary, Iman El, Obadan, Isi, Hafez, Tamer, Ghoraba, Dahlia, Aziz, Ahmed A., Metaoei, Mona
Format: Article
Language:English
Subjects:
Activities of Daily Living
Adult
Antiviral Agents - therapeutic use
Clinical trials
Drug Therapy, Combination
Female
Genotypes
Health Status
Hepacivirus - classification
Hepacivirus - drug effects
Hepacivirus - genetics
Hepatitis C
Hepatitis C virus
Hepatitis C, Chronic - blood
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
Humans
Interferon
Interferon-alpha - therapeutic use
Inventories
Liver diseases
Male
pegylated interferon α-2
Polyethylene Glycols - therapeutic use
Quality of Life
Recombinant Proteins
Ribavirin
Ribavirin - therapeutic use
RNA
RNA, Viral - blood
therapy
Viral Load - drug effects
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Summary: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.
ISSN:1478-3223
1478-3231
DOI:10.1111/j.1478-3231.2010.02435.x