Safety and Efficacy of Pegylated Interferon alpha-2a and Ribavirin Combination in Treatment of Egyptian Patients with Chronic Hepatitis C Genotype-4
Journal Title: IOSR Journal of Pharmacy (IOSRPHR) - Year 2014, Vol 4, Issue 2
Abstract
[b]Introduction:[/b] Egypt has the highest hepatitis C virus (HCV) seroprevalence in the world mostly caused by HCV genotype 4. The standard of care for chronic hepatitis C (CHC) is a combination of pegylated interferon (INF) and ribavirin (RBV). A new locally manufactured pegylated INF with different pegylation chemistry than products with well characterized clinical profiles has been introduced into the Egyptian market with a much lower price. Little is known about the safety and efficacy of this product. So, the aim of this study is to comprehensively evaluate the safety and efficacy of this product. Patients and methods: A total of 97 treatment naïve patients with CHC genotype 4 with mean age 46.68 ± 8.76 years old of whom 79 were males and 18 were females, were treated with pegylated INF alpha-2a and RBV for 48 weeks. Patients were monitored for safety and efficacy during the treatment and 24-week follow up periods. Results: fifty-one (52.58%) patients achieved a sustained virological response (SVR). The rate of SVR varied significantly by age, baseline fibrosis stage, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alpha fetoprotein (AFP), and (WBC). Most adverse effects were mild to moderate in severity and were well tolerated. The overall continuance rate without dose reduction was 37.11%. Three patients discontinued treatment, one died and the others discontinued due to fundal hemorrhage and neutropenia, respectively. Hematologic toxicity included anemia with a frequency 60.82%, neutropenia 4.12%, and thrombocytopenia 1.02%. Conclusion: The efficacy and safety profile of the drug is comparable to previously approved original products. Considering its low cost, it represents an opportunity to fight the HCV epidemic in Egypt at reasonable an affordable costs.
Authors and Affiliations
Abdel-Hameed I. M. Ebid1 , Abdallah Atef Derbala , Ahmed A. Gomaa
Keywords
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