1. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4
- Author
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Gamal Shiha, W. Samir, Steven J. Knox, Kathryn Kersey, Radi Hammad, Gamal Esmat, Deyuan Jiang, Brian P. Doehle, Rabab Fouad, Wahid Doss, Reham Soliman, John G. McHutchison, Benedetta Massetto, Mohamed Hassany, and Marwa Khairy
- Subjects
Adult ,Male ,medicine.medical_specialty ,Cirrhosis ,Genotype ,Sofosbuvir ,Anemia ,Hepatitis C virus ,Hepacivirus ,medicine.disease_cause ,Antiviral Agents ,Gastroenterology ,chemistry.chemical_compound ,Internal medicine ,Ribavirin ,medicine ,Humans ,Adverse effect ,Aged ,Hepatology ,business.industry ,virus diseases ,Hepatitis C ,Hepatitis C, Chronic ,Middle Aged ,medicine.disease ,digestive system diseases ,Discontinuation ,chemistry ,Immunology ,Drug Therapy, Combination ,Female ,business ,medicine.drug - Abstract
Background & Aims Egypt has the highest prevalence of chronic hepatitis C virus (HCV) infection in the world, and more than 90% of patients are infected with genotype 4 virus. We evaluated the efficacy and safety of the HCV polymerase inhibitor sofosbuvir in combination with ribavirin in HCV genotype 4 patients in Egypt. Methods Treatment-naive or treatment-experienced patients with genotype 4 HCV infection (n=103) were randomly assigned to receive either 12 or 24weeks of sofosbuvir 400mg and ribavirin 1000–1200mg daily. Randomization was stratified by prior treatment experience and by presence or absence of cirrhosis. The primary endpoint was the percentage of patients with HCV RNA Results Among all patients, 52% had received prior HCV treatment and 17% had cirrhosis at baseline. SVR12 rates were 90% (46/51) with 24weeks and 77% (40/52) with 12weeks of sofosbuvir and ribavirin therapy. Patients with cirrhosis at baseline had lower rates of SVR12 (63% 12weeks, 78% 24weeks) than those without cirrhosis (80% 12weeks, 93% 24weeks). The most common adverse events were fatigue, headache, insomnia, and anemia. Two patients experienced serious adverse events (cerebral ischemia, dyspnea). No adverse events resulted in treatment discontinuation. Conclusion Sofosbuvir plus ribavirin for 12 or 24weeks is effective in treating both treatment-naive and treatment-experienced Egyptian patients with genotype 4 HCV.
- Published
- 2015