Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4

• Published in: Journal of hepatology Vol. 63; no. 3; pp. 581 - 585
• Main Authors: Doss, Wahid, Shiha, Gamal, Hassany, Mohamed, Soliman, Reham, Fouad, Rabab, Khairy, Marwa, Samir, Waleed, Hammad, Radi, Kersey, Kathryn, Jiang, Deyuan, Doehle, Brian, Knox, Steven J, Massetto, Benedetta, McHutchison, John G, Esmat, Gamal
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-09-2015
• Subjects: Adult; Aged; Antiviral agents; Antiviral Agents - administration & dosage; Drug Therapy, Combination; Egypt; Female; Gastroenterology and Hepatology; Genotype; Genotype 4; Hepacivirus - genetics; Hepatitis C; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; Male; Middle Aged; Polymerase inhibitor; Ribavirin - administration & dosage; Ribavirin - adverse effects; Sofosbuvir; Sofosbuvir - administration & dosage; Sofosbuvir - adverse effects; LLOQ; Antiviral agents; AST; body mass index; Egypt; alanine aminotransferase; ALT; SVR; aspartate aminotransferase; Genotype 4; upper limit of normal; ULN; sustained virological response; hepatitis C virus; HCV; lower limit of quantification; Hepatitis C; Polymerase inhibitor; Sofosbuvir; BMI
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/j.jhep.2015.04.023

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-naïve or treatment-experienced patients with genotype 4 HCV infection (n = 103) were randomly assigned to receive either 12 or 24 weeks of sofosbuvir 400 mg and ribavirin 1000–1200 mg 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 <25 IU/ml 12 weeks after therapy (SVR12). Results Among all patients, 52% had received prior HCV treatment and 17% had cirrhosis at baseline. SVR12 rates were 90% (46/51) with 24 weeks and 77% (40/52) with 12 weeks of sofosbuvir and ribavirin therapy. Patients with cirrhosis at baseline had lower rates of SVR12 (63% 12 weeks, 78% 24 weeks) than those without cirrhosis (80% 12 weeks, 93% 24 weeks). 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 24 weeks is effective in treating both treatment-naïve and treatment-experienced Egyptian patients with genotype 4 HCV.