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

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-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.

• Authors: Wahid Doss, Gamal Shiha, Mohamed Hassany, Reham Soliman, Rabab Fouad, Marwa Khairy, Waleed Samir, Radi Hammad, Kathryn Kersey, Deyuan Jiang, Brian Doehle, Steven J Knox, Benedetta Massetto, John G McHutchison, Gamal Esmat
• Journal: Journal of hepatology (J Hepatol) Vol. 63 Issue 3 Pg. 581-5 (Sep 2015) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 25937436 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 European Association for the Study of the Liver. All rights reserved.

Chemical References

• Antiviral Agents
• Ribavirin
• Sofosbuvir

Topics

• Adult
• Aged
• Antiviral Agents (administration & dosage)
• Drug Therapy, Combination
• Female
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (drug therapy, virology)
• Humans
• Male
• Middle Aged
• Ribavirin (administration & dosage, adverse effects)
• Sofosbuvir (administration & dosage, adverse effects)