Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry.

Abstract

BACKGROUND & AIMS:

We conducted an open-label phase 2 study to assess the efficacy and safety of the oral nucleotide polymerase inhibitor sofosbuvir in combination with ribavirin in patients of Egyptian ancestry, chronically infected with genotype 4 hepatitis C virus (HCV).

METHODS:

Treatment-naive and previously treated patients with genotype 4 HCV were randomly allocated in a 1:1 ratio to receive sofosbuvir 400mg and weight-based ribavirin, for 12 or 24 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response (HCV RNA <25IU/ml) 12 weeks after cessation of therapy (SVR12).

RESULTS:

Thirty treatment-naive and thirty previously treated patients were enrolled and treated for 12 weeks (n=31) or 24 weeks (n=29). Overall, 23% of patients had cirrhosis and 38% had diabetes. 14% of treatment-naive patients were interferon ineligible and 63% of treatment-experienced patients had prior non-response. SVR12 was achieved by 68% of patients (95% CI, 49-83%) in the 12-week group, and by 93% of patients (95% CI, 77-99%) in the 24-week group. The most common adverse events were headache, insomnia, and fatigue. No patient discontinued treatment due to an adverse event.

CONCLUSIONS:

The findings from the present study suggest that 24 weeks of sofosbuvir plus ribavirin is an efficacious and well tolerated treatment in patients with HCV genotype 4 infection.

• Authors: Peter J Ruane, Dani Ain, Richard Stryker, Raymond Meshrekey, Mina Soliman, Peter R Wolfe, Joseph Riad, Sameh Mikhail, Kathryn Kersey, Deyuan Jiang, Benedetta Massetto, Brian Doehle, Brian J Kirby, Steven J Knox, John G McHutchison, William T Symonds
• Journal: Journal of hepatology (J Hepatol) Vol. 62 Issue 5 Pg. 1040-6 (May 2015) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 25450208 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Chemical References

• Antiviral Agents
• RNA, Viral
• Viral Nonstructural Proteins
• Ribavirin
• NS-5 protein, hepatitis C virus
• RNA-Dependent RNA Polymerase
• Sofosbuvir

Topics

• Adult
• Aged
• Antiviral Agents (administration & dosage, adverse effects)
• Drug Therapy, Combination (methods)
• Egypt
• Female
• Hepacivirus (drug effects, genetics)
• Hepatitis C, Chronic (drug therapy, ethnology, virology)
• Humans
• Male
• Middle Aged
• RNA, Viral (analysis)
• RNA-Dependent RNA Polymerase (antagonists & inhibitors)
• Ribavirin (administration & dosage, adverse effects)
• Sofosbuvir (administration & dosage, adverse effects)
• Treatment Outcome
• United States
• Viral Load (drug effects, methods)
• Viral Nonstructural Proteins (antagonists & inhibitors)