Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Summary

The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Timeline

Start

2015-09-07

Primary completion

2016-11-11

Completion

2017-02-04

Publications

• Results Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China
• Shiha G, Esmat G, Hassany M, Soliman R, Elbasiony M, Fouad R, Elsharkawy A, Hammad R, Abdel-Razek W, Zakareya T, Kersey K, Massetto B, Osinusi A, Lu S, Brainard DM, McHutchison JG, Waked I, Doss W. Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt. Gut. 2019 Apr;68(4):721-728. doi: 10.1136/gutjnl-2017-315906. Epub 2018 Apr 17.

Drugs

Indications