An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection

Summary

The purpose of this study is to evaluate the efficacy of simeprevir in combination with sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in the overall population.

Timeline

Start

2014-12

Primary completion

2015-10

Completion

2015-10

Publications

• El Raziky M, Gamil M, Ashour MK, Sameea EA, Doss W, Hamada Y, Van Dooren G, DeMasi R, Keim S, Lonjon-Domanec I, Hammad R, Hashim MS, Hassany M, Waked I. Simeprevir plus sofosbuvir for eight or 12 weeks in treatment-naive and treatment-experienced hepatitis C virus genotype 4 patients with or without cirrhosis. J Viral Hepat. 2017 Feb;24(2):102-110. doi: 10.1111/jvh.12625. Epub 2016 Oct 27.

Drugs

Indications