Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Summary

The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.

Timeline

Start

2015-01

Primary completion

2015-12

Completion

2015-12

Publications

• Buti M, Calleja JL, Lens S, Diago M, Ortega E, Crespo J, Planas R, Romero-Gomez M, Rodriguez FG, Pascasio JM, Fevery B, Kurland D, Corbett C, Kalmeijer R, Jessner W. Simeprevir in combination with sofosbuvir in treatment-naive and -experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open-label, single-arm study (PLUTO). Aliment Pharmacol Ther. 2017 Feb;45(3):468-475. doi: 10.1111/apt.13883. Epub 2016 Nov 29.

Drugs

Indications