Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis

Summary

A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis The primary objectives of this study are as follows: * To evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12). * To evaluate the safety and tolerability of EBV/GZR treatment The secondary objectives of this study are as follows: * To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) * To evaluate the proportion of subjects with virologic failure * To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment. * To evaluate the emergence of viral resistance to EBV/GZR during treatment and after cessation of treatment

Timeline

Start

2017-01-11

Primary completion

2018-11-10

Completion

2019-04

Drugs

Indications