Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus

Safety

On treatment safety, as measured by frequency of serious adverse events (SAEs) and adverse events (AEs), discontinuations due to AEs, and rates and grades of select laboratory abnormalities including liver function tests and hematology laboratory abnormalities in each arm

Time frame: Up to end of treatment (+7 days)

Sustained virologic response

Proportion of treated subjects in each arm with SVR2, SVR4 and SVR 24, defined as HCV RNA \< lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Weeks, 2, 4, and 24 respectively

Time frame: 2, 4 and 24 weeks post-treatment

Post treatment virologic response

To assess the proportion of subjects who achieve sustained virologic response (SVR) 2, SVR4 and SVR24.

Time frame: post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24)

On treatment virologic response

To assess antiviral activity, as measured by the proportion of subjects who achieve HCV RNA \<lower limit of detection (LLOD) and/or \< lower limit of quantification (LLOQ) at each on treatment visit.

Time frame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12

Virologic failure

To assess the proportion of subjects with virologic failure (including on treatment virologic breakthrough and relapse) and evaluate the emergence of viral resistant mutations.