Sofosbuvir/GS-5816 Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis (ASTRAL-4) phase 3
This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Gilead Sciences
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/GS-5816 FDC for 24 weeks in adults with hepatitis C virus (HCV) infection and Child-Pugh (CPT) class B cirrhosis.
Participants with cirrhosis and moderate hepatic impairment (CPT Class B) will be randomized to receive either 12 or 24 weeks of LDV/SOF FDC plus RBV.
Participants with cirrhosis and severe hepatic impairment (CPT Class C) will be randomized to receive either 12 or 24 weeks of LDV/SOF FDC plus RBV.