Enanta Pharmaceuticals Inc (ENTA)

[NY1972]

Gild triple combo P3

A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

SOF/VEL/GS-9857 (400/100/100 mg) FDC tablet administered orally once daily with food
SOF/VEL (400/100 mg) FDC tablet administered orally once daily without regard to food

Estimated Enrollment: 380
Study Start Date: December 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)