Yang – Employment: Gilead Sciences, Inc Yanni Zhu – Employment: Gilead Sciences, Inc.; Y-27632 Stock Shareholder: Gilead Sciences, Inc. Robert H. Hyland – Employment: Gilead Sciences, Inc; Stock Shareholder: Gilead Sciences, Inc Phillip S. Pang – Employment: Gilead Sciences John G. McHutchison – Employment: Gilead Sciences; Stock Shareholder: Gilead Sciences K. Rajender Reddy – Advisory Committees or Review Panels: Genentech-Roche, Merck, Janssen,

Vertex, Gilead, BMS, Novartis, Abbvie; Grant/Research Support: Merck, BMS, Ikaria, Gilead, Janssen, AbbVie Patrick Marcellin – Consulting: Roche, Gilead, BMS, Vertex, Novartis, Janssen, MSD, Abbvie, Alios BioPharma, Idenix, Akron; Grant/Research Support: Roche, Gilead, BMS, Novartis, Janssen, MSD, Alios BioPharma; Speaking and Teaching: Roche, Gilead, BMS, Vertex, Novartis, Janssen, MSD, Boehringer, Pfizer, Abbvie Background: The IFN-free, all oral combination of the protease inhibitor FDV 120 mg QD, the non-nucleoside polymerase inhibitor DBV 600 mg BID, and weight-based RBV was evaluated in HCV GT-1b infected treatment-naïve patients. Methods:

A randomized, blinded comparison of 16 weeks (w) (Arm 1; N=208) vs 24w (Arm 2; N=211) of FDV+DBV+RBV Roxadustat clinical trial in patients without cirrhosis, and an open-label assessment of FDV+DB-V+RBV for 24w in patients with compensated cirrhosis (Arm 3; N=51). Matching placebo was used from 16–24w in Arm 1. Primary endpoints: SVR12 with 16 vs 24w regimens (Arm 1 vs 2); and comparison with historical SVR rate of 71% (available DAAs at study start; SVR12 rates were adjusted by proportions of cirrhotic patients in comparable trials in each arm).

Results: A total of 470 patients were treated (male 46%, white 90%, IL28B CC 24%, F3 18% [Arms 1 and 2]). A greater proportion of patients in Arm 2 (24w) achieved SVR12 (82%) than in Arm 1 (16w) (72%) (Table, difference estimate 10.8, 95%CI 2.818.8, p=0.004); 73% of patients in Arm 3 achieved SVR12. Relapse occurred in 23/175 (13%), 3/167 (2%), and 2/37 (5%) patients and on-treatment virologic failure occurred in 15 (7%), 20 (9%), and 7 (14%) patients in Arms 1, 2, and 3, respectively. Adjusted response rates were 81% after 24w (95%CI 77–86, p<0.0001 selleckchem vs historical control) and 72% after 16w of treatment (95%CI 66-77, p=0.3989 vs historical control). Rash and photosensitivity, mostly mild, each occurred in 20% of all patients. The most frequent adverse events (AEs) of at least moderate intensity (>10% in any arm) were nausea, diarrhea, asthenia, and anemia. Severe/life-threatening AEs were reported in 18% of all patients. Overall, AEs were similar for Arms 1 and 2. Discontinuation of all medications due to AEs occurred in 8% of patients across all arms. Grade 3/4 bil-irubin elevations (mostly unconjugated) occurred in 52% of all patients.