GT EVERSON,1 KD SIMS,2 M RODRIGUEZ-TORRES,3 C HÉZODE,4 E LAWITZ,5 M BOURLIÈRE,6 V LOUSTAUD-RATTI,7 V RUSTGI,8 H SCHWARTZ,9 H TATUM,10 P MARCELLIN,11 S POL,12 PJ THULUVATH,13 T ELEY,2 X WANG,2 SP HUANG,14 F MCPHEE,15 M WIND-ROTOLO,14 E CHUNG,2 C PASQUINELLI,2 DM GRASELA,2 DF GARDINER2

1University of Colorado Denver, Aurora, CO, USA, 2Bristol-Myers Squibb, Hopewell, NJ, USA, 3Fundación de Investigación, San Juan, Puerto Rico, 4CHU Henri Mondor, Service d’Hépato-Gastroentérologie, Créteil, France, 5Alamo Medical Research, San Antonio, TX, USA, 6Hôpital Saint Joseph, Service d’Hépato-Gastroentérologie, Marseille, France, 7University Hospital of Limoges, Limoges, France, 8Metropolitan Research, Arlington, VA, USA, 9Miami Research Associates, South Miami, FL, USA, 10Options Health Research, Tulsa, OK, USA,

11Hôpital Beaujon, Clichy, France, 12Université Paris Descartes, PD-0332991 nmr INSERM U1610 and Liver Unit, Hôpital Cochin, Ivacaftor Paris, France, 13Mercy Medical Center, Baltimore, MD, USA, 14Bristol-Myers Squibb, Princeton, NJ, USA, 15Bristol-Myers Squibb, Wallingford, CT, USA Introduction: The IFN- and RBV-free regimen of DCV (NS5A inhibitor), ASV (NS3 protease inhibitor) and BMS-791325 (non-nucleoside NS5B polymerase inhibitor, 75 mg BID) for 24 or 12 weeks was well tolerated and achieved SVR4 and SVR12 >90% in treatment-naïve, hepatitis C virus (HCV) genotype (GT) 1 patients. We present safety and SVR following 24 or 12 weeks of this treatment using two BMS-791325 doses (75 vs 150 mg BID). Methods: This phase 2 study randomized treatment-naive, HCV GT1, non-cirrhotic patients (N = 32) 1 : 1 to DCV 60 mg QD, ASV 200 mg BID, and BMS-791325 75 mg BID for 24 (Group 1) or 12 (Group 2) weeks. Following safety evaluation, 34 additional patients were randomized to DCV, ASV, and BMS-791325 150 mg BID for 24 (Group 3) or 12 (Group 4) weeks. The primary end point was HCV

RNA <25 IU/mL at 12 weeks post-treatment (SVR12). Safety and SVR from Groups 1 (SVR12), 2 (SVR24) and 4 (SVR4) are MCE described, Groups 3 (SVR4) and 4 (SVR12) will be presented. Results: Patients were mainly GT1a (74%), white race (79%), and IL28B non-CC (70%). 64 of 66 patients had HCV RNA <25 IU/mL by Week 4 (Table 1). In this interim analysis, there was no difference in virologic responses between 12 and 24 weeks of treatment (Table 1). Overall, patients achieved SVR4 92% (46/50), SVR12 94% (30/32), and SVR24 94% (15/16). Three failures (Groups 3–4) were observed in patients receiving BMS-791325 150 mg (2-viral breakthrough, 1-relapse). No patients discontinued due to adverse events (AEs) related to DCV+ASV+BMS-791325. Most common AEs (≥10% total) were headache, asthenia, and gastrointestinal. Two serious AEs have been reported, both unrelated to DCV+ASV+BMS-791325. No hepatotoxicity or Grade 3/4 elevations of ALT/AST or bilirubin were reported.