Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study

This prospective, randomized, phase 2 study in subjects with recurrent hepatitis C virus (HCV) genotype 1 post-orthotopic liver transplant evaluated once-daily simeprevir 150mg+sofosbuvir 400mg, with and without ribavirin 1,000mg. Primary endpoint was proportion of subjects with Week 12 sustained virologic response (SVR12). Thirty-three subjects without cirrhosis were randomized 1:1:1 into three arms (stratified by geno/subtype and Q80K): Arm 1, simeprevir+sofosbuvir+ribavirin, 12 weeks; Arm 2, simeprevir+sofosbuvir, 12 weeks; Arm 3, simeprevir+sofosbuvir, 24 weeks; 13 additional subjects (2 with cirrhosis, 11 without cirrhosis) entered Arm 3. All 46 subjects received at least one dose of study drug; median age, 60 years; 73.9% male; 80.4% white; 71.7% geno/subtype 1a (12 [36.4%] of these had Q80K); median 4.5 years post-transplant. Among randomized subjects, SVR12 was achieved by 81.8% in Arm 1, 100% in Arm 2, and 93.9% in Arm 3; two subjects did not achieve SVR12: one viral relapse (follow-up Week 4; Arm 1) and one missing follow-up Week 12 data. In total, five subjects had a serious adverse event, considered unrelated to treatment per investigator. Simeprevir exposure was increased relative to the non-transplant setting, but not considered clinically relevant. Simeprevir+sofosbuvir treatment, with or without ribavirin, was efficacious and well tolerated (ClinicalTrials. gov Identifier: NCT02165189) This article is protected by copyright. All rights reserved.