Sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in genotype 1, 2, 4, 5, 6 HCV patients: ASTRAL-1 study

Abstract

INTRODUCTION: Velpatasvir (VEL) is a pangenotypic HCV-NS5A inhibitor. This Phase 3 study evaluated treatment with a fixed dose combination of SOF/VEL for 12 weeks in patients with genotype 1, 2, 4, 5, or 6 HCV infection. METHODS: Patients with genotype 1, 2, 4, or 6 chronic HCV infection were randomized 5:1 to received SOF/VEL (400 mg /100 mg daily) or placebo for 12 weeks. Patients with genotype 5 infection were enrolled to the SOF/VEL treatment group and patients with genotype 3 were evaluated in a separate study. RESULTS: 740 patients were enrolled at 81 international sites: 60 % male, 79 % white, 32 % treatment-experienced (TE), and 19 % compensated-cirrhosis. Of the 624 patients treated with SOF/VEL, the genotype distribution was 53 % GT1, 17 % GT2, 19 % GT4, 6 % GT5 and 7 % GT6. Overall SVR12 for SOF/VEL-treated patients was 99.0 % and the study met its primary efficacy endpoint. SVR12 rates by HCV genotype are presented in the table. Two of 328 patients (0.6 %) with genotype-1 infection had virologic relapse. No patients with genotype 2, 4, 5, or 6, including 48 with cirrhosis, had virologic failure. Four patients did not achieve SVR12 for non-virologic reasons. AEs and laboratory abnormalities were similar in the SOF/VELS12 treated patients compared with the 116 placebo-treated patients. One patient discontinued SOF/VEL treatment due to adverse-events. CONCLUSIONS: Treatment with the once daily, all-oral, single tablet regimen of SOF/VEL for 12 weeks is well tolerated and results in high SVR12 rates in treatment-naı¨ve and treatment-experienced genotype 1,2,4,5,6 HCV-infected patients with and without cirrhosis.