Abstract

Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection. In this single-arm, open-label, phase 3, deferred treatment study we investigated the efficacy and safety of sofosbuvir-velpatasvir among patients randomized to the placebo group in the ASTRAL-1 study. Patients received sofosbuvir-velpatasvir (400/100 mg) once daily for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response 12 weeks after the end of therapy (SVR12). The primary safety endpoint was any adverse events (AEs) leading to the permanent discontinuation of study drug. Overall, 108/111 (97%, 95% confidence interval [CI], 92-99%) achieved SVR12, and only one patient had virological failure. SVR12 was achieved by 61/63 (97%, 95%CI, 89-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83-100%) with genotype 2, 19/19 (100%; 95%CI, 82-100%) with genotype 4, and 8/9 (89%; 95% CI, 52-100%) with genotype 6. All (19/19; 95%CI, 82-100) patients with cirrhosis, and all (31/31, 95%CI, 89-100) with prior treatment experience achieved SVR12.The safety profile during treatment was similar to that observed in patients receiving placebo treatment. The most common AEs were headache, fatigue, and nausea. One patient (1%) discontinued treatment due to an AE of gallbladder carcinoma, which was not considered related to treatment. Of five reported serious AEs, none were considered related to study drug. Sofosbuvir-velpatasvir for 12 weeks was effective and well-tolerated among untreated and previously treated patients with HCV genotype 1, 2, 4, or 6 infection, including those with compensated cirrhosis. This article is protected by copyright. All rights reserved.

View details for DOI 10.1111/jvh.13159

View details for PubMedID 31216086