Sofosbuvir-velpatasvir with ribavirin for 24 weeks in HCV patients previously treated with a direct-acting antiviral regimen

The optimal retreatment strategy for patients chronically infected with hepatitis C virus (HCV) who experience virologic failure after treatment with direct-acting antiviral (DAA)-based therapies remains unclear. In this multicenter, open-label, phase 2 study, we evaluated the efficacy and safety of a fixed-dose combination of sofosbuvir-velpatasvir (400 mg/100 mg) plus weight-adjusted ribavirin administered for 24 weeks in patients who did not achieve sustained virologic response (SVR) after prior treatment with DAA regimens that included the nucleotide analogue NS5B inhibitor sofosbuvir plus the NS5A inhibitor velpatasvir with or without the NS3/4A protease inhibitor voxilaprevir. The primary efficacy endpoint was the proportion of patients achieving SVR at 12 weeks after the cessation of treatment. In total, 63 of 69 (91%; 95% confidence interval [CI], 82-97%) patients achieved SVR12, including 36 of 37 (97%; 95% CI, 86-100%) patients with HCV genotype 1 infection, 13 of 14 (93%; 95% CI, 66-100%) patients with genotype 2 infection, and 14 of 18 (78%; 95% CI, 52-94%) patients with genotype 3 infection. Most adverse events were of mild or moderate severity. The most frequently reported adverse events were fatigue, nausea, headache, insomnia, and rash. One patient (1%) with genotype 1a infection discontinued all treatment due to an adverse event (irritability). Conclusion: Retreatment of patients who previously failed DAA-based therapies with sofosbuvir-velpatasvir plus ribavirin for 24 weeks was well tolerated and effective, particularly those with HCV genotype 1 or 2 infection. This article is protected by copyright. All rights reserved.