Sofosbuvir/Velpatasvir fixed dose combination in Indian patients with chronic hepatitis c virus (HCV) infection: an open-label, single-arm, multicenter phase IV study

Abstract

Background: This Phase IV post-marketing study was conducted to demonstrate the safety and efficacy of sofosbuvir/velpatasvir fixed-dose combination (FDC) in adult Indian patients with HCV infection as per the recommendation of the Drugs Controller General (India). Methods: This single-arm, open-label, multicenter study was conducted across 22 sites in 409 patients in India. All the eligible patients received once-daily sofosbuvir/velpatasvir (400mg/100mg) FDC for 12weeks. Safety was assessed by monitoring the adverse events (AEs) and efficacy was measured by the proportion of patients achieving sustained virological response (HCV RNA <15 IU/mL or undetectable) at 12weeks after the end of the treatment (SVR12). Results: Between October 2018 to June 2020, 409 patients were enrolled. Twenty patients discontinued the study due to consent withdrawal or lost to follow-up. The SVR12 rate was 90.8%. Sensitivity analysis showed consistent results with SVR12 rates of more than 93%. The combination was well tolerated and none of the AEs reported were related to the study drug, requiring dose reduction, or discontinuation of the study treatment. Conclusions: Once daily sofosbuvir/velpatasvir FDC for 12 weeks was found to be safe, well tolerated, and effective in patients with HCV infection. Trial Registration: The trial is registered at clinical trial registry of India with registration number CTRI/2018/08/015359. (CTRI Trial Data)