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

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