A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis
Latest Information Update: 01 Jan 2024
At a glance
- Drugs Sofosbuvir/velpatasvir (Primary) ; Ribavirin
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Gilead Sciences
- 14 Nov 2023 Results (n=99) assessing long-term survival and hepatocellular carcinoma development in Hepatitis C virus patients with decompensated cirrhosis after direct-acting antiviral treatment presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
- 08 Jan 2019 Results published in the Gilead Sciences Media Release
- 08 Jan 2019 Based on the data from this trial, the Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg), a once-daily treatment for adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis, and for patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral therapy (DAA).