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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jan 2024

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At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 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).

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