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A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection

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Trial Profile

A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2021

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At a glance

Most Recent Events

  • 20 Dec 2019 According to an Gilead Sciences media release, the China National Medical Products Administration (NMPA) has approved Vosevi for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy. The approval of Vosevi in China is supported by POLARIS-1 and POLARIS-4 studies.
  • 27 Mar 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
  • 01 Oct 2018 Results of a pooled analysis assessing patients reported outcomes from 11 studies, published in the Value in Health.

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