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A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

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Trial Profile

A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Dec 2022

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At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary) ; Sofosbuvir/velpatasvir/voxilaprevir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms POLARIS-4
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 08 Nov 2022 Results of post-hoc analysis of Phase 3 trials with SOF/VEL 12 weeks without ribavirin (RBV) (ASTRAL 1-5, and POLARIS4) presented at The Liver Meeting 2022: 73rd Annual Meeting of the American Association for the Study of Liver Diseases
    • 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.
    • 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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