A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naive Subjects With Chronic HCV Infection

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 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naive Subjects With Chronic HCV Infection

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2018

At a glance

  • Drugs Sofosbuvir/velpatasvir/voxilaprevir (Primary) ; Sofosbuvir/velpatasvir
  • Indications Hepatitis C
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms POLARIS-2
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 05 Dec 2017 Results of resistance analysis in HCV infected patients Genotype 1-6 from phase III studies (ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-5 and POLARIS-2, POLARIS-3; n=1778) published in the Journal of Hepatology
    • 27 Nov 2017 Results assessing patient-reported outcomes from POLARIS 2 and 3 (n=1160) published in the Alimentary Pharmacology and Therapeutics
    • 28 Jul 2017 According to a Gilead Sciences media release, based on the data from POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4 studies, the European Commission has granted marketing authorization for Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
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