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: 28 Jul 2017

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

    • 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.
    • 23 Jun 2017 According to a Gilead Sciences media release, the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act of August 8, 2017 for the New Drug Application for SOF/VEL/VOX .
    • 23 Jun 2017 According to a Gilead Sciences media release, based on the data from POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4 studies the Committee for Medicinal Products for Human Use (CHMP), has adopted a positive opinion on the Marketing Authorization Application (MAA) for Vosevi, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.
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