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
Phase of Trial: Phase III
Latest Information Update: 17 Aug 2017
At a glance
- Drugs Sofosbuvir/velpatasvir/voxilaprevir (Primary)
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms POLARIS-1
- Sponsors Gilead Sciences
- 17 Aug 2017 According to a Gilead Sciences media release, based on data from the POLARIS-1 and POLARIS-4 trials, Health Canada has granted a Notice of Compliance for VOSEVI (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets.
- 28 Jul 2017 According to 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.
- 18 Jul 2017 According to a Gilead Sciences media release, based on the data from POLARIS-1 and POLARIS-4 studies the U.S. FDA has approved Vosevi, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History