Polaris 2
Research type
Research Study
Full title
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-Naïve Subjects with Chronic HCV Infection
IRAS ID
191042
Contact name
Graham Foster
Contact email
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2015-003460-36
Duration of Study in the UK
1 years, 0 months, 17 days
Research summary
Hepatitis C virus (HCV) infection is a global health challenge with an estimated 150 million individuals infected worldwide. HCV primarily affects the liver and can cause liver cirrhosis leading onto liver failure or liver cancer.
There are 7 major genotypes (genetic variations) of HCV; there is no current standard of care treatment for all genotypes. A therapy that avoids the costs and delays of having to assess the HCV genotype would facilitate therapy and reduce treatment cost.
Recently, the development of oral direct-acting antivirals (DAAs) has provided a major advance in the treatment of HCV. However, there are a growing number of patients who do not respond to DAA-based therapies and this patient population currently has no retreatment options.
SOF/VEL/GS-9857 FDC (fixed dose combination) is a combined formulation in a single tablet for the treatment of chronic HCV infection. This combines three mechanisms of action:
• Sofosbuvir (SOF), an NS5B polymerase inhibitor, is currently approved in the US and other regions for the treatment of HCV infection as a component of combined treatment.
• Velpatasvir (VEL), an NS5A inhibitor that has in vitro anti-HCV activity across all genotypes, which is currently being evaluated in four Phase 3 studies as a combined tablet with SOF.
• GS-9857, a new NS3/4A protease inhibitor with potent in vitro antiviral activity against genotypes 1 to 6 HCV.This study aims to enrol approximately 780 participants aged over 18 diagnosed with chronic HCV who have not previously been treated with DAAs. The study will take place at approximately 120 centres in the US, Canada, New Zealand, Australia, France, Germany and the UK. This study will compare the effectiveness of treatment with SOF/VEL/GS-9857 FDC for 8 weeks with that of SOF/VEL FDC for 12 weeks in patients with chronic HCV of all genotypes.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0185
Date of REC Opinion
9 Dec 2015
REC opinion
Further Information Favourable Opinion