Polaris 3
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 and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects with Chronic Genotype 3 HCV Infection and Cirrhosis
IRAS ID
193753
Contact name
Graham Foster
Contact email
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2015-002996-12
Duration of Study in the UK
0 years, 11 months, 23 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 cirrhosis leading onto liver failure or cancer.
It has been shown that combination regimens containing three Direct-Activing Antivirals (DAAs) that have activity against strains of HCV with resistance to certain medications, may allow an 8 or 12 week treatment period that is well tolerated by participants with genotype 3 HCV and cirrhosis, whilst continuing to maintain safety and potentially improve effectiveness (efficacy).
This study aims to enrol approximately 200 participants aged over 18 with chronic HCV genotype 3 and cirrhosis who have not previously been treated with DAAs. The study will take place at approximately 120 centres in the UK, US, Canada, New Zealand, Australia, France and Germany.
This study will compare the effectiveness of treatment with SOF/VEL/GS-9857 FDC (fixed dose combination) for 8 weeks with that of SOF/VEL FDC for 12 weeks in patients with chronic HCV genotype 3 with liver cirrhosis.
SOF/VEL/GS-9857 FDC is a combined formulation in a single tablet that combines three mechanisms of action:
• Sofosbuvir (SOF), an NS5B polymerase inhibitor, currently approved in the US and other regions for 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, currently being evaluated in four clinical studies as a combined tablet with SOF.
• GS-9857, a new NS3/4A protease inhibitor with antiviral activity against genotypes 1 to 6 HCV.The potential benefits of SOF/VEL/GS-9857 for the treatment of HCV include increased effectiveness, shorter treatment duration (8 weeks) and a once-daily, single tablet, pangenotypic (effective across a broad range of genotypes) therapy for HCV infection, which could simplify treatment, reduce medical resource utilisation and impact worldwide disease prevalence.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0191
Date of REC Opinion
22 Jan 2016
REC opinion
Further Information Favourable Opinion