POLARIS Retreatment
Research type
Research Study
Full title
An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects who Participated in a Prior Gilead-Sponsored HCV Treatment Study
IRAS ID
226428
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2017-000179-98
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND, 125751
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Hepatitis C virus (HCV) infection is a global health challenge with 150 million estimated individuals infected worldwide. HCV primarily affects the liver and can cause cirrhosis (permanent liver damage) leading onto liver failure or cancer.
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.
This study aims to enrol approximately 50 participants who participated in a prior Gilead-sponsored HCV treatment study of direct acting antivirals (DAA)-containing regimen. The study will take place at approximately 36 centres in the UK, US, Canada, New Zealand, Australia, France and Germany.
This study will provide information on the safety and efficacy of SOF/VEL/VOX fixed dose combination (FDC) in participants with chronic HCV infection of all genotypes.
SOF/VEL/VOX FDC is a combined formulation in a single tablet that combines three mechanisms of action:
- Sofosbuvir (SOF), as 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 approved in the US and other regions for the treatment of HCV infection in combination with SOF.
- Voxilaprevir, an HCV NS3/4A protease inhibitor that has in vitro antiviral activity against genotypes 1 to 6 HCV.The potential benefits of SOF/VEL/VOX FOC are addressing the unmet medical need of the growing population of patients who have failed prior therapies with DAA regimens in a once-daily, single tablet, pangenotypic (effective across a broad range of genotypes) therapy.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0159
Date of REC Opinion
16 Jun 2017
REC opinion
Further Information Favourable Opinion