Efficacy and Safety of SOF/GS-5816 FDC for 12 weeks in Chronic HCV
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects with Chronic HCV
IRAS ID
157957
Contact name
Graham Foster
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-001683-35
Research summary
Hepatitis C is an infectious disease, caused by the hepatitis C virus (HCV) that primarily affects the liver. Chronic infection causes liver cirrhosis which leads onto liver failure or liver cancer. Liver transplant is then required. There are 7 major genotypes of HCV. There is no current standard of care treatment for all genotypes of HCV. Globally, not all patients are able to undergo genotyping, so therapies are not aligned to their specific HCV genotype and consequently, not as effective as they need to be. A therapy that avoids the costs and delays of having to assess the HCV genotype would facilitate therapy and reduce treatment cost. Although many patients respond to 24 weeks therapy with interferon injections and ribavirin this therapy is associated with very significant side effects, chiefly depression and anaemia. In patients with advanced disease/ cirrhosis, interferon based therapies are very poorly tolerated (and may lead to lethal side effects) and are relatively ineffective. Sofosbuvir for 24 weeks cures a proportion of patients with HCV but this is an expensive option that is relatively ineffective in some subgroups of patients, particularly those with cirrhosis and those who have failed to respond to pegylated interferon and ribavirin. All oral combination therapy for HCV has recently been introduced for patients with genotypes 1, 2, 4, 5 and 6 and the combination of sofosbuvir plus an NS5A inhibitor (ledipasvir), has shown excellent tolerability and efficacy with cure rates approaching 99%. GS-5816 is an NS5A inhibitor that has shown activity across all HCV genotypes. The fixed dose combination tablet, proposed in this study, may represent a simple, well tolerated, effective pangenotypic treatment for all HCV infected patients.
This study addresses the question of whether sofosbuvir plus GS-5816 will allow patients across HCV genotypes to be treated successfully with all oral therapy.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1056
Date of REC Opinion
29 Jul 2014
REC opinion
Further Information Favourable Opinion