Open Label Efficacy and Safety of SOF/GS-5816 FDC for 12 weeks in HCV
Research type
Research Study
Full title
An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection
IRAS ID
158454
Contact name
Graham Foster
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-003898-42
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Hepatitis C (HCV) is an infectious disease that mainly affects the liver, causing liver scarring which may lead to liver failure or liver cancer. There are 6 major types of HCV called Genotypes 1-6. There is no current standard treatment for all genotypes of HCV. Globally, not all patients are able to have their genotype tested, 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 aid 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, largely depression and anaemia. In patients with advanced disease, interferon based treatment is very poorly tolerated (and may lead to lethal side effects) and is 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 liver scarring and those who 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 unapproved combination of sofosbuvir plus ledipasvir (an NS5A inhibitor – a drug that stops the viral protein 5A), is well tolerated with cure rates approaching 99% for genotypes 1 & 4. GS-5816 (an NS5A inhibitor) has shown activity across all HCV genotypes. The fixed dose combination tablet, proposed in this study, represents a simple, well tolerated, effective treatment for all HCV infected patients of all genotypes over only 12 weeks.
This study is an open-label study of sofosbuvir / GS-5816 fixed dose combination tablet in participants who received placebo in study GS-US-342-1138.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1262
Date of REC Opinion
24 Dec 2014
REC opinion
Favourable Opinion