Polaris 4

• 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 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects with Chronic HCV Infection who Have Not Received an NS5A Inhibitor

• IRAS ID

  193776

• Contact name

  Graham Foster

• Contact email

  g.r.foster@qmul.ac.uk

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2015-003167-10

• 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.

  There are 7 major genotypes (genetic variations) of HCV; there is no current standard of care treatment for all genotypes. 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 380 participants aged over 18 with chronic HCV who have previously been treated with DAA medications but not with an NS5A inhibitor medication. The study will take place at approximately 120 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/GS- 9857 fixed dose combination (FDC) and SOF/VEL in participants with chronic HCV infection of all genotypes.

  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 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

  East of Scotland Research Ethics Service REC 2

• REC reference

  15/ES/0192

• Date of REC Opinion

  20 Jan 2016

• REC opinion

  Further Information Favourable Opinion