Sofosbuvir/GS-5816 v. Sofosbuvir and Ribavirin in HCV

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 24 Weeks in Subjects with Chronic Genotype 3 HCV Infection

• IRAS ID

  158453

• Contact name

  Graham Foster

• Contact email

  g.r.foster@qmul.ac.uk

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2014-001682-27

• 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 7 major types of HCV called Genotypes 1-7. In the UK, 80,000 people have Genotype 3 (G3). It is believed that G3 infection may have higher rates of death and development of liver cancer than in patients with other HCV genotypes. Standard of care for G3 treatment is currently 24 weeks of interferon injections (a protein that forms part of the immune system) with ribavirin (which stops viral growth). Patients respond to this therapy but the side effects are significant. The therapy is poorly tolerated in patients with advanced disease (fewer than 50% of G3 patients respond) and may lead to lethal side effects. Sofosbuvir (SOF) alone for 24 weeks cures a proportion of patients with G3 but this is an
  expensive option that is relatively ineffective in some patients, particularly those with scarring and those who have failed to respond to the standard of care therapy.

  All tablet combination of SOF and Ledipasvir (an NS5A inhibitor - a drug that stops the viral protein 5A) is well tolerated and effective with cure rates approaching 99% for other genotypes but Ledipasvir is not effective against G3. G5816 is an NS5A inhibitor that has shown effectiveness in laboratory tests across all genotypes. Previous studies have shown that the combination of SOF and GS-5816 for 12 weeks is well tolerated and effective across all genotypes.

  This study compares treatment with SOF and GS-5816 for 12 weeks with SOD and Ribavirin for 24 weeks. It addresses the question of whether a single tablet of SOF plus GS-5816 will successfully treat patients with G3 using a well-tolerated, all oral, effective therapy.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  14/YH/1057

• Date of REC Opinion

  30 Jul 2014

• REC opinion

  Further Information Favourable Opinion