Oral Sofosbuvir/GS-5885 ± Ribavirin in HCV patients

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 HCV Infection

• IRAS ID

  115994

• Contact name

  Graham Foster

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2012-003387-43

• Clinicaltrials.gov Identifier

  NCT01701401

• Research summary

  A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed Dose Combination with or without Ribavirin for 12 and 24 Weeks in Treatment-NaÇîve Subjects with Chronic Genotype 1 HCV Infection. Hepatitis C Virus (HCV) infection is a global health challenge with an estimated 180 million individuals infected worldwide. The total HCV-infected population in the United Kingdom is estimated to be around 250,000 people. Hepatitis C is a disease caused by a virus (also called HCV) that infects the liver. When the Hepatitis C virus invades healthy liver cells, it causes those cells to become inflamed. Over time, this may cause scarring (fibrosis) of the liver or permanent liver damage (cirrhosis), which will affect the way that the liver functions. In addition, people infected with chronic HCV may develop liver cancer and/or need a liver transplant. The purpose of the study is to help determine if a new fixed-dose combination (FDC) pill that combines two new experimental drugs (sofosbuvir and GS-5885) into one pill; sofosbuvir/GS-5885 FDC given alone or given in combination with ribavirin for 12 weeks or 24 weeks is safe and able to clear HCV from the body. The study will be carried out across 100 sites in Europe and the United States with approximately 800 patients that will be invited to participate. Eligible patients will be randomly assigned to receive Sofosbuvir/GS-5885 Fixed Dose Combination with or without Ribavirin. The study will consist of screening, a treatment phase and a follow up phase until the patient's condition worsens or they decide to withdraw from the study. Participation could last up to 1 year and 2 weeks.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  12/LO/1748

• Date of REC Opinion

  18 Dec 2012

• REC opinion

  Further Information Favourable Opinion