GS-0148: GS-5885 alone or with GS-9451 with PEG/RBV for Hepatitis C

• Research type

  Research Study

• Full title

  A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS 5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection

• IRAS ID

  82128

• Contact name

  Graham Foster

• Sponsor organisation

  Gilead Sciences Inc

• Eudract number

  2011-000456-42

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Hepatitis C virus (HCV) affects an estimated 180 million patients worldwide. Up to 85% of patients fail to clear the virus and progress to chronic infection. Consequences of this include chronic liver disease with progression to cirrhosis (scarring of the liver) and liver cancer. The treatment goal for chronic HCV is removal of the virus. Current treatment consists of once-weekly pegylated interferon (PEG) injections and twice-daily ribavirin (RBV) tablets. However, the most common type of HCV is the least likely to respond, with 40-50% of patients unable to achieve lasting virus clearance after 48 weeks. Additionally, current treatment is poorly tolerated with 20-30% of patients stopping due to side effects. GS-5885 and GS-9451 are being developed as inhibitors of HCV. The purpose of this study is to assess the efficacy, safety and tolerability of GS-5885 alone or in combination with GS-9451 for the treatment of HCV.Eligible participants will be randomised to one of two treatment arms:Arm 1: GS-5885 GS-9451 PEG/RBVArm 2: GS-5885 PEG/RBVThey will have a 67% chance of being assigned to Arm 1 and a 33% chance of being assigned to Arm 2. They may continue PEG and RBV throughout the study depending on HCV viral load.Participants will receive treatment for 12, 24 or 48 weeks depending on the treatment arm and response to study drugs. Those in Arm 1 could be treated for up to 72 weeks. Participants will initially attend study visits every 2 weeks and then every 4 weeks. Study procedures include vital signs, ECG, physical examination, and blood and urine samples for laboratory testing.This study is sponsored by Gilead Sciences, Inc. Approximately 300 patients will participate in this study in the US, Europe, Australia and New Zealand, with 27 patients from 4 hospitals in the UK.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/0990

• Date of REC Opinion

  11 Aug 2011

• REC opinion

  Further Information Favourable Opinion