Safety and Efficacy of GS-9451 with/out Tegobuvir in Patients with HCV

• Research type

  Research Study

• Full title

  A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of a Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection (Protocol GS-US-196-0140)

• IRAS ID

  72089

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2010-023952-10

• Clinicaltrials.gov Identifier

  NCT01271790

• Research summary

  A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate 3 Different Treatment combinations Followed by Response Guided PEG and RBV in Treatment NaÇîve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection -----------------------------------------------------------------------------Hepatitis C (HCV) is a blood-borne virus that predominantly infects the cells of the liver. Chronic hepatitis C is defined as infection persisting for more than six months. In the UK over 400,000 people are thought to be infected with hepatitis C.The currently available standard treatment of HCV genotype 1 infection is a combination of peginterferon (PEG) and ribavirin (RBV). This treatment can clear the virus ('cure') in over half of all cases. Tegobuvir and GS-9451 are investigational medications being tested in this protocol.Eligible participants will be randomly assigned into one of three treatment arms: 1) 16 or 24 weeks (depending on response) of 4-medication treatment: tegobuvir and GS-9451, with combination of PEG/RBV2) 24 weeks of 3-medication treatment: Placebo and GS-9451, with combination of PEG/RBV3) 48 weeks of standard care of 2-medication treatment: Placebo with combination of PEG/RBVAfter treatment, all the participants will be followed-up to 72 weeks.The randomisation is in a 2:1:1 ratio, so participants have a 50% chance to be assigned to Arm 1 and 25% chance to be assigned to either Arm 2 or 3.The use of combinations of anti-HCV medications with different mechanisms of action, such as tegobuvir (polymerase inhibitor) and GS-9451 (protease inhibitor) with combination of PEG/RBV may result in more rapid and sustained viral suppression.The purpose of this study to evaluate safety and efficacy of the treatment combinations outlined above, followed by response guided PEG/RBV in chronically infected naive (previously not treated) patients with HCV genotype 1 infection. Approximately 320 patients will be invited to participate in this study at up to 180 centers in North America and Europe.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/0293

• Date of REC Opinion

  6 Jun 2011

• REC opinion

  Further Information Favourable Opinion