GS-9190 and GS-9256 for the treatment of Hepatitis C virus infection

• Research type

  Research Study

• Full title

  A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy with GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a(Pegasys®)in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection

• IRAS ID

  63772

• Contact name

  Graham Foster

• Sponsor organisation

  Gilead Sciences International Ltd.

• Eudract number

  2010-020911-35

• ISRCTN Number

  N/A

• Research summary

  The hepatitis C virus is spread by blood-to-blood contact. Most people have few, if any symptoms after the initial infection, yet the virus persists in the liver in about 85% of those infected. Persistent infection can be treated with medication, peginterferon (PEG) and ribavirin (RBV) being the standard-of-care therapy. Although this is difficult to tolerate resulting in dose reductions and early treatment discontinuations leading to reduced efficacy. Considering than an estimated 180 million patients worldwide are chronically infected, the impact of HCV on morbidity, mortality and associated health-care costs is tremendous. The purpose of this study is to compare the effectiveness, safety and tolerability of up to 24 weeks treatment with the experimental drugs GS-9190 and GS-9256 when given with PEG and RIBA, for the treatment of chronic HCV infection. Approx. 320 male and female patients between 18 and 70 years of age with chronic genotype 1 Hepatitis C infection who have acceptable clinical lab test results and meet all of the other entry criteria will be enrolled in the study, which will be run in up to 135 sites in Europe and North America. Approx. 80 of these patients will also enter a Pharmacokinetic/viral dynamic sub study which will measure how the body affect the drug and levels of hepatitis C virus. Patients who consent will also give a blood sample for genetic discovery research in a pharmacogenomic sub study (the fluence of genetic variation on drug response in patients) to identify or validate genetic markers that may be predictive of the natural history of HCV disease, the virologic response to therapy, and the tolerability of drugs used in HCV therapeutics

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/66

• Date of REC Opinion

  22 Nov 2010

• REC opinion

  Further Information Favourable Opinion