ReferenceRRK4547

GS-US-248-0123

A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

Research Summary

Rationale for the Registry StudyGilead Sciences is developing a number of novel antiviral agents targeting variouscomponents of the hepatitis C virus lifecycle. Since it is apparent that combination therapyapproaches will be required to achieve sustained virologic responses Gilead is conducting a number of clinical studies evaluating the safety tolerability and antiviral efficacy of various combination regimens in patients with chronic HCV infection. Each of the oral antiviral agents (OAVs) utilized in these regimens may be associated with the selection of signature mutations which if unchecked may result in virologic breakthrough and treatment failure.Combination strategy approaches are thus not only directed toward additive or synergisticviral load reductions but importantly the cross coverage of emerging mutant variants.This Registry will provide long-term follow-up to evaluate HCV viral sequences and thepersistence or evolution of viral mutations in subjects who did not achieve an SVR in aprevious Gilead-sponsored hepatitis C trial following receipt of study medication containing at least one OAV.

Research Overview
PI Name Mutimer - DJ
Speciality
Sponsor Gilead Sciences
Project Status Open
Proposed End Date 31/01/2017
Study Run through CRF? Yes
Target number of patients agreed to recruit 1
Recruitment so far 0