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

Study ID
STU 102012-074

Cancer Related

Healthy Volunteers

Study Sites

Tianna Petersen

Principal Investigator
Mamta Jain


This Registry will enroll subjects who did not achieve an SVR after receiving at least one oaV while participating in a Gilead-sponsored hepatitis C clinical trial. The definition of an SVR is defined in the initial Gilead-sponsored treatment protocol.

once enrolled, subjects will be followed for up to 3 years. a Baseline visit will be scheduled within 90 days from the last visit in the Gilead-sponsored treatment protocol. Subsequent visits will occur at Weeks 24, 48, 72, 96, 120 and 144. at each visit, subjects will have a blood sample collected for HCV Rna, viral sequencing, liver function tests, platelets, coagulation test and [RegisteredTM]-fetoprotein. in addition, a quality of life survey will be completed at each visit.

Participant Eligibility

1. Willing and able to provide written informed consent;

2. Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV;

3. Have failed to achieve an SVR in that previous Gilead-sponsored study, as defined in the original treatment protocol;

4. Be willing and able to comply with the visit schedule and protocol-mandated procedures.