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 (Protocol #: GS-US-248-0123: 13 April 2011)

Study ID
STU 102011-095

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other

Contact
Theresa Hardwick
214-645-6195
theresa.hardwick@utsouthwestern.edu

Principal Investigator
William Lee

Summary

This Registry will enroll subjects who failed to achieve an SVR after receiving at least one Gilead oral antiviral agent (oaV) while participating in a Gilead-sponsored hepatitis C clinical trial. The definition of failure to achieve an SVR is defined in the Gilead-sponsored treatment protocol, however, this Registry aims to include subjects whose HCV Rna:
* Failed to drop below the Lower Limit of Quantification (LLoQ) on treatment;
* Dropped below the LLoQ and then had a confirmed value above the LLoQ during treatment (breakthrough);
* Dropped below the LLoQ and then had a confirmed value above the LLoQ during the post-treatment follow-up period (relapse).

once enrolled, subjects will be followed for up to 3 years. Clinic visits will occur at Baseline and at Weeks 12, 24, 36, 48, 96 and 144. at each visit, subjects will have blood drawn for plasma HCV Rna quantification, viral sequencing, liver function tests, platelets, coagulation test and
[RegisteredTM]-fetoprotein. Viral sequences to be evaluated will be based on the specific antiviral agent(s) that the subject was treated with during the initial Gilead-sponsored treatment protocol. Subjects who have no drug resistant mutations (DRMs) by a sensitive sequencing method at any time during the Registry and subjects who begin a new treatment course for HCV infection will discontinue participation in the Registry.

This study is open to any subject who has failed to achieved an SVR after receiving at least one Gilead oaV while participating in a Gilead sponsored hepatitis C study. The total number of people participating in this research study at over 100 centers in the united States and world-wide is unknown. about 30 patients who failed to attain failed to achieve an SVR will be screened in this study at uT Southwestern Medical Center.

Participant Eligibility

Subjects must meet all of the following inclusion criteria to be eligible for participation in this Registry.
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.