A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection [Protocol: GS-US-248-0122]

Trial ID:
IRB-11-5847
Paul Pockros
This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

Inclusion Criteria:

  • Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent (OAV)
  • Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
  • Provide written, informed consent
  • Be willing and able to comply with the visit schedule and protocol-mandated procedures.

Exclusion Criteria:

  • Subject plans to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry.
  • History of clinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol.