The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
This Registry is designed to provide long term clinical and virologic follow up in participants 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.
Proportion of participants maintaining SVR at Week 144 by treatment regimen [ Time Frame: Week 144 ]
Secondary Outcome Measures :
Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
Liver disease progression [ Time Frame: Up to 144 weeks ]
Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored HCV study.
Key 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
Key Exclusion Criteria:
Individuals planning 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 follow up, assessments, or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.