A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
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This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.
Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen [ Time Frame: Up to 3 years ]
Secondary Outcome Measures
Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen [ Time Frame: Up to 3 years ]
Average number of DRM loss by treatment regimen [ Time Frame: Up to 3 years ]
Liver disease progression [ Time Frame: Up to 3 years ]
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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead OAV 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 OAV
Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol
Provide written, informed consent
Be willing and able to comply with the visit schedule
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.