A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen	Up to 3 years
Average number of DRM loss by treatment regimen	Up to 3 years
Liver disease progression	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	Up to 144 weeks

Locations (310): Birmingham Gastroenterology Associates
🇺🇸
Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Digestive Health Specialists
🇺🇸
Tupelo, Mississippi, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
University of Arizona
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Tucson, Arizona, United States
Advanced Clinical Research Institute, LLC
🇺🇸
Anaheim, California, United States
Franco Felizarta, MD
🇺🇸
Bakersfield, California, United States
Southern California Medical Group
🇺🇸
Coronado, California, United States
West Coast Clinical Trials, LLC
🇺🇸
Costa Mesa, California, United States
UC Davis Medical Center
🇺🇸
Sacramento, California, United States
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Birmingham Gastroenterology Associates
🇺🇸Birmingham, Alabama, United States