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.
Study Type
OBSERVATIONAL
Enrollment
570
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
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
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.
Time frame: Up to 3 years
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen
Time frame: Up to 144 weeks
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Birmingham Gastroenterology Associates
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Digestive Health Specialists
Dothan, Alabama, United States
Mayo Clinic
Phoenix, Arizona, United States
University of Arizona
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
Davis, California, United States
...and 313 more locations