This Registry will enroll cirrhotic participants with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.
A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
Hepatitis C Virus InfectionHCV Cirrhosis registryCirrhosisHepatitis CInterferonsSofosbuvir
For people ages 18 years and up
Key Inclusion Criteria:
Willing and able to provide written informed consent
Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.
Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment.
Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.
Key Exclusion Criteria:
Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
University of California at San Francisco Medical Center San Francisco, California, United States
Quest Clinical Research San Francisco, California, United States
Stanford University Stanford, California, United States
University of California, Davis Medical Center Sacramento, California, United States
Huntington Medical Research Institute Pasadena, California, United States
Cedars-Sinai Medical Center for Liver Diseases and Transplantation Los Angeles, California, United States
Kaiser Permanente Medical Center Los Angeles, California, United States
Ruane Clinical Research Group, Inc. Los Angeles, California, United States
V.A. Medical Center Long Beach, California, United States