A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participants with cirrhosis who have achieved an SVR after receiving a SOF-based regimen without IFN while participating in a Gilead-sponsored HCV study. In addition, participants with cirrhosis who have achieved SVR after an all-oral SOF-based regimen outside a clinical study may be eligible to enroll in this registry at sites preselected by Gilead.
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.