A long-term study to follow cirrhotic patients infected with chronicHepatitis C who achieved a cure following treatment in a Gilead clinicaltrial.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1600

Inclusion Criteria

1) Willing and able to provide written informed consent;
2) Have 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 subjects must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12
3) Have achieved SVR in a Gilead-sponsored study, as defined in the treatment protocol; OR for subjects 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.
4) Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen;OR Subjects who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis as diagnosed prior to initiation of HCV treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1296
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 311

Exclusion Criteria

1) Subject plans to initiate a new course of HCV therapy, including
approved products and any investigational agents, during the course of this Registry;
2) History of clinically-significant illness or any other major medical
disorder that may interfere
with the subject follow-up, assessments or compliance with the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the durability of SVR;<br>To assess clinical progression or regression of liver disease, including<br>the incidence of<br>hepatocellular carcinoma (HCC) following SVR.;Secondary Objective: To determine whether subsequent detection of HCV RNA in subjects who<br>relapse following<br>SVR represents the re-emergence of pre-existing virus, the development<br>of resistance<br>mutations, or re-infection.<br>To assess quality of life following SVR.;Primary end point(s): None. This is an observational study.;Timepoint(s) of evaluation of this end point: n/a

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None. This is an observational study.;Timepoint(s) of evaluation of this end point: n/a

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