Gilead Sustained Virologic Response (SVR) Registry

Study Overview
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Brief Summary
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This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

Official Title
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A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

Conditions
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Hepatitis C, Chronic

Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent (OAV) Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol Provide written, informed consent Be willing and able to comply with the visit schedule and protocol-mandated procedures 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants maintaining SVR at Week 144 by treatment regimen |  | Week 144 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen |  | Up to 144 weeks | 
| Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen |  | Up to 144 weeks | 
| Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen |  | Up to 144 weeks | 
| 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. | Up to 144 weeks | 
| Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen |  | Up to 144 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Registry, HCV RNA, Treatment experienced, Treatment naive, GS 9451, GS 5885, GS 7977, GS 5816, Sofosbuvir, Sovaldi™, SOF, Ledipasvir, LDV