Gilead Sustained Virologic Response (SVR) Registry

Gilead Sciences6,625 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

6,625

Conditions

Hepatitis C, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (325)

Outcomes

Primary Outcomes

Proportion of participants maintaining SVR at Week 144 by treatment regimen

Time frame: Week 144

Secondary Outcomes

Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen

Time frame: Up to 144 weeks

Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen

Time frame: Up to 144 weeks

Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen

Time frame: 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.

Time frame: Up to 144 weeks

Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen

Time frame: Up to 144 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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