Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)

Study Overview
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Brief Summary
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The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.

Official Title
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Long Term Follow-up for Subjects With Chronic Hepatitis C Infection Who Received Interferon-based Therapy or Direct-acting Antiviral Agents (DAAs)-Based Therapy

Conditions
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Chronic Hepatitis C Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic hepatitis C treated with interferon-based therapy or direct-acting agents (DAAs)-based regimen; Provide written, informed consent; Be willing and able to comply with the visit schedule and protocol-mandated procedures. 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 time frame; History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol. Inability to provide written informed consent.

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 |
| --- | --- | --- |
| Sustained virological response (SVR) | The primary outcome measure is the occurence (yes or no) of sustained virologic response (SVR), defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various patients receiving IFN or DAAs based treatment. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment persistence | Treatment persistence will be the duration of treatment measured from the first dose of medication until treatment is discontinued. Reasons for premature discontinuation of treatment will be recorded. | 36 months | 
| Virological breakthrough | The occurrence of virological breakthrough defined as an increase of HCV RNA by at least 1-log over nadir or to >100 IU if previously undetectable. | 36 months | 
| 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. | Post treatment 10 years | 
| Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen |  | Post treatment 5 years |