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

Humanity and Health Research Centre1,210 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,210

Conditions

Chronic Hepatitis C Infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

Beijing, Beijing Municipality, China

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, China

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, Japan

Outcomes

Primary Outcomes

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.

Time frame: 36 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Post treatment 10 years

Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen

Time frame: Post treatment 5 years

Data from ClinicalTrials.gov

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