SR-BI and Antiviral Treatment Response in HCV

Study Overview
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Brief Summary
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The scavenger receptor type B class I (SR-BI) is a receptor for high-density lipoproteins (HDL) and one of entry factors for hepatitis C virus (HCV). The investigators aimed to examine the association of single nucleotide polymorphisms (SNPs) of the SCARB1 gene, which encodes SR-BI, with virologic responses to pegylated interferon-based treatment in Asian chronic hepatitis C (CHC) patients.

Detailed Description
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Purpose of study: To examine the impacts of single nucleotide polymorphisms (SNPs) relevant to SR-BI on CHC patients. Study Design To enroll 400 CHC patients during a 3-year period Specify objectives of study when collecting extra specimen from participants Collect blood samples for genomic DNA to examine the SR-BI gene polymorphisms. Expected Endpoints of Treatment Sustained virologic response (SVR) means undetectable serum HCV RNA levels 24 weeks after completion of antiviral therapy.

Official Title
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Influence of Scavenger Receptor Class B Type I (SR-BI) Gene Polymorphisms on Antiviral Treatment Response, and Metabolism in Chronic Hepatitis C Patients

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Naive to IFN treatment and other experimental antiviral or immunosuppressive therapy before enrollment. Serum alanine aminotransferase levels, at least, twice the upper limit of normal on two occasions within the previous 6 months. Exclusion Criteria: Positive for hepatitis B surface antigen Positive for human immunodeficiency virus antibody Had a known history or evidence of autoimmune liver disease, inheritable disorders, renal insufficiency, malignancy Had a history of daily alcohol consumption greater than 20 gram or active drug abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV group (Peginterferon alfa-2a)<br>A total of 156 chronic HCV genotype 1 or 2 patients who received Peginterferon alfa-2a (Peg-IFN alfa-2a) plus ribavirin therapy were consecutively enrolled from the gastroenterological clinics. | Drug: Peginterferon alfa-2a<br>* Peginterferon alfa-2a 180μg plus daily oral weight-based ribavirin (1,000 mg for body weight 75 kg or less, 1,200 mg for body weight greater than 75 kg) for 24 or 48 weeks<br>* Other names: Pegsys;|
| Control Group<br>There were 153 healthy controls negative for anti-HCV enrolled simultaneously from the database of Health Management Center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum HCV RNA levels | sustained virologic response | at 24 weeks after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum fasting blood glucose levels |  | at 24 weeks after the end of treatment |