Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Study Overview
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Brief Summary
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The objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.

Detailed Description
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In addition, the mechanism of non-responsiveness of HCV patients to IFNa will be studied. For this purpose, formation of complexes between STAT1 and its negative regulator, PIAS1 (immunoprecipitation, Western blot) will be examined. In comparing subjects on standard therapy vs the addition of betaine, (under separate studies) we will assess whether the formation of STAT1-PIAS1 complexes is due to impaired methylation on STAT1 on arginine residues which may be over come by the addition of betaine.

Official Title
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Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Procedure: Blood sampling of peripheral blood mononuclear cells
* Procedure: Blood draw, 20ml peripheral blood mononuclear cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 19 years of age or older, of either gender History of chronic hepatitis C documented by HCVRNA or healthy family member/significant other Documented genotype 1 for hepatitis participants or no hepatitis infection for healthy control Subject prescribed antiviral therapy for hepatitis participants or none for healthy control Able to give informed consent Exclusion Criteria Under 19 years of age Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>20 patients with genotype 1, chronic hepatitis C who are to undergo standard antiviral therapy | Procedure: Blood sampling of peripheral blood mononuclear cells<br>* Group 1, (Patients): PMBC (20 ml blood) to be drawn at baseline, weeks 4 and 12 during antiviral therapy and 24 weeks following the end of antiviral therapy<br>|
| control<br>Group 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy | Procedure: Blood draw, 20ml peripheral blood mononuclear cells<br>* One time blood draw of 20 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment | To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells | To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, Genotype 1