Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India

Study Overview
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Brief Summary
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This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment decisions and outcome

Detailed Description
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The overall goal of this study is to correlate the host and viral genetics of patients infected with viral hepatitis with their clinical presentation. This study will provide the first nation-wide estimate of key host genetic polymorphisms associated with immune response, such as in the IL28B gene locus which has been associated with treatment outcomes in hepatitis C. Characterization of HCV and HBV viral genotypes and sub-types across different geographic regions will allow for an exploration of associations between host and viral genotypes. Another objective of this study is to identify co-morbid illness and metabolic factors that are associated with chronic liver disease due to viral hepatitis. Finally, this survey will explore patient awareness of their disease, risk factors for disease progression, and their treatment options

Official Title
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Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India

Conditions
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Hepatitis B, Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent Male or female, age >= 18 Willing and able to comply with the visit procedure Prior diagnosis of chronic HCV infection or chronic HBV infection Exclusion Criteria: History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy History of bleeding disorder Blood loss requiring transfusion or > 3 g/dL decrease in hemoglobin within 4 days of the visit Knowingly co-infected with HCV/HBV or with HIV Currently undergoing therapy for chronic hepatitis C or chronic hepatitis B Currently receiving treatment with any other investigational agent or device -- Enrolled in another clinical study evaluating a treatment or procedure

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV Cohort<br>A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HCV infection | |
| HBV Cohort<br>A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HBV infection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in the IL28B rs12979860 SNP | Characterize the variation in the IL28B rs12979860 SNP that exists among patients with chronic hepatitis C or chronic hepatitis B infection, in the different geographic regions of India | One Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevelance of HBV and HCV genotypes | Assess the prevalence of HBV and HCV genotypes and subtypes in different geographic regions of India | One Visit | 
| Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7) | Characterize the SNPs present in innate immune factors TLR7 (rs3853839, rs179008); TLR9 (rs41308230, rs5743844 ); RIG-I (rs11795404, rs10813831) and NOD2 (rs2067085, rs2066842), in patients with chronic hepatitis C or chronic hepatitis B in the different geographic regions of India | One Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV, HCV, chronic, India, observational study, prevalence,, genotypes, SNPs, viral hepatitis