Thailand HDV Cohort

Study Overview
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Brief Summary
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There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. Therefore, this study plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. Findinds from this study will provide the scientific community to understand how important HDV is among HBV patients, this could be used to develop strategies for HDV screening and treatment

Detailed Description
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The prevalence of HDV remains ill-defined, mainly for lack of appropriate testing and screening. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. This data will inform the guideline whether HDV screening among HBV/HIV is required. This study has plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. This Nationwide survey of HDV is collaboration between Thai liver society, Thai AIDS society, Thai Red Cross AIDS research centre, Faculty of Medicine Chulalongkorn University, and AIDS TB and STI Control Division, Department of Disease control, MOPH Thailand. All findings will be shared and discussed to develop the National guideline for screening, treatment and care.

Official Title
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Prevalence, Risk Factor and Clinical Significance of Hepatitis D Virus Infection Among Targeted High Risk Population in Thailand: Nationwide Survey 2022-2024

Conditions
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HDV

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 years and older Chronically-infected with HBV, as defined by: Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result Provide signed and dated informed consent form. Exclusion Criteria: Non chronic HBV

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 |
| --- | --- |
| HDV cohort<br>Chronic Hepatitis B (HBsAg+) with cirrhosis (APRI >1.5, FIB-4 > 3.25, Fibroscan > 12.5, imaging), PWID with HBV, HIV/HBV, HBV/HCV, aged 18 years and older | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of HDV | prevalence of HDV in patients with cirrhosis | 1 year | 
| prevalence of HDV | prevalence of HDV in patients with non cirrhosis | 1 year | 
| prevalence of HDV | prevalence of HDV in HIV positive people with injecting drug use | 1 year | 
| prevalence of HDV | prevalence of HDV in HIV negative people with injecting drug use | 1 year | 
| prevalence of HDV | prevalence of HDV among HBV/HIV men who have sex with men | 1 year | 
| prevalence of HDV | prevalence of HDV among HBV/HIV cisgender male patients | 1 year | 
| prevalence of HDV | prevalence of HDV among prisoners | 1 year | 
| proportion of participants with detectable HDV RNA among seropositive anti HDV | proportion of participants with detectable HDV RNA among seropositive anti HDV with cirrhosis | 1 year | 
| proportion of participants with detectable HDV RNA among seropositive anti HDV | proportion of participants with detectable HDV RNA among seropositive anti HDV without cirrhosis | 1 year | 
| proportion of participants with detectable HDV RNA among seropositive anti HDV | proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID with HIV | 1 year | 
| proportion of participants with detectable HDV RNA among seropositive anti HDV | proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID without HIV | 1 year | 
| proportion of participants with detectable HDV RNA among seropositive anti HDV | proportion of participants with detectable HDV RNA among seropositive anti HDV with HIV/HBV MSM | 1 year | 
| proportion of participants with detectable HDV RNA among seropositive anti HDV | proportion of participants with detectable HDV RNA among seropositive anti HDV in HIV/HBV cisgender males | 1 year | 
| proportion of participants with detectable HDV RNA among seropositive anti HDV | proportion of participants with detectable HDV RNA among seropositive anti HDV in prisoners | 1 year | 
| predictive risk of HDV infection | predictive risk of HDV infection | 1 year | 
| HDV subtype | HDV subtype among people with cirrhosis | 1 year | 
| HDV subtype | HDV subtype among people without cirrhosis | 1 year | 
| HDV subtype | HDV subtype in PWID with HIV | 1 year | 
| HDV subtype | HDV subtype in PWID without HIV | 1 year | 
| HDV subtype | HDV subtype in HBV/HIV MSM | 1 year | 
| HDV subtype | HDV subtype in HBV/HIV cisgender males | 1 year | 
| HDV subtype | HDV subtype in prisoners | 1 year | 
| performance of antiHDV commercial kits | performance of antiHDV commercial kits | 1 year | 
| prevalence of HDV among HBV/HIV before combination antiretroviral therapy | prevalence of HDV among HBV/HIV before combination antiretroviral therapy | 1 year | 
| prevalence of HDV among HBV/HIV after combination antiretroviral therapy | prevalence of HDV among HBV/HIV after combination antiretroviral therapy | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV, HDV, cirrhosis, Thailand