Thailand HDV Cohort

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

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

Study Overview

• Status: Recruiting
• Conditions: HDV

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 3152

Contacts and Locations

• Study Contact: Name: Chatsuda Auchieng; Phone Number: 118 6626523040; Email: chatsuda.a@hivnat.org
• Study Contact Backup: Name: Pirapon J Ohata, BSc; Phone Number: 147 6626523040; Email: juneohata4@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • HIV-NAT, Thai Red Cross - AIDS Research Centre
    • Contact: Chatsuda Auchieng; Phone Number: 118 6626523040; Email: chatsuda.a@hivnat.org
    • Contact: Anchalee Avihingsanon, MD, PhD; Phone Number: 107 6626523040; Email: anchaleea2009@gmail.com
  • Bangkok, Thailand, 10330
    • Recruiting
    • King memorial Chulalongkorn hospital
    • Contact: Pisit Tangkijvanich, MD; Email: pisittkvn@gmail.com
  • Bangkok, Thailand
    • Recruiting
    • Siriraj Hospital, Mahidol University
    • Contact: Tawesak Tanwandee, MD
  • Bangkok, Thailand
    • Recruiting
    • Taksin Hospital
    • Contact: Supunee Jirajariyavej, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Male or female, aged 18 years and older

2. 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

3. Provide signed and dated informed consent form.

Exclusion Criteria:

Non chronic HBV

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HDV cohort; 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?

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

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Gilead Sciences; Thai Red Cross AIDS Research Centre; King Chulalongkorn Memorial Hospital; Taksin Hospital; Siriraj Hospital
• Investigators: Principal Investigator: Pisit Tangkijvanich, MD, Biochemistry, Faculty of Medicine, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: cirrhosis; HBV; Thailand; HDV
• Other Study ID Numbers: HIV-NAT 304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No