HDV Screening Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatitis D Virus Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Universal Screening for Hepatitis Delta Virus (HDV) in Individuals Living with HIV/HBV Coinfection and HBV-related HCC
Overview
This is a territory-wide cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC.
Detailed description
Chronic hepatitis B virus (HBV) infection remains endemic in Hong Kong with an estimated prevalence of 6.2% in the recent Population Health Survey 2020-2022.1 The estimated prevalence of chronic HBV infection among individuals living with HIV is 8%.2 Yet, no data are available concerning the disease burden of hepatitis delta virus (HDV) among individuals living with HIV/HBV coinfection.
Primary outcome measures
- Rate of positive anti-HDV [Time frame: at screening]
Secondary outcome measures (2)
- Prevalence rate of detectable HDV RNA [Time frame: at screening]
- Prevalence rate of compensated advanced chronic liver disease [Time frame: at screening]
Eligibility criteria
Inclusion criteria
- Individuals with HIV infection, i.e. anti-HIV or HIV RNA positive; AND
- Individuals with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart; AND
- Aged 18 years old or above.
- Written or verbal consent obtained
Exclusion criteria
- Refusal to consent
- Age < 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 1 center
- The Chinese University of Hong Kong — Hong Kong
Publications
- Lai JC, Wong GL, Wong VW, Yip TC. Unmet need in screening for hepatitis D virus: Time to take action. J Hepatol. 2024 Jun;80(6):e277-e278. doi: 10.1016/j.jhep.2023.12.006. Epub 2023 Dec 16. No abstract available. PMID 38110005
- Lui GC, Wong GL, Yang HC, Sheng WH, Lee SH. Current practice and recommendations for management of hepatitis B virus in people living with HIV in Asia. HIV Med. 2023 Oct;24(10):1035-1044. doi: 10.1111/hiv.13545. Epub 2023 Sep 21. PMID 37735948
Identifiers
NCT: NCT06889805 · SPEARHEAD 2024