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NCT Number: NCT06627608

Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort

A number of hepatitis B virus (HBV) cure regimens including antisense oligonucleotide (ASO) and small interfering RNA (siRNA) are under vigorous clinical development and the efficacy and safety will soon be available for regulatory approval. Patients most in need should be prioritised to receive HBV cure regimen to maximise its clinical benefits and speed up hepatitis elimination.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

A territory-wide cohort study of all patients with chronic hepatitis B who have achieved functional cure of HBV. Real-world data will be used to estimate the risk of HCC, hepatic decompensation, and liver-related death for the subsequent simulation of HCC risk in particular populations of patients who achieved HBV cure. Literature search also be performed in parallel to cross-validate the estimates in untreated patients, and treated patients with incomplete or complete viral suppression with different stages of fibrosis based on existing literature. An optional systematic review and meta-analysis may be performed the address these issues.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart, AND
  • Patients achieved HBV cure, i.e. HBsAg turned negative
  • Aged 18 years old or above.

Exclusion criteria

  • Patients with missing age and gender
  • Serious medical illnesses or malignancy with life expectancy <1 year
  • Age < 18 years

Treatment and study plan

Primary outcomes

  1. Incidence rates of a composite endpoint of hepatic events, including hepatocellular carcinoma (HCC), cirrhotic complications and liver-related death

    Time frame: 20 years

    This would be the first step to get the estimated incidence rates of these clinical events to facilitate to subsequent modelling of the impact of different estimated rates of HBV cure on the overall incidence of liver outcomes.

Secondary outcomes

  1. Economic burden

    Time frame: 20 years

    To determine the economic burden for managing HCC, hepatic event and liver-related death after an different possible increased rate of functional cure under new HBV cure regimens.

  2. Partial HBV cure

    Time frame: 20 years

    To evaluate the impact of increased partial cure (sustained HBV DNA suppression without HBsAg loss after completing a finite course of antiviral treatment) on the incidence of HCC, hepatic event and liver-related death after an different possible reduction of HBsAg levels under new HBV cure regimens.

  3. Establish the most desirable cost range

    Time frame: 20 years

    To establish the most desirable cost range for the first approved HBV cure regimen using Hong Kong and the Greater Bay Area (GBA) as the examples (with the healthcare cost variations in different regions of GBA taken into account).

  4. Healthcare resources saving

    Time frame: 20 years

    To determine the healthcare resources saving from the reduced incidence of HCC, hepatic event and liver-related death after an different possible increased rate of functional cure under new HBV cure regimens.

Study contacts

Contact information is provided by the study sponsor or research team.

Angel Chim, MSc

CONTACT

[email protected]

4076686013

Grace Wong, MD

CONTACT

[email protected]

4076686013

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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