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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates of a composite endpoint of hepatic events, including hepatocellular carcinoma (HCC), cirrhotic complications and liver-related death | 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. | 20 years |
| Measure | Description | Time Frame |
|---|---|---|
| Economic burden | 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. | 20 years |
| Partial HBV cure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angel Chim, MSc | Contact | 4076686013 | angelchim@cuhk.edu.hk | |
| Grace Wong, MD | Contact | 4076686013 | wonglaihung@cuhk.edu.hk |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
| 20 years |
| Establish the most desirable cost range | 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). | 20 years |
| Healthcare resources saving | 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. | 20 years |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |