Chronic Hepatitis B
Conditions
Keywords
Cost-Effectiveness Analysis, HBV Cure
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Chinese University of Hong Kong
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Patients achieved HBV cure, i.e. HBsAg turned negative 3. Aged 18 years old or above.
Exclusion criteria
1. Patients with missing age and gender 2. Serious medical illnesses or malignancy with life expectancy <1 year 3. Age < 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rates of a composite endpoint of hepatic events, including hepatocellular carcinoma (HCC), cirrhotic complications and liver-related death | 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
| Measure | Time frame | Description |
|---|---|---|
| Economic burden | 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. |
| Partial HBV cure | 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. |
| Establish the most desirable cost range | 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). |
| Healthcare resources saving | 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. |
Contacts
Primary ContactAngel Chim, MSc
Backup ContactGrace Wong, MD
Outcome results
None listed