Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort
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: Chronic Hepatitis B. 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Incidence rates of a composite endpoint of hepatic events, including hepatocellular carcinoma (HCC), cirrhotic complications and liver-related death [Time frame: 20 years]
Secondary outcome measures (4)
- Economic burden [Time frame: 20 years]
- Partial HBV cure [Time frame: 20 years]
- Establish the most desirable cost range [Time frame: 20 years]
- Healthcare resources saving [Time frame: 20 years]
Eligibility criteria
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
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06627608 · CEA for HBV cure