Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 主要终点
- Incidence rates of a composite endpoint of hepatic events, including hepatocellular carcinoma (HCC), cirrhotic complications and liver-related death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with missing age and gender
- •Serious medical illnesses or malignancy with life expectancy <1 year
- •Age < 18 years
结局指标
主要结局
Incidence rates of a composite endpoint of hepatic events, including hepatocellular carcinoma (HCC), cirrhotic complications and liver-related death
时间窗: 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.
次要结局
- Economic burden(20 years)
- Partial HBV cure(20 years)
- Establish the most desirable cost range(20 years)
- Healthcare resources saving(20 years)
研究者
Grace Lai Hung Wong
Professor
Chinese University of Hong Kong