This project forms part of a larger NIHR RfPB funded programme, which aims to re-evaluate the treatment and management of chronic hepatitis B (CHB) in young people, in light of published national guidelines (NICE clinical guideline 165, 2013). These guidelines identified the need for further research to improve both the structure of patient investigation and the treatment evaluation of CHB in children and young people.
The proposed multicentre study, conducted over a three-year period, will evaluate the role of quantitative Hepatitis B surface antigen (qHBsAg) in defining disease phase and risk stratification in young patients with CHB. This work will address whether qHBsAg can enhance disease categorisation, leading to reductions in management costs and avoidance of unnecessary investigations and interventions.
The study will be retrospective-prospective in design and will be the largest cohort of CHB-infected young people ever assembled. In the first phase of the study, qHBsAg will be utilised in addition to routine clinical parameters, non-invasive markers of fibrosis and liver biopsy data from participating centres, to formulate a clinical predictor model that has been developed from preliminary data at The Royal London. In the second phase of the study, the clinical predictor model will be prospectively validated in more than 500 patients.
PenCHORD will provide the cost effectiveness analysis for the study. The aim here is to determine whether the new diagnostic procedures will provide more cost effective management of CHB in children and young people by addressing these specific questions:
- Does the predictor model reduce the need for more costly and invasive tests such as liver biopsy ?
- Does the predictor model improve monitoring by streamlining the frequency of clinic follow-up, thereby reducing the need for more regular monitoring in low-risk patients?
- Does the predictor model allow better patient selection for therapy initiation?
The researchers will use a cost-consequences model to show the potential benefits/costs of the different procedures. A range of scenarios and sensitivity analyses will be developed to cover the options for risk-stratification and to cope with the inevitable uncertainty in the data. There are likely to be a range of outputs, which are contingent on specific assumptions in the model. Work will determine if the predictor model:
- Reduces referral for costly/invasive tests
- Improves monitoring by streamlining frequency of hospital follow-up
- Decreases the need for regular clinic attendance in low-risk patients.
Anticipated Outputs and Impact
The wider project will transform services for children and young people with CHB. Currently, CHB in young people is poorly understood and poorly managed and as a consequence, patients are offered intense follow-up, resulting in overburdened clinics, adding to NHS costs. The UK has a large migrant community, centred primarily in London and Birmingham and this will be the largest cohort study of CHB in these patients ever undertaken, to tackle one of the most complex diseases in children and young people. The project has the potential to change the diagnostic processes used throughout the NHS for Hepatitis B.
The specific overall outcomes from this work will:
- Increase the awareness of CHB in young people, resulting in a positive impact on disease prevention and management;
- Provide a robust clinical assessment, using a predictor model of CHB in children and young people to streamline and improve monitoring;
- Develop the use of virtual/e-clinics as a cost-effective management strategy;
- Reduce the need for costly antiviral therapy in patients with low-risk disease;
- Develop a clinical predictor model for clinical practice and potentially offer a health app.