Chronic Hepatitis B Infection Clinical Trial
Official title:
Quality of Life and Health Utility of Patients With Chronic Hepatitis B Infections
The aim of the study is to assess the health-related quality of life (HRQOL) and
preference-based health utilities of chronic hepatitis B (CHB) carriers in different stages
of illness. It will also estimate the cost-effectiveness of anti-viral treatments resulting
from the prevention of the progression of disease from uncomplicated CHB carriers to
cirrhosis and hepatocellular carcinoma (HCC).
The following hypotheses will be tested:
1. Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life
(HRQOL) than the general population;
2. Patients with more severe stages of chronic HB infections have lower health related
quality of life and health utility values;
3. Anti-viral treatment can improve the HRQOL and health utility for patients with CHB
infections;
4. The cost-effectiveness of different treatments for chronic HBV infections can be
directly compared in terms of cost/QALY gained.
Design, Setting & Subjects: A cross-sectional study and biomathematical modelling will be
carried out. In the cross-sectional study, patients known to CHB carriers will be identified
from the registries of the Ap Lei Chau, Aberdeen and Sai Yung Pun General Outpatient Clinics
and Queen Mary Hospital. The biomathematical modelling will use a simulated cohort of
patients aged 18 or above with CHB infections who may receive treatment in Hong Kong.
Published data on the benefit of anti-viral treatments and the cross-sectional study data on
preference-based health utility values of different stages of CHB infections will be used to
estimate the cost-effectiveness of different treatment strategies using Markov modelling.
Interventions: Each subject in the cross-sectional study will be interviewed. Five strategies
for management of CHB infections: 1) No treatment, 2) Interferon monotherapy, 3) lamivudine
monotherapy, 4) adefovir and 5) combined treatment of lamivudine and adefovir, will be tested
in the biomathematical modelling,.
Main Outcome Measures: Health-related quality of life measured by the SF-36, preference-based
health utilities measured by the SF-6D. quality adjusted life years (QALYs) and cost of
different treatment strategies for HBV infection.
Hypothesis: HRQOL and health utilities of patients with different illness stages, and the
QALYs gained and cost-effectiveness of different therapeutic strategies will be established.
The results will provide information on the health burden of CHB infections, and evidence on
the cost-effectiveness of anti-viral treatments in preventing disease progression can be
directly compared.
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