Abstract

BackgroundHepatitis B is a highly prevalent disease. About 257 million people are infected with hepatitis B virus (HBV), and more than 887 000 annual new acute or chronic cases of hepatitis B are recorded globally. HBV infection is also highly prevalent in China, where around 60 million people are positive for HBV antigens, and about 20 million people have chronic HBV infection. The Chinese government launched the national hepatitis B immunisation programme in 2002 that provides vaccination free of charge. Our study aimed to establish the effects of neonatal hepatitis B vaccine in China. MethodsFor our analysis, we obtained data on HBV infection cases from the China Epidemic Data Collection System and the China Public Health science data centre; data on costs related to HBV infection were acquired from a survey of the Evaluation Project of the National Immunisation Programme of China. We used a mathematical model and a decision tree-Markov model in this modelling study. In the mathematical model, nine compartments were expanded from a typical susceptible-exposed-infected-recovered model. In the decision tree-Markov model, eight Markov states were included to simulate hepatitis B virus infection and progression. We compared various intervention scenarios to establish the effects and cost-effectiveness of hepatitis B vaccination through the primary outcome of the study, incidence of HBV infection cases, which could provide evidence for exploring new prevention and control strategies. FindingsOur study estimated the number of chronic HBV infection cases from 1998 to 2018, and projected the prevalence of the epidemic in the following 30 years. Since the expanded immunisation plan began in 2008, the number of new acute hepatitis B cases decreased by 56·02% in 2018. Comparing the first scenario (status quo) with the second scenario (without any prior intervention), the model estimated that new chronic HBV infection cases have reduced by 95·13%. In other words, about 20·97 million new chronic HBV infection cases were averted because of hepatitis B vaccination. The cost-effectiveness analysis showed that the implementation of the neonatal hepatitis B vaccine strategy could increase effectiveness by 1·77 quality-adjusted life years (QALY) per capita; and although each person obtained a unit of QALY, the cost for the whole of society was a saving of US$8142·29. InterpretationOur findings supported the effectiveness of HBV vaccination in controlling the epidemic of hepatitis B after about 20 years of implementation of the national hepatitis B immunisation programme. Although China has achieved a great deal in hepatitis B prevention, the burden of this disease remains quite heavy in China, especially in terms of mother-to-child transmission. Therefore, more strategies need to be explored for controlling and eventually eliminating hepatitis B. FundingEvaluation Project of the National Immunisation Programme of China.

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