| Objective:To understand the persistence of adult immunization after hepatitis B vaccine,and to explore whether adult requires booster immunization.Furthermore,to explore whether booster vaccination with hepatitis B vaccine in adults is cost-effective and affordable.The results can provide relevant recommendations for expanding the implementation strategy of adult hepatitis B immunization and effectively controlling the incidence of new adult hepatitis B infections in China.Methods:Study on Hepatitis B immune persistence in adults: In the observation queue of the National Demonstration Areas in China for the Integrated Control of Infectious Diseases,the study subjects were selected from individuals over 18 years old who had completed the full course of immunization according to the 0-1-6 month standard procedure for primary immunization,and met the inclusion and exclusion criteria.The study population was divided into three groups: one year after primary immunization(Y1),five years after primary immunization(Y5),and ten years after primary immunization(Y10),each group consisting of 200 people,for a total of 600 people.A questionnaire survey was conducted on the study subjects on-site,and blood samples were collected and tested for hepatitis B surface antigen(HBsAg),hepatitis B surface antibody(anti-HBs),and hepatitis B core antibody(anti-HBc).The positive rate of anti-HBsand geometric mean concentration(GMC)of anti-HBswere compared among different groups.Health economic evaluation: A decision tree-Markov model was established for the economic evaluation of adult hepatitis B based on the data obtained from the first part of the study on long-term immunity,combined with survey data from the "Thirteenth Five-Year Plan" project in Chaoyang District,Beijing.Relevant disease outcomes,utility,and cost parameters were identified through literature search.A research cohort of100,000 adults aged 18 years and above in Chaoyang District was simulated,and three immunization strategies including primary immunization,booster immunization,and no immunization were compared over a 20-cycle simulation.The effects and utilities of different interventions were compared from the perspectives of payers,medical and health care,and the whole society.The effects were represented by the number of people in the simulated cohort who avoided hepatitis B related diseases and deaths,while the utility was represented by quality-adjusted life years(QALYs).A cost utility analysis(CUA)was used to compare the cost-effectiveness of different strategies,and an incremental cost-effectiveness ratio(ICER)was calculated.One-way sensitivity analysis and probabilistic sensitivity analysis were used to examine the sensitivity and impact of parameters.Results:Study on Hepatitis B Immune Persistence in adults: 1.The positive rates of HBsAg,anti-HBsand anti-HBc for all 600 subjects were 0,70.50% and 2.50% respectively.2.The positive rates of anti-HBsin Y1,Y5 and Y10 groups were 86.50%,71.00% and54.00%,respectively(χ ~2=50.82,P<0.001).The positive rate of anti-HBsdecreased linearly with the extension of immunization time(trend χ~2=50.70,P<0.001).3.The positive rates of anti-HBc were 1.00%,3.00%,and 3.50% in the Y1,Y5,and Y10 groups,respectively.The positive individuals in Y1 and Y5 groups were double positive for anti-HBsand anti-HBc,and in Y10 group there were 4 single positive individuals for anti-HBc and 3 double positive individuals for anti-HBsand anti-HBc.4.The GMC(mIU/ml)in Y1,Y5 and Y10 groups were 296.55,51.64 and 25.46,respectively(H=64.76,P<0.001).5.The positive rate and GMC of anti-HBsin the population aged60 years and above are lower than those in the population under 60 years old(χ~2=10.39,P<0.001)(Z=1.62,P=0.011).In the Y1,Y5,and Y10 groups,the positive rates of anti-HBsin the population aged 60 years and above are 87.50%,62.38%,and 49.33%,and the anti-HBsGMC(mIU/ml)are 365.94,39.07,and 16.04,respectively.In the population under 60 years old,the positive rates of anti-HBsare 86.25%,79.80%,and56.80%,and the anti-HBsGMC(mIU/ml)are 306.47,64.30,and 33.18,respectively.Health economic evaluation: 1.Markov chain analysis showed that compared to the population without intervention,basic immunization could prevent 2022 cases of Hepatitis B virus(HBV)infection,1412 cases of HBV carrier,463 cases of chronic Hepatitis B(CHB),47 cases of compensated cirrhosis,11 case of decompensated cirrhosis,12 case of hepatocellular carcinoma,and 78 deaths.Strengthened immunization strategy compared to basic immunization could prevent 256 cases of HBV infection,207 cases of HBV carrier,44 cases of CHB,4 cases of compensated cirrhosis,1 case of decompensated cirrhosis,2 cases of hepatocellular carcinoma,and 4 deaths.2.CUA showed that from the payer’s perspective,the incremental cost-effectiveness ratio(ICER)of basic immunization compared to no intervention was 2834.34,and the ICER of strengthened immunization compared to basic immunization was 4293.87.From the healthcare perspective,the ICER of basic immunization compared to no intervention was-24385.14,and the ICER of strengthened immunization compared to basic immunization was-28005.18.From the societal perspective,the ICER of basic immunization compared to no intervention was-28697.57,and the ICER of strengthened immunization compared to basic immunization was-31580.15.3.Sensitivity analysis showed that the results were stable and reliable across all perspectives,with vaccine efficacy,discount rate,vaccine cost,screening cost,and costs related to HBV-related diseases(acute HBV,chronic carrier,and CHB)being the main factors affecting ICER.Conclusions:1.Adults who have received the basic immunization of hepatitis B vaccine will obtain better immune protection,and within 10 years,there will be no cases of HBsAg positive infection.2.The positive rate of anti-HBsand anti-HBsGMC decrease rapidly after adult vaccination with the hepatitis B vaccine.Therefore,it is recommended to conduct antibody level testing 5-10 years after the completion of the initial immunization schedule in adults.For individuals with antibody levels below the protective level,hepatitis B vaccine booster immunization is recommended.3.The immunization effect is better in younger age groups,and the immunization persistence is better in individuals younger than 60 years old than in those older than 60 years old.4.Hepatitis B immunization in adults has high cost utility.Under the premise of obtaining more QALY,a large amount of costs can be saved.5.Compared with basic immunization,for every additional QALY gained,a savings of 31580.15 yuan can be achieved by booster immunization,making it a preferred strategy. |
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