Progress towards elimination of mother-to-child transmission of hepatitis B virus infection in China: a modelling analysis.

OBJECTIVE: To determine the projected burden of hepatitis B virus (HBV) in China, the intervention strategies that can eliminate mother-to-child transmission (MTCT) by 2030 or earlier and the measurable parameters that can be used to monitor progress towards this target. METHODS: We developed a dynamic, sex- and age-stratified model of the HBV epidemic in China, calibrated using hepatitis B surface antigen (HBsAg) and e antigen (HBeAg) prevalence data from sequential national serosurveys (1979-2014) and the numbers of HBV-related cancer deaths (2012). We determined whether China can achieve elimination of MTCT of HBV by 2030 under current prevention interventions. We modelled various intervention scenarios to represent different coverage levels of birth-dose HBV vaccination, hepatitis B immunoglobulin to newborns of HBsAg-positive mothers and antiviral therapy (tenofovir) to HBeAg-positive pregnant women. FINDINGS: We project that, if current levels of prevention interventions are maintained, China will achieve the elimination target by 2029. By modelling various intervention scenarios, we found that this can be brought forward to 2025 by increasing coverage of birth-dose vaccination, or to 2024 by the administration of tenofovir to HBeAg-positive pregnant women. We found that achievement of the target by 2025 would be predicted by a measurement of less than 2% MTCT in 2020. CONCLUSION: Our results highlight how high-quality national data can be combined with modelling in monitoring the elimination of MTCT of HBV. By demonstrating the impact of increased interventions on target achievement dates, we anticipate that other high-burden countries will be motivated to strengthen HBV prevention policies.

New progress in HBV control and the cascade of health care for people living with HBV in China: evidence from the fourth national serological survey, 2020.

Background: Since 1992, when recombinant hepatitis B vaccine was introduced in China, government health officials have used nationally representative serological surveys to monitor progress in prevention and control of hepatitis B. In 2020, we conducted the fourth seroepidemiological survey, which for the first time included medical evaluation of the clinical status of HBsAg positive subjects over the age of 15 and their medical management. We report survey results in comparison with the three previous surveys. Methods: Consistent with previous national surveys, the 2020 survey used a stratified, three-stage cluster random sampling method to select for evaluation 1-69-year-olds in 120 national disease surveillance points. Blood samples were tested for HBsAg, anti-HBV surface antigen (anti-HBs), and anti-HBV core antigen (anti-HBc) in the National Hepatitis Laboratory of the Institute for Viral Disease Control and Prevention of China CDC. HBsAg positive subjects aged ≥15-year were evaluated for evidence of liver disease, and through face-to-face questionnaire-based survey, we determined the healthcare management cascade of HBV-infected individuals. Findings: HBsAg prevalence in 1-69-year-olds was 5.86%; in children 1-4 years of age, seroprevalence was 0.30%; 75 million people were living with HBV nationwide. Among HBsAg-positive individuals 15 years and older, expert medical examination found that 78.03% were HBsAg carriers with no evidence of liver damage, 19.63% had chronic HBV with liver enzyme abnormalities, 0.84% had evidence of cirrhosis, and 0.15% had evidence of liver cancer. 59.78% of HBsAg + individuals were aware that they were positive before the survey, 30 million were unaware; 38.25% of those who knew they were positive (17 million) had medical indications for antiviral treatment, and 17.33% of these individuals (3 million) were being treated with antivirals. Interpretation: The decline in HBsAg prevalence in the general population, from 9.72% in 1992 to 5.86% in 2020, and in 1-4-year-olds from 9.67% in 1992 to 0.30% in 2020, shows progress that continues on track toward WHO targets for prevention of new infections. Implementation of acceptable strategies to identify infected individuals and offer long-term medical monitoring and management will be important to prevent complications from hepatitis B infection and for meeting WHO cascade-of-care targets. Funding: The study was funded by the Major Science and Technology Special Project of China's 13th 5-Year Plan (grant no. 2017ZX10105015); Central finance-operation of public health emergency response mechanism of Chinese Center for Disease Control and Prevention (131031001000200001, 102393220020010000017).

Long-term seropositivity, safety, and impact of inactivated and live, attenuated hepatitis a vaccines in China - A cross-sectional study.

BACKGROUND: In 2008, China introduced live, attenuated hepatitis A vaccine (L-HepA, licensed in 1992) and inactivated hepatitis A vaccine (I-HepA, licensed in 2002) nationwide, and is currently the only country using L-HepA in routine immunization. We assessed seropositivity and its duration following vaccination, safety, and association with hepatitis A incidence and population seroprevalence for I-HepA and L-HepA. METHODS: We obtained seroprevalence data from two nationwide serosurveys (in 1992 and 2014), vaccination status from the 2014 serosurvey, and vaccine safety and disease incidence data from the national surveillance system. We compared long-term HAV seropositivity among vaccine recipients and described safety profiles of both vaccines. We categorized the 31 provinces into those predominately using I-HepA and achieving high coverage (n = 4), those predominately using L-HepA achieving high coverage (n = 4), and those predominately using L-HepA achieving lower coverage (n = 23). We compared population HAV seropositivity, coverage, and disease incidence among the three groups. RESULTS: One year after vaccination, seropositivity from I-HepA was significantly higher than from L-HepA (97.8% vs 90.7%), and seropositivity declined to 73.5% for L-HepA and 75.4% for I-HepA after 10 years - not significantly different by vaccine. The annual incidence of serious AEFI was <0.5/100 000 for both vaccines. Prior to licensure of either HepA vaccine, provinces that would go on to predominantly use I-HepA had lower incidences of hepatitis A and lower seropositivity levels to HAV than provinces that would go on to use L-HepA. By 2014, these differences were significantly diminished. Regardless of vaccine selection, all three province groups had lower immunity to HAV among individuals born during the 10 years prior to nationwide vaccine introduction - individuals who were 10 to 24 years old in 2014. CONCLUSION: Evidence of good immunogenicity, safety, and impact on incidence supports continued use of both I-HepA and L-HepA in the EPI system. These results may be useful for countries considering integrating HepA vaccines into their routine programs.