Reduced Mother-to-Child Transmission of Hepatitis B after Implementation of Completely Charge-Free Immunoprophylaxis in Mainland China

Background: Passive-active immunoprophylaxis with hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine is recommended to prevent mother-to-child transmission (MTCT) of hepatitis B virus (HBV). China has taken a policy to provide charge-free HBIG for infants of HBV-infected mothers since July 2011. We analyzed HBV infection rate in children of HBV-infected mothers born before and since July 2011 in real-life practice. Methods: Totally 5149 children of 5004 HBV-infected mothers, 1160 children born before July 2011 and 3989 children born since July 2011, across Jiangsu province, China, were followed up for HBV markers at 0⋅6-8 years age from 2009 to 2018. Findings: Totally 92 children were HBsAg positive, with an overall infection rate 1⋅79%. MTCT occurred in 0% of 3716 children of hepatitis B e antigen (HBeAg)-negative mothers, and in 6⋅42% of 1433 children of HBeAg-positive mothers (p<0⋅0001). Among 1433 children of HBeAg-positive mothers, transmission occurred in 10⋅27% born before July 2011 and 5⋅5% born since July 2011 (p=0⋅0221); HBIG and vaccine were timely administered in 76⋅47% and 92⋅67% of children born before July 2011 respectively, and in 98⋅02% and 98⋅32% of those born since July 2011 respectively (each p<0⋅0001). Among 1433 children of HBeAg-positive mothers, MTCT occurred in 75 (5⋅54%) of 1355 children with recommended immunoprophylaxis, and in 17 (21⋅79%) of 78 children not per recommended immunoprophylaxis (p<0⋅0001). The lowest HBV DNA level associated with transmission was 3⋅08ₓ106 IU/mL. Interpretation: In addition to maternal HBeAg positive, inappropriate administration of HBIG and/or hepatitis B vaccine is a critical risk for MTCT of HBV in children of HBV-infected mothers. Implementation of charge-free HBIG in infants of HBsAg-positive mothers greatly reduces transmission of HBV. Maternal HBeAg negative or HBV DNA ≤106 IU/mL requires no other interventions to prevent MTCT. Funding Statement: This study was supported by the National Health Commission of China (National Key Clinical Research Project 2011271), the National Natural Science Foundation of China (81672002), the Jiangsu Provincial Health Commission (H201537, XK201607), and the Science and Technology Department of Jiangsu Province (BK20161105), China. Declaration of Interests: The authors declare no conflict of interest. Ethical Approval Statement: The present study was approved by the institutional review board of ethics committee in each hospital. Written informed consent was from the mothers or guardians, who also signed the informed consent for children.