A Real-World Prospective Study of Mother-to-Child Transmission of Hepatitis B Virus in China Using a Mobile Health Application (Shield 01)

Background: The World Health Organization (WHO) has set a goal of eliminating viral hepatitis as public health threat by 2030. To assess feasibility of this goal in China, we carried out a real-world study to determine whether WHO's goal could be achieved. Methods: One thousand and eight hepatitis B surface antigen (HBsAg) positive pregnant women were enrolled at ten hospitals. Immunoprophylaxis was routinely administered to infants. In addition, mothers with HBV DNA level > 2,000,000 IU per milliliter were advised to initiate antiviral therapy during late pregnancy. A health application called SHIELD was used to manage the study. Findings: Nine hundred and five of enrolled mothers with 924 infants completed the follow-up, including 561 hepatitis B e antigen (HBeAg) positive mothers and 499 mothers with HBV DNA level > 2,000,000 IU per milliliter. There were 446 mothers who received antiviral therapy, including 72·3% of the mothers with HBV DNA level > 2,000,000 IU per millilitre and 21·0% of the mothers with HBV DNA level of < 2,000,000 IU per millilitre. Birth-dose hepatitis B vaccine (HepB) and hepatitis B immunoglobulin (HBIG) were received by 99·9% and 99·8% of infants within 24 hours after birth, respectively. Eight infants became infected with HBV. The overall rate of mother-to-child transmission (MTCT) was 0·9% (95% confidence interval, 0·4% to 1·7%). Birth defects were rare (0·5% among infants with maternal antiviral exposure versus 0·7% among infants without exposure; P=1·00). Interpretation: In real-world practice, there was a low rate (<1%) of MTCT with administration of combined immunoprophylaxis to infants, and initiation of maternal antiviral therapy during pregnancy among a subset of mothers with high HBV viral load. This study suggested that a comprehensive management composing of immunoprophylaxis to infants and antiviral prophylaxis to mothers was a feasible strategy in China which may accelerate achieving the WHO goal of eliminating the MTCT of HBV. Funding: This work was funded by China Foundation for Hepatitis Prevention and Control (CFHPC) and National Natural Science Foundation of China (Grant No.81673243). Declaration of Interest: JH is a consultant for AbbVie, Arbutus, Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson, and Roche, and received grants from Bristol Myers Squibb, Johnson & Johnson, and Gilead science, all outside the submitted work. The remaining authors declare no competing interests. Ethical Approval: The study protocol was approved by the ethics committee at each participating centre.