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

36 Pages Posted: 3 May 2019

See all articles by Zhihua Liu

Zhihua Liu

Southern Medical University - Department of Infectious Diseases

Xueru Yin

Southern Medical University - Department of Infectious Diseases

Guorong Han

Southeast University

Hua Zhang

Capital Medical University - Beijing YouAn Hospital

Mei Wang

Government of the People's Republic of China - Fifth Medical Centre

Wenjun Zhang

Southern Medical University - Fifth Affiliated Hospita

Yunfei Gao

Southern Medical University - Department of Gynaecology and Obstetrics

Mei Zhong

Southern Medical University - Department of Gynaecology and Obstetrics

Xiaolan Wang

Jiujiang Maternal and Child Care Center

Xiaozhu Zhong

Southern Medical University, Zhujiang Hospital

Guojun Shen

Third People’s Hospital of Jiujiang

Chuangguo Yang

Southern Medical University - Third Affiliated Hospital

Huiyuan Liu

Guangzhou Medical University - Guangzhou Eighth People's Hospital

Zhihong Liu

Southern Medical University - Department of Infectious Diseases; Guangdong Academy of Sciences (GDAS) - State Key Laboratory of Applied Microbiology in Southern China

Po-Lin Chan

World Health Organization (WHO) - Western Pacific Region (WPRO)

Marc Bulterys

World Health Organization (WHO)

Fuqiang Cui

Peking University, School of Public Health, Department of Laboratorial Science and Technology ; Peking University, School of Public Health, Vaccine Research Center

Hui Zhuang

Peking University - Department of Microbiology and Infectious Disease

Jinlin Hou

Southern Medical University - State Key Laboratory of Organ Failure Research

More...

Abstract

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.

Suggested Citation

Liu, Zhihua and Yin, Xueru and Han, Guorong and Zhang, Hua and Wang, Mei and Zhang, Wenjun and Gao, Yunfei and Zhong, Mei and Wang, Xiaolan and Zhong, Xiaozhu and Shen, Guojun and Yang, Chuangguo and Liu, Huiyuan and Liu, Zhihong and Chan, Po-Lin and Bulterys, Marc and Cui, Fuqiang and Zhuang, Hui and Hou, Jinlin, A Real-World Prospective Study of Mother-to-Child Transmission of Hepatitis B Virus in China Using a Mobile Health Application (Shield 01) (April 27, 2019). Available at SSRN: https://ssrn.com/abstract=3379817 or http://dx.doi.org/10.2139/ssrn.3379817

Zhihua Liu

Southern Medical University - Department of Infectious Diseases

Guangdong
China

Xueru Yin

Southern Medical University - Department of Infectious Diseases

Guangdong
China

Guorong Han

Southeast University

Sipailou 2#
Nanjing, Jiangsu Province 210096
China

Hua Zhang

Capital Medical University - Beijing YouAn Hospital

Beijing, 100069
China

Mei Wang

Government of the People's Republic of China - Fifth Medical Centre

Beijing
China

Wenjun Zhang

Southern Medical University - Fifth Affiliated Hospita

Guangzhou, Guangdong Province
China

Yunfei Gao

Southern Medical University - Department of Gynaecology and Obstetrics

Guangzhou
China

Mei Zhong

Southern Medical University - Department of Gynaecology and Obstetrics

Guangzhou
China

Xiaolan Wang

Jiujiang Maternal and Child Care Center

China

Xiaozhu Zhong

Southern Medical University, Zhujiang Hospital

Guangzhou, Guangdong Province
China

Guojun Shen

Third People’s Hospital of Jiujiang

China

Chuangguo Yang

Southern Medical University - Third Affiliated Hospital

Guangdong Province
China

Huiyuan Liu

Guangzhou Medical University - Guangzhou Eighth People's Hospital

Guangzhou, 510080
China

Zhihong Liu

Southern Medical University - Department of Infectious Diseases

Guangdong
China

Guangdong Academy of Sciences (GDAS) - State Key Laboratory of Applied Microbiology in Southern China

Guangzhou, 510070
China

Po-Lin Chan

World Health Organization (WHO) - Western Pacific Region (WPRO)

20 Avenue Appia
Geneva 27, CH-1211
Switzerland

Marc Bulterys

World Health Organization (WHO)

20 Avenue Appia
Geneva 27, CH-1211
Switzerland

Fuqiang Cui

Peking University, School of Public Health, Department of Laboratorial Science and Technology ( email )

No. 38 Xueyuan Road
Haidian District
Beijing, Beijing 100871
China

Peking University, School of Public Health, Vaccine Research Center ( email )

China

Hui Zhuang

Peking University - Department of Microbiology and Infectious Disease

Beijing, 100191
China

Jinlin Hou (Contact Author)

Southern Medical University - State Key Laboratory of Organ Failure Research ( email )

Guangzhou, Guangdong Province
China