Systematic review with meta-analysis: the efficacy and safety of tenofovir to prevent mother-to-child transmission of hepatitis B virus

M. H. Hyun, Y. S. Lee, J. H. Kim, J. H. Je, Y. J. Yoo, J. E. Yeon, K. S. Byun

Research output: Contribution to journalReview articlepeer-review

61 Citations (Scopus)


Background: Preventing mother to child transmission of chronic hepatitis B infection in the setting of a high maternal viral load is challenging. The idea has emerged from antepartum tenofovir treatment with combination immunoprophylaxis. Aims: To demonstrate the efficacy and safety of tenofovir to prevent mother to child transmission of hepatitis B virus. Methods: PubMed, EMBASE, and Cochrane databases were searched through August 16, 2016. Comparative trials of second or third trimester tenofovir administration vs. controls for patients with chronic hepatitis B infection and non-comparative case series assessing mother to child transmission rates and evaluating maternal and foetal safety outcomes were included. Results: Ten studies (one randomised controlled trial, four non-randomised controlled trials and five case series) that enrolled 733 women were included. The pooled results from comparative trials (599 pregnancies) showed that tenofovir significantly reduced the risk of infant hepatitis B surface antigen seropositivity by 77% (odds ratio=0.23, 95% confidence intervals=0.10-0.52, P=.0004) without heterogeneity (I2=0%). In the case series analysis (134 pregnancies), only two cases (1.5%) of mother to child transmission with extremely high maternal viral load and non-compliance to treatment were identified. Maternal and foetal safety parameters including congenital malformation and foetal death were re-assuring. Conclusions: For pregnant women with high hepatitis B virus DNA levels, tenofovir administration in the second or third trimester can prevent mother to child transmission when combined with hepatitis B immunoglobulin and the hepatitis B vaccine. Tenofovir is safe and tolerable for both the mother and foetus.

Original languageEnglish
Pages (from-to)1493-1505
Number of pages13
JournalAlimentary Pharmacology and Therapeutics
Issue number12
Publication statusPublished - 2017 Jun

Bibliographical note

Funding Information:
Funding information This study was funded in full by the National Research Foundation of Korea (NRF) grant funded by the Korea government (the Ministry of Education, Science and Technology) (2015R1C1A1A01052360). Declaration of personal interests: None.

Publisher Copyright:
© 2017 John Wiley & Sons Ltd

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)


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