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Effectiveness and Safety of Tenofovir Alafenamide Fumarate in the Prevention of Perinatal Hepatitis B Transmission: A Meta-Analysis

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Abstract

Aim

This study aimed to assess the effectiveness and safety of tenofovir alafenamide fumarate (TAF) in the prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV).

Methods

We performed a meta-analysis of studies from the Cochrane Library, PubMed, ClinicalTrials.gov, Web of Science, EMBASE, China National Knowledge Infrastructure (CNKI), China Medical Information Network, and Wanfang databases. The databases were searched from inception to January 7, 2023, for cohort studies and randomized controlled trials (RCTs) comparing the use of TAF antivirals to other antivirals during pregnancy. We combined the data by means of a random-effect DerSimonian-Laird model and risk ratios (RRs) or a random-effect inverse variance model and standardized mean differences (SMDs) to determine the influence on mothers and infants. Our primary outcomes were infant weight, height, head size, birth defects, and Apgar scores. Additionally, we assessed whether newborns tested positive for hepatitis B surface antigen (HBsAg) at birth and at six months of age. The secondary outcomes of our investigation were alterations in levels of HBV deoxyribonucleic acid (DNA), alanine aminotransferase (ALT), total bilirubin (TBIL), blood creatinine, and urine β2-microglobulin (β2-M) in mothers.

Results

An extensive literature search identified 216 relevant publications; three cohort studies and two RCTs were included in this study. A total of 341 mothers were treated with TAF, and 342 were treated with other antiviral agents. TAF was as effective as other antiviral medications at lowering HBV MTCT rates at birth and at 6 months of age and ALT, TBIL, and HBV DNA levels. Moreover, compared with other antiviral drugs, TAF did not affect infant weight, height, head size, Apgar scores, and birth defects or maternal blood creatinine or β2-M levels.

Conclusions

TAF antiviral therapy during pregnancy was found to be safe for both mothers and fetuses.

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Acknowledgments

This project was supported by the project of Ganzhou Municipal Health Commission of Jiangxi Province (2020-2-43), the projects of Science and Technology of Ganzhou City, Jiangxi Province (GZ2020ZSF179 and GZ2020ZSF180), and Jiangxi Provincial Bureau of Traditional Chinese Medicine (2020B0117 and 2023A0198).

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Author notes

  1. Ji Huang, Cong Cheng, and Kangxin Li contributed equally to this work.

Authors and Affiliations

  1. Department of Gastroenterology, Ganzhou People’s Hospital, Ganzhou, China

    Kangxin Li, Chunping Zhu & Youshun Liu

  2. Department of Traditional Chinese Medicine, Ganzhou People’s Hospital, Ganzhou, China

    Ji Huang

  3. Department of Infectious Disease, Successful Hospital Affiliated to Xiamen University, Xiamen, China

    Cong Cheng

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  1. Ji Huang
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  2. Cong Cheng
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Correspondence to Youshun Liu.

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Huang, J., Cheng, C., Li, K. et al. Effectiveness and Safety of Tenofovir Alafenamide Fumarate in the Prevention of Perinatal Hepatitis B Transmission: A Meta-Analysis. Dig Dis Sci 69, 978–988 (2024). https://doi.org/10.1007/s10620-023-08258-9

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