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Efficacy and safety of tenofovir alafenamide fumarate for preventing mother‐to‐child transmission of hepatitis B virus: a national cohort study
Author(s) -
Ding Yang,
Cao Lihua,
Zhu Liying,
Huang Yan,
Lin Chaoshuang,
Wang Yuming,
Liu Yingxia,
Sheng Qiuju,
Wang Shouyun,
Fan Jian,
Chen Ruochan,
Gan Weiqiang,
Chen Bryan,
Pan Calvin Q.
Publication year - 2020
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.16043
Subject(s) - medicine , tenofovir alafenamide , hepatitis b virus , hepatitis b , adverse effect , pediatrics , transmission (telecommunications) , immunology , viral load , virus , antiretroviral therapy , electrical engineering , engineering
Summary Background Data on tenofovir alafenamide fumarate (TAF) for preventing mother‐to‐child transmission of hepatitis B virus (HBV) are lacking. Aims To investigate the efficacy and safety of TAF therapy for preventing hepatitis B mother‐to‐child transmission. Methods Mothers with chronic HBV infection, positive for hepatitis B e‐antigen and with HBV DNA >200 000 IU/mL received TAF for preventing mother‐to‐child transmission were enrolled retrospectively from multiple centres with data collection on mother‐infant dyads up to postpartum week 24‐28. Primary measurements were the mother‐to‐child transmission rate and infants' malformation rate. Secondary assessments included maternal HBV DNA reduction at delivery, and maternal or infant adverse events during follow up. Results Among 71 mothers enrolled, the mean (±SD) age was 30.3 (±2.2) years. TAF was initiated during the second or third trimester and continued to delivery with a mean (±SD) duration of 12.8 (±4.0) weeks. At delivery, 85.9% (61/71) of the mothers achieved HBV DNA <200 000 IU/L. Seventy‐three infants (two sets of twins) were born from mothers treated with TAF and none had congenital defects or malformations. All infants received HBV immunoglobulin and vaccine at birth with additional HBV vaccinations at one and six months. At age 24‐28 weeks, all infants had negative hepatitis B surface antigen and undetectable levels of HBV DNA (<100 IU/mL). Body weight, height, and head circumferences were comparable to national standards for physical development. No severe adverse effects were reported in either mothers or infants. Conclusions TAF for highly viraemic mothers effectively prevented mother‐to‐child transmission of hepatitis B. There were no safety concerns for either mothers or infants with 24‐28 weeks of follow up.