|Title:||Long-term growth and bone development in children of HBV-infected mothers with and without fetal exposure to tenofovir disoproxil fumarate||Authors:||Wen W.-H.
TIFFANY TING-FANG SHIH
Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study)
|Issue Date:||2020||Publisher:||Elsevier B.V.||Journal Volume:||72||Journal Issue:||6||Start page/Pages:||1082-1087||Source:||Journal of Hepatology||Abstract:||
Background & Aims: Tenofovir disoproxil fumarate (TDF) is the preferred treatment to prevent maternal transmission of HBV, owing to its efficacy and safety. However, data are lacking on the long-term safety outcomes in children following fetal exposure to TDF. Methods: Children participating in a prospective, multisite trial of maternal TDF treatment during late pregnancy were recruited for follow-up visits once a year. Growth parameters, serum biochemistry, HBV serology, and bone mineral density (BMD) by dual-energy x-ray absorptiometery scan were measured. Results: One hundred and twenty-eight children, 71 in the TDF and 57 in the control group, completed 255 follow-up visits at the age of 2 to 7 (median, 4.08) years. No differences in z-scores for weight-for-age (0.26 ± 0.90 vs. 0.22 ± 0.99, p = 0.481), z-scores for height-for-age (0.20 ± 1.02 vs. 0.25 ± 0.98, p = 0.812), and estimated glomerular filtration rate (169.12 ± 50.48 vs. 169.06 ± 34.46 ml/min/1.73m2, p = 0.479) were detected. After adjustment for age, sex and HBV status by multiple linear regression, children in the TDF and control group had comparable levels of serum calcium, phosphorus, bone-specific alkaline phosphatase, calcidiol and BMD of lumbar spines (0.55 ± 0.01 vs. 0.57 ± 0.01 g/cm2, p = 0.159) and left hip (0.56 ± 0.01 vs. 0.56 ± 0.01 g/cm2, p = 0.926). Conclusions: Children of HBV-infected mothers who did or did not receive tenofovir disoproxil fumarate treatment during late pregnancy had comparable long-term growth, renal function, and bone development up to 6–7 years after delivery. Clinical trial number: NCT01312012 (ClinicalTrials.gov) Lay summary: Currently there are insufficient long-term safety data in children born to mothers who took antiviral agents during pregnancy to prevent mother-to-infant transmission of hepatitis B virus (HBV). In this study, we found that children of HBV-infected mothers who did or did not receive tenofovir disoproxil fumarate treatment during late pregnancy had comparable long-term growth, renal function, and bone development up to 6-7 years after delivery. ? 2020 European Association for the Study of the Liver
|ISSN:||0168-8278||DOI:||10.1016/j.jhep.2020.01.021||SDG/Keyword:||alanine aminotransferase; alkaline phosphatase; calcium; hepatitis B surface antigen; hepatitis B vaccine; phosphorus; tenofovir disoproxil; antivirus agent; tenofovir; virus DNA; age; Article; body height; body weight; bone density; bone development; calcium blood level; child; child growth; controlled study; dual energy X ray absorptiometry; estimated glomerular filtration rate; female; fetus; follow up; hepatitis B; Hepatitis B virus; human; kidney function; lumbar spine; major clinical study; male; mother fetus relationship; phosphate blood level; prenatal exposure; priority journal; prospective study; sex; third trimester pregnancy; virus transmission; adult; blood; bone development; chronic hepatitis B; clinical trial; drug effect; genetics; glomerulus filtration rate; kidney; multicenter study; physiology; pregnancy; pregnancy complication; preschool child; prevention and control; vertical transmission; young adult; Adult; Antiviral Agents; Bone Development; Child; Child, Preschool; DNA, Viral; Female; Follow-Up Studies; Glomerular Filtration Rate; Hepatitis B virus; Hepatitis B, Chronic; Humans; Infectious Disease Transmission, Vertical; Kidney; Male; Pregnancy; Pregnancy Complications, Infectious; Prospective Studies; Tenofovir; Young Adult
|Appears in Collections:||醫學系|
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