Long-term growth and bone development in children of HBV-infected mothers with and without fetal exposure to tenofovir disoproxil fumarate
Journal
Journal of Hepatology
Journal Volume
72
Journal Issue
6
Pages
1082-1087
Date Issued
2020
Author(s)
Wen W.-H.
Zhao L.-L.
Lai M.-W.
Mu S.-C.
Su Y.N.
Chen S.M.
Lin C.C.
Lin P.Y.
Yang W.R.
Hu J.J.
Yang C.K.
Chang Y.K.
Chen K.H.
Lin H.H.
Lin Y.H.
Chen H.J.
Pan H.S.
Lau B.H.
Lee C.L.
Cheng P.J.
Chang Y.L.
Chiueh H.Y.
Wang T.H.
Hsu J.J.
Lo L.M.
Hsieh C.L.
Cheng S.W.
Tsai M.S.
Lin L.H.
She B.Q.
Peng F.S.
Lin Y.C.
Chen C.P.
Huang J.P.
Yeung C.Y.
Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study)
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
Other Subjects
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
Publisher
Elsevier B.V.
Type
journal article