Long-term growth and bone development in children of HBV-infected mothers with and without fetal exposure to tenofovir disoproxil fumarate

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. Children participating in a prospective, multisite trial o...

Full description

Saved in:
Bibliographic Details
Published in:Journal of hepatology 2020-06, Vol.72 (6), p.1082-1087
Main Authors: Wen, Wan-Hsin, Chen, Huey-Ling, Shih, Tiffany Ting-Fang, Wu, Jia-Feng, Ni, Yen-Hsuan, Lee, Chien-Nan, Zhao, Lu-Lu, Lai, Ming-Wei, Mu, Shu-Chi, Tung, Yi-Ching, Hsu, Hong-Yuan, Chang, Mei-Hwei, Shyu, M.K., Hwa, H.L., Su, Y.N., Shih, J.C., Chao, K.H., Chiu, Y.C., Chang, K.C., Liu, C.J., Su, T.H., Chen, D.S., 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.
Format: Article
Language:English
Subjects:
Age
Alkaline phosphatase
Antiviral therapy
Bone (long)
Bone growth
Bone mineral density
Calcium
Calcium (blood)
Children
Fetuses
Glomerular filtration rate
Maternal transmission
Mother-to-infant transmission
Perinatal transmission
Phosphorus
Pregnancy
Renal function
Serology
Tenofovir
Vertical transmission
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. 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. 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). 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. NCT01312012 (ClinicalTrials.gov) 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. [Display omitted] •Short-term TDF use during pregnancy to prevent maternal HBV transmission is safe.•Children with and without fetal exposure to TDF have comparable long-term growth.•Children's renal function and bone development are unaffected.
ISSN:0168-8278
1600-0641
DOI:10.1016/j.jhep.2020.01.021