1. Long-term growth and bone development in children of HBV-infected mothers with and without fetal exposure to tenofovir disoproxil fumarate
- Author
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C. P. Chen, Y. H. Lin, H. H. Lin, Hong-Yuan Hsu, J. J. Hu, K. C. Chang, Y. K. Chang, T. H. Su, Y. C. Chiu, C. K. Yang, Wan-Hsin Wen, M. S. Tsai, H. Y. Chiueh, H. L. Hwa, D. S. Chen, Huey-Ling Chen, F. S. Peng, Ming-Kwang Shyu, Lu Lu Zhao, L. H. Lin, C. L. Lee, Shu Chi Mu, K. H. Chao, P. J. Cheng, K. H. Chen, Ming Wei Lai, Y. C. Lin, C. L. Hsieh, S. M. Chen, J. C. Shih, T. H. Wang, C. C. Lin, W. R. Yang, B. H. Lau, P. Y. Lin, J. P. Huang, Mei-Hwei Chang, Jia-Feng Wu, C. Y. Yeung, H. S. Pan, Tiffany Ting-Fang Shih, J. J. Hsu, C. J. Liu, B. Q. She, Y. L. Chang, H. J. Chen, Yen-Hsuan Ni, L. M. Lo, Y. N. Su, Yi-Ching Tung, S. W. Cheng, and Chien-Nan Lee
- Subjects
Adult ,Male ,0301 basic medicine ,Hepatitis B virus ,medicine.medical_specialty ,Bone development ,Renal function ,Kidney ,medicine.disease_cause ,Antiviral Agents ,Serology ,Young Adult ,03 medical and health sciences ,Hepatitis B, Chronic ,0302 clinical medicine ,Pregnancy ,Internal medicine ,medicine ,Humans ,Prospective Studies ,Pregnancy Complications, Infectious ,Child ,Tenofovir ,Bone mineral ,Bone Development ,Hepatology ,business.industry ,medicine.disease ,Infectious Disease Transmission, Vertical ,Clinical trial ,030104 developmental biology ,Child, Preschool ,DNA, Viral ,Alkaline phosphatase ,Female ,030211 gastroenterology & hepatology ,business ,Follow-Up Studies ,Glomerular Filtration Rate - 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.
- Published
- 2020
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