Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up

We prospectively investigated the neurological development in infants born from mothers treated with telbivudine (LdT) in the third trimester for prevention of hepatitis B virus (HBV) mother-to-infant transmission. Mothers with high HBV load were assigned to either the LdT group (n = 81, 600 mg of L...

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Main Authors: Wei Yi, Xiuzhen Cao, Zhan Zeng, Weihua Cao, Ying Zhang, Fangfang Sun, Ying Wang, Gang Wan, Minghui Li, Yao Xie
Format: Article
Language:English
Published: Taylor & Francis Group 2021-12-01
Series:Virulence
Subjects:
Online Access:http://dx.doi.org/10.1080/21505594.2021.1936769
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author Wei Yi
Xiuzhen Cao
Zhan Zeng
Weihua Cao
Ying Zhang
Fangfang Sun
Ying Wang
Gang Wan
Minghui Li
Yao Xie
author_facet Wei Yi
Xiuzhen Cao
Zhan Zeng
Weihua Cao
Ying Zhang
Fangfang Sun
Ying Wang
Gang Wan
Minghui Li
Yao Xie
author_sort Wei Yi
collection DOAJ
description We prospectively investigated the neurological development in infants born from mothers treated with telbivudine (LdT) in the third trimester for prevention of hepatitis B virus (HBV) mother-to-infant transmission. Mothers with high HBV load were assigned to either the LdT group (n = 81, 600 mg of LdT each day from gestational week 28 to delivery) or the Control group (n = 39, untreated). Their infants were followed for 36 months to assess physical and neurological developments with Gesell Developmental Schedule tools. At 12 months after birth, the mean scores in the LdT group for gross motor, fine motor, adaptive, linguistic, and personal social domains were similar to those in the Control group. At 36 months, infants in the LdT group had higher mean scores for gross motor than the Control group (98.42 ± 9.69 vs. 94.54 ± 7.48, P = 0.03). In the LdT group, the rates of normal development were higher for gross motor (96.30% vs. 82.05% P = 0.01) and lower for adaptive (74.07% vs. 92.31% P = 0.02). Multivariate regression analyses showed that exposure to LdT during pregnancy was independently associated with infant’s development in gross motor (OR 6.49, 95% CI 1.37–30.20, P = 0.02) and adaptive (OR 0.18, 95% CI 0.05–0.71, P = 0.01) at 36 months. These results suggest that prenatal LdT exposure might affect neurological development in long-term observation. Abbreviations: LdT: telbivudine; HBV: hepatitis B virus; HBsAg: hepatitis B surface antigen; HBeAg: hepatitis Be antigen; HbsAb: hepatitis B surface antibody; ALT: alanine aminotransferase; NA: nucleoside/nucleotide analog; LAM: lamivudine; MTCT: mother-to-child transmission; GDS: Gesell Developmental Schedule; OR: odds ratio; CI: confidence interval; DQ: developmental quotient; RMB: renminbi; BMI: body mass Index; HBIG: hepatitis B immunoglobulin.
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spelling doaj.art-115d535d0943456a9da8b389c9b2ad182022-12-21T19:34:04ZengTaylor & Francis GroupVirulence2150-55942150-56082021-12-011211527153710.1080/21505594.2021.19367691936769Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-upWei Yi0Xiuzhen Cao1Zhan Zeng2Weihua Cao3Ying Zhang4Fangfang Sun5Ying Wang6Gang Wan7Minghui Li8Yao Xie9Beijing Ditan Hospital, Capital Medical UniversityBeijing Ditan Hospital, Capital Medical UniversityPeking University Ditan Teaching HospitalPeking University Ditan Teaching HospitalBeijing Ditan Hospital, Capital Medical UniversityBeijing Ditan Hospital, Capital Medical UniversityBeijing Children’s Hospital, Capital Medical UniversityBeijing Ditan Hospital, Capital Medical UniversityPeking University Ditan Teaching HospitalPeking University Ditan Teaching HospitalWe prospectively investigated the neurological development in infants born from mothers treated with telbivudine (LdT) in the third trimester for prevention of hepatitis B virus (HBV) mother-to-infant transmission. Mothers with high HBV load were assigned to either the LdT group (n = 81, 600 mg of LdT each day from gestational week 28 to delivery) or the Control group (n = 39, untreated). Their infants were followed for 36 months to assess physical and neurological developments with Gesell Developmental Schedule tools. At 12 months after birth, the mean scores in the LdT group for gross motor, fine motor, adaptive, linguistic, and personal social domains were similar to those in the Control group. At 36 months, infants in the LdT group had higher mean scores for gross motor than the Control group (98.42 ± 9.69 vs. 94.54 ± 7.48, P = 0.03). In the LdT group, the rates of normal development were higher for gross motor (96.30% vs. 82.05% P = 0.01) and lower for adaptive (74.07% vs. 92.31% P = 0.02). Multivariate regression analyses showed that exposure to LdT during pregnancy was independently associated with infant’s development in gross motor (OR 6.49, 95% CI 1.37–30.20, P = 0.02) and adaptive (OR 0.18, 95% CI 0.05–0.71, P = 0.01) at 36 months. These results suggest that prenatal LdT exposure might affect neurological development in long-term observation. Abbreviations: LdT: telbivudine; HBV: hepatitis B virus; HBsAg: hepatitis B surface antigen; HBeAg: hepatitis Be antigen; HbsAb: hepatitis B surface antibody; ALT: alanine aminotransferase; NA: nucleoside/nucleotide analog; LAM: lamivudine; MTCT: mother-to-child transmission; GDS: Gesell Developmental Schedule; OR: odds ratio; CI: confidence interval; DQ: developmental quotient; RMB: renminbi; BMI: body mass Index; HBIG: hepatitis B immunoglobulin.http://dx.doi.org/10.1080/21505594.2021.1936769neurological developmentchronic hepatitis bpregnancysafetytelbivudine
spellingShingle Wei Yi
Xiuzhen Cao
Zhan Zeng
Weihua Cao
Ying Zhang
Fangfang Sun
Ying Wang
Gang Wan
Minghui Li
Yao Xie
Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up
Virulence
neurological development
chronic hepatitis b
pregnancy
safety
telbivudine
title Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up
title_full Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up
title_fullStr Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up
title_full_unstemmed Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up
title_short Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up
title_sort developmental consequences of children born from mothers with telbivudine treatment during late pregnancy a prospective study with 3 year follow up
topic neurological development
chronic hepatitis b
pregnancy
safety
telbivudine
url http://dx.doi.org/10.1080/21505594.2021.1936769
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