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266
Long-Term Safety of Fetal Exposure to Tenofovir
in Infants from Hepatitis B Mothers
Calvin Q. Pan1, Zhongping Duan2, Er Hei Dai3, Guo-Rong
Han4, Shu Qing Zhang5, Yuming Wang6, Huai Hong Zhang7,
Bao Shen Zhu8, Suwen Li8, Hong-Xiu Jiang4, Yi Ding4, Wen
Jing Zhao9, Shi Lian Li10, Xiao Hu Zhang7 and Huai Bin Zou2,
(1)Division of Gastroenterology and Hepatology, New York
University Langone Health, (2)Artificial Liver Center, Beijing
Youan Hospital, (3)The Fifth Hospital of Shijiazhuang, (4)
Department of Gynecology and Obstetrics, The Second
Affiliated Hospital of the Southeast University, (5)Department
of Artificial Liver, Hepatobiliary Disease Hospital of Ji Lin
Province, (6)Institute for Infectious Diseases, Southwest
Hospital, Army Medical University, (7)Department of Medicine,
Nanyang Center Hospital, (8)Department of Gynecology and
Obstetrics, The Fifth Hospital of Shijiazhuang, (9)Central
Laboratory, Hepatobiliary Disease Hospital of Ji Lin Province,
(10)Institute for Infectious Diseases, Southwest Hospital
Background: Randomized-trial data on the long-term effects
on infants’ physical growth and neurodevelopment of the use
of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B
(CHB) mothers are lacking. Methods: All 180 infants who
completed the IN-US174-0174 study were offered participation
in a long- term follow-up (LTFU) study.1 They were from CHB
mothers who were randomly assigned (1:1 ratio) to receive
usual care without antiviral therapy or to receive TDF from
30 to 32 weeks of gestation until postpartum week 4. For
the LTFU study, infants were assessed at the ages of 72,
120 and 192 weeks for growth and neurodevelopment with
Bayley-III measurement. Their bone mineral density (BMD)
was measured at week 192. The neurodevelopmental delay
was defined by cognitive and language composite scores
<85 (1 SD below the mean of 100).2 These parameters
were compared between the TDF-exposed and TDFunexposed
groups. Results: Among 180 infants completed
in the initial study, 176 (98%) participated in the LTFU study
and 144 (82%) completed the LTFU. In the TDF-exposed
group, the mean (±SD) duration of fetal exposure to TDF
was 8.57±0.53 weeks. The gestational age, delivery mode,
weight, height, and Apgar score at birth were similar in the
two groups. At week 192, there was no significant difference
in the pre-specified outcomes between groups including head
circumference, height, BMD, cognitive, social-emotional
and adaptive behavior measurements between groups.
There was no neurodevelopmental delay in the cohort. In the
TDF-exposed group, children had significantly higher motorcomposite
scores (146.46±6.39 vs 142.88±9.54; p=0.009) and
boys had significantly lower mean body weight (18.48±2.35kg
vs 19.84±3.46kg; p= 0.029). However, the boys’ mean body
weight in the TDF-exposed group was significantly higher
than that of the national Chinese reference value of 4-year-old
boys (18.48±2.35kg vs 16.64±1.89; p=0.010).3Conclusion:
Among infants with fetal exposure to TDF, the physical
growth, BMD, and neurodevelopment were similar to those
without the exposure and within the normal range of Chinese
reference values during 192-week follow-up. Our data support
the safety of using TDF during the third trimester in mothers
with CHB. Acknowledgment: (Funded by Gilead Sciences;
ClinicalTrials.gov number, NCT01488526.) References: Pan
CQ, Duan Z, Dai E, et al. Tenofovir to Prevent Hepatitis B
Transmission in Mothers with High Viral Load. N Engl J Med
2016;374:2324-34. Johnson S, Moore T, Marlow N. Using the
Bayley-III to assess neurodevelopmental delay: which cut-off
should be used? Pediatr Res 2014;75:670-4. Li H. [Growth
standardized values and curves based on weight, length/
height and head circumference for Chinese children under 7
years of age]. Zhonghua Er Ke Za Zhi 2009;47:173-8.
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发表于 2018-10-9 21:29
由吉利德科学资助;