TY - JOUR
T1 - Drug exposure to infants born to mothers taking Elexacaftor, Tezacaftor, and Ivacaftor
AU - Collins, Bethany
AU - Fortner, Christopher
AU - Cotey, Amanda
AU - Esther, Charles R.
AU - Trimble, Aaron
N1 - Funding Information:
Dr. Esther reports from the National Institutes of Health ( NIH/NIEHS P30-ES10126 , NIH/NHLBI P30-DK065988 and P01 HL108808 ), and Cystic Fibrosis Foundation ( RDP R026-CR11 ). Dr. Trimble reports funding from the Cystic Fibrosis Foundation ( TRIMBL19AC0 ).
Funding Information:
These findings underscore the need for additional data on effects of HEMT use with pregnancy, particularly in a prospective, multi-centered fashion, as well as provide proof-of-concept for pharmacokinetic studies of modulators in pregnancy. The Maternal and Fetal Outcomes in the Era of Modulators (MAYFLOWERS) study sponsored by the CF Foundation and CF Therapeutics Development Network is currently starting, which we hope will provide more robust results to better assist clinical providers and patients prepare for and manage pregnancy in CF.The authors would like to thank the mothers and their families for allowing access to these samples during major life events. Also, we would like to thank the local hospitals and clinic which helped facilitate sample collection. Dr. Esther reports from the National Institutes of Health (NIH/NIEHS P30-ES10126,NIH/NHLBI P30-DK065988 and P01 HL108808), and Cystic Fibrosis Foundation (RDP R026-CR11). Dr. Trimble reports funding from the Cystic Fibrosis Foundation (TRIMBL19AC0).
Publisher Copyright:
© 2022 European Cystic Fibrosis Society
PY - 2022/7
Y1 - 2022/7
N2 - Elexacaftor, tezacaftor, ivacaftor (ETI) have been associated with marked clinical improvements in adults with CF, which appears to be associated with increased fertility. However, maternal and fetal effects of therapy continued during pregnancy are not well understood. We collected maternal blood, infant blood, cord blood, and breast milk from 3 mother-infant pairs from women who elected to remain on ETI therapy while pregnant. Our results demonstrated relatively high levels of ETI in cord blood, suggesting placental transfer of these compounds, as well as low levels of ETI in breast milk and infant blood, suggesting further transfer of these compounds to breast-fed infants in the postnatal period. These data underscore the need for larger studies on the effects of modulator surrounding reproduction.
AB - Elexacaftor, tezacaftor, ivacaftor (ETI) have been associated with marked clinical improvements in adults with CF, which appears to be associated with increased fertility. However, maternal and fetal effects of therapy continued during pregnancy are not well understood. We collected maternal blood, infant blood, cord blood, and breast milk from 3 mother-infant pairs from women who elected to remain on ETI therapy while pregnant. Our results demonstrated relatively high levels of ETI in cord blood, suggesting placental transfer of these compounds, as well as low levels of ETI in breast milk and infant blood, suggesting further transfer of these compounds to breast-fed infants in the postnatal period. These data underscore the need for larger studies on the effects of modulator surrounding reproduction.
KW - Breast milk
KW - Elexacaftor
KW - Ivacaftor
KW - Pregnancy
KW - Tezacaftor
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U2 - 10.1016/j.jcf.2021.12.004
DO - 10.1016/j.jcf.2021.12.004
M3 - Article
C2 - 34952795
AN - SCOPUS:85121740464
SN - 1569-1993
VL - 21
SP - 725
EP - 727
JO - Journal of Cystic Fibrosis
JF - Journal of Cystic Fibrosis
IS - 4
ER -