TY - JOUR
T1 - Exposure to latent tuberculosis treatment during pregnancy the PREVENT TB and the iadhere trials
AU - Moro, Ruth N.
AU - Scott, Nigel A.
AU - Vernon, Andrew
AU - Tepper, Naomi K.
AU - Goldberg, Stefan V.
AU - Schwartzman, Kevin
AU - Leung, Chi Chiu
AU - Schluger, Neil W.
AU - Belknap, Robert W.
AU - Chaisson, Richard E.
AU - Narita, Masahiro
AU - Machado, Elizabeth S.
AU - Lopez, Marta
AU - Sanchez, Jorge
AU - Villarino, Margarita E.
AU - Sterling, Timothy R.
N1 - Publisher Copyright:
Copyright © 2018 by the American Thoracic Society.
PY - 2018/5
Y1 - 2018/5
N2 - Rationale: Data are limited regarding the safety of 12-dose once-weekly isoniazid (H, 900 mg) plus rifapentine (P, 900 mg) (3HP) for latent infection treatment during pregnancy. Objectives: To assess safety and pregnancy outcomes among pregnant women who were inadvertently exposed to study medications in two latent tuberculosis infection trials (PREVENT TB or iAdhere) evaluating 3HP and 9 months of daily isoniazid (H, 300 mg) (9H). Methods: Data from reproductive-age (15-51 yr) women who received one or more study dose of 3HP or 9H in either trial were analyzed. Drug exposure during pregnancy occurred if the estimated date of conception was on or before the last dose date. Results: Of 126 pregnancies (125 participants) that occurred during treatment or follow-up, 87 were exposed to study drugs. Among these, fetal loss was reported for 4/31 (13%) and 8/56 (14%), 3HP and 9H, respectively (difference, 13% 2 14% = 21%; 95% confidence interval = 217% to 118%) and congenital anomalies in 0/20 and 2/41 (5%) live births, 3HP and 9H, respectively (difference, 0% 2 5% = 25%; 95% confidence interval = 218% to 116%). All fetal losses occurred in pregnancies of less than 20 weeks. Of the total 126 pregnancies, fetal loss was reported in 8/54 (15%) and 9/72 (13%), 3HP and 9H, respectively; and congenital anomalies in 1/37 (3%) and 2/56 (4%) live births, 3HP and 9H, respectively. The overall proportion of fetal loss (17/126 [13%]) and anomalies (3/93 [3%]) were similar to those estimated for the United States, 17% and 3%, respectively. Conclusions: Among reported pregnancies in these two latent tuberculosis infection trials, there was no unexpected fetal loss or congenital anomalies. These data offer some preliminary reassurance to clinicians and patients in circumstances when these drugs and regimens are the best option in pregnancy or in women of childbearing potential.
AB - Rationale: Data are limited regarding the safety of 12-dose once-weekly isoniazid (H, 900 mg) plus rifapentine (P, 900 mg) (3HP) for latent infection treatment during pregnancy. Objectives: To assess safety and pregnancy outcomes among pregnant women who were inadvertently exposed to study medications in two latent tuberculosis infection trials (PREVENT TB or iAdhere) evaluating 3HP and 9 months of daily isoniazid (H, 300 mg) (9H). Methods: Data from reproductive-age (15-51 yr) women who received one or more study dose of 3HP or 9H in either trial were analyzed. Drug exposure during pregnancy occurred if the estimated date of conception was on or before the last dose date. Results: Of 126 pregnancies (125 participants) that occurred during treatment or follow-up, 87 were exposed to study drugs. Among these, fetal loss was reported for 4/31 (13%) and 8/56 (14%), 3HP and 9H, respectively (difference, 13% 2 14% = 21%; 95% confidence interval = 217% to 118%) and congenital anomalies in 0/20 and 2/41 (5%) live births, 3HP and 9H, respectively (difference, 0% 2 5% = 25%; 95% confidence interval = 218% to 116%). All fetal losses occurred in pregnancies of less than 20 weeks. Of the total 126 pregnancies, fetal loss was reported in 8/54 (15%) and 9/72 (13%), 3HP and 9H, respectively; and congenital anomalies in 1/37 (3%) and 2/56 (4%) live births, 3HP and 9H, respectively. The overall proportion of fetal loss (17/126 [13%]) and anomalies (3/93 [3%]) were similar to those estimated for the United States, 17% and 3%, respectively. Conclusions: Among reported pregnancies in these two latent tuberculosis infection trials, there was no unexpected fetal loss or congenital anomalies. These data offer some preliminary reassurance to clinicians and patients in circumstances when these drugs and regimens are the best option in pregnancy or in women of childbearing potential.
KW - Latent tuberculosis infection treatment
KW - Pregnancy outcomes
KW - Safety assessment
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U2 - 10.1513/AnnalsATS.201704-326OC
DO - 10.1513/AnnalsATS.201704-326OC
M3 - Review article
C2 - 29393655
AN - SCOPUS:85046674982
SN - 2325-6621
VL - 15
SP - 570
EP - 580
JO - Annals of the American Thoracic Society
JF - Annals of the American Thoracic Society
IS - 5
ER -