TY - JOUR
T1 - Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy
AU - Beigi, Richard
AU - Noguchi, Lisa
AU - Parsons, Teresa
AU - Macio, Ingrid
AU - Kunjara Na Ayudhya, Ratiya P.
AU - Chen, Jianmeng
AU - Hendrix, Craig W.
AU - Mâsse, Benoît
AU - Valentine, Megan
AU - Piper, Jeanna
AU - Watts, D. Heather
N1 - Funding Information:
Financial Support. This work was supported by the Division of AIDS, US National Institute of Allergy and Infectious Diseases, the US Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Mental Health, US National Institutes of Health (grant 1-U01-AI068633-0); and CONRAD (Arlington, Virginia). Potential conflicts of interest. All authors: No reported conflicts.
PY - 2011/11/15
Y1 - 2011/11/15
N2 - Tenofovir (TFV) 1% vaginal gel has been found to decrease sexual transmission of human immunodeficiency virus. To initiate investigations during pregnancy, 16 healthy pregnant women scheduled for cesarean delivery received a single application of TFV gel preoperatively. Maternal serum drug concentrations were determined and fetal cord blood, amniotic fluid, placental tissue, and endometrial tissue specimens were collected. The median maternal peak concentration and cord blood TFV concentrations were 4.3 and 1.9 ng/mL, respectively (∼100-and 40-fold lower than after TFV oral dosing, respectively). No adverse events were related to the use of TFV gel. These findings support ongoing and future investigations of TFV gel in pregnancy.
AB - Tenofovir (TFV) 1% vaginal gel has been found to decrease sexual transmission of human immunodeficiency virus. To initiate investigations during pregnancy, 16 healthy pregnant women scheduled for cesarean delivery received a single application of TFV gel preoperatively. Maternal serum drug concentrations were determined and fetal cord blood, amniotic fluid, placental tissue, and endometrial tissue specimens were collected. The median maternal peak concentration and cord blood TFV concentrations were 4.3 and 1.9 ng/mL, respectively (∼100-and 40-fold lower than after TFV oral dosing, respectively). No adverse events were related to the use of TFV gel. These findings support ongoing and future investigations of TFV gel in pregnancy.
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U2 - 10.1093/infdis/jir562
DO - 10.1093/infdis/jir562
M3 - Article
C2 - 21930612
AN - SCOPUS:80054773666
SN - 0022-1899
VL - 204
SP - 1527
EP - 1531
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 10
ER -