Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy

Abstract

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.

Clinical trial registration: NCT00572273. http://www.clinicaltrials.gov/ct2/show/NCT00540605?term=mtn-002&rank=1.

Figures

Figure 1.

Maternal serum tenofovir concentration in nanograms per milliliter (y-axis, linear scale) versus hours after dosing (x-axis) curves are shown for all 16 women who participated in the study. Each woman is indicated with a different symbol (legend not shown). Only values above the limit of quantitation (0.3 ng/mL), except for predose values, are shown.