Craig Hendrix

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

Richard Beigi; Lisa Noguchi; Teresa Parsons; Ingrid Macio; Ratiya P Kunjara Na Ayudhya; Jianmeng Chen; Craig W Hendrix; Benoît Mâsse; Megan Valentine; Jeanna Piper; et al. (Profiled Authors: Craig Hendrix; Teresa Parsons)

Magee-Womens Hospital of the University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
The Journal of infectious diseases 2011;204(10):1527-31.

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.

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