Noguchi Lisa M, Montgomery Elizabeth T, Biggio Joseph R, Hendrix Craig W, Bogen Debra L, Hillier Sharon L, Dai James Y, Piper Jeanna M, Marzinke Mark A, Dezzutti Charlene S, Isaacs S Karen, Schwartz Jill L, Watts D Heather, Beigi Richard H
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
Women's Global Health Imperative, RTI International, San Francisco, California, USA.
Antimicrob Agents Chemother. 2016 Aug 22;60(9):5616-9. doi: 10.1128/AAC.00645-16. Print 2016 Sep.
Lactation studies are necessary evaluations of medications for reproductive-age women. We evaluated pharmacokinetics (PK), pharmacodynamics, safety, and adherence profiles associated with 7 days of 1% tenofovir (TFV) vaginal gel use during lactation. Tenofovir levels (maternal/infant serum, milk) and anti-HIV activity (milk), adverse events (AEs), and adherence were measured for 17 HIV-1-seronegative breast-feeding mother-infant pairs. Tenofovir use was well-tolerated and detected at low levels in maternal serum, milk, and infant serum but demonstrated no anti-HIV activity in milk.