PMID- 27401570 OWN - NLM STAT- MEDLINE DCOM- 20170913 LR - 20201215 IS - 1098-6596 (Electronic) IS - 0066-4804 (Print) IS - 0066-4804 (Linking) VI - 60 IP - 9 DP - 2016 Sep TI - Detectable Tenofovir Levels in Breast-Feeding Infants of Mothers Exposed to Topical Tenofovir. PG - 5616-9 LID - 10.1128/AAC.00645-16 [doi] AB - 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. CI - Copyright (c) 2016, American Society for Microbiology. All Rights Reserved. FAU - Noguchi, Lisa M AU - Noguchi LM AD - Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA lnoguch1@jhu.edu. FAU - Montgomery, Elizabeth T AU - Montgomery ET AD - Women's Global Health Imperative, RTI International, San Francisco, California, USA. FAU - Biggio, Joseph R AU - Biggio JR AD - Department of Obstetrics and Gynecology, University of Alabama, Birmingham, Alabama, USA. FAU - Hendrix, Craig W AU - Hendrix CW AD - Department of Medicine (Clinical Pharmacology), Johns Hopkins University, Baltimore, Maryland, USA. FAU - Bogen, Debra L AU - Bogen DL AD - Department of Pediatrics, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. FAU - Hillier, Sharon L AU - Hillier SL AD - Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. FAU - Dai, James Y AU - Dai JY AD - Statistical Center for HIV/AIDS Research, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. FAU - Piper, Jeanna M AU - Piper JM AD - Division of AIDS/NIAID, U.S. National Institutes of Health, Bethesda, Maryland, USA. FAU - Marzinke, Mark A AU - Marzinke MA AD - Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. FAU - Dezzutti, Charlene S AU - Dezzutti CS AD - Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. FAU - Isaacs, S Karen AU - Isaacs SK AD - Science Facilitation, FHI 360, Durham, North Carolina, USA. FAU - Schwartz, Jill L AU - Schwartz JL AD - CONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA. FAU - Watts, D Heather AU - Watts DH AD - Maternal and Pediatric Infectious Disease Branch/NICHD/U.S. National Institutes of Health, Bethesda, Maryland, USA. FAU - Beigi, Richard H AU - Beigi RH AD - Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. LA - eng GR - UM1 AI069494/AI/NIAID NIH HHS/United States GR - UM1 AI068633/AI/NIAID NIH HHS/United States GR - P30 AI042855/AI/NIAID NIH HHS/United States GR - P30 CA015704/CA/NCI NIH HHS/United States GR - UM1 AI068615/AI/NIAID NIH HHS/United States GR - UM1 AI106707/AI/NIAID NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20160822 PL - United States TA - Antimicrob Agents Chemother JT - Antimicrobial agents and chemotherapy JID - 0315061 RN - 0 (Anti-HIV Agents) RN - 0 (Vaginal Creams, Foams, and Jellies) RN - 99YXE507IL (Tenofovir) SB - IM MH - Adult MH - Anti-HIV Agents/*blood MH - Breast Feeding MH - Female MH - HIV Infections/blood/drug therapy/metabolism MH - HIV-1/drug effects MH - Humans MH - Infant MH - Lactation/metabolism MH - Milk, Human/*metabolism MH - Mothers MH - Tenofovir/*blood/*pharmacokinetics/therapeutic use MH - Vaginal Creams, Foams, and Jellies/pharmacokinetics/therapeutic use MH - Young Adult PMC - PMC4997886 EDAT- 2016/07/13 06:00 MHDA- 2017/09/14 06:00 PMCR- 2017/03/01 CRDT- 2016/07/13 06:00 PHST- 2016/03/20 00:00 [received] PHST- 2016/06/26 00:00 [accepted] PHST- 2017/03/01 00:00 [pmc-release] PHST- 2016/07/13 06:00 [entrez] PHST- 2016/07/13 06:00 [pubmed] PHST- 2017/09/14 06:00 [medline] AID - AAC.00645-16 [pii] AID - 00645-16 [pii] AID - 10.1128/AAC.00645-16 [doi] PST - epublish SO - Antimicrob Agents Chemother. 2016 Aug 22;60(9):5616-9. doi: 10.1128/AAC.00645-16. Print 2016 Sep.