title: Detectable Tenofovir Levels in Breast-Feeding Infants of Mothers Exposed to Topical Tenofovir.
abstract: 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.
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA lnoguch1@jhu.edu.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Noguchi
authors.affiliation: Women's Global Health Imperative, RTI International, San Francisco, California, USA.
authors.forename: Elizabeth T
authors.initials: ET
authors.lastname: Montgomery
authors.affiliation: Department of Obstetrics and Gynecology, University of Alabama, Birmingham, Alabama, USA.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Biggio
authors.affiliation: Department of Medicine (Clinical Pharmacology), Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Craig W
authors.initials: CW
authors.lastname: Hendrix
authors.affiliation: Department of Pediatrics, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Debra L
authors.initials: DL
authors.lastname: Bogen
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hillier
authors.affiliation: Statistical Center for HIV/AIDS Research, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
authors.forename: James Y
authors.initials: JY
authors.lastname: Dai
authors.affiliation: Division of AIDS/NIAID, U.S. National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Jeanna M
authors.initials: JM
authors.lastname: Piper
authors.affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Marzinke
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Charlene S
authors.initials: CS
authors.lastname: Dezzutti
authors.affiliation: Science Facilitation, FHI 360, Durham, North Carolina, USA.
authors.forename: S Karen
authors.initials: SK
authors.lastname: Isaacs
authors.affiliation: CONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA.
authors.forename: Jill L
authors.initials: JL
authors.lastname: Schwartz
authors.affiliation: Maternal and Pediatric Infectious Disease Branch/NICHD/U.S. National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Richard H
authors.initials: RH
authors.lastname: Beigi
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000097:blood*; D001942:Breast Feeding; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy / Q000378:metabolism; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D007223:Infant; D007774:Lactation / Q000378:metabolism; D008895:Milk, Human / Q000378:metabolism*; D009035:Mothers; D000068698:Tenofovir / Q000097:blood* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D014622:Vaginal Creams, Foams, and Jellies / Q000493:pharmacokinetics / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D014622:Vaginal Creams, Foams, and Jellies; D000068698:Tenofovir