Impact of sex on the pharmacokinetics and pharmacodynamics of 1% tenofovir gel

Betsy Herold, Beatrice A. Chen, Robert A. Salata, Mark A. Marzinke, Clifton W. Kelly, Charlene S. Dezzutti, Ian Mcgowan, Beth Galaska, Lisa Levy, Jeanna M. Piper, Sharon Hillier, Craig W. Hendrix

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background. Tenofovir (TFV) gel partially protected against human immunodeficiency virus (HIV) in one but not subsequent trials. The disappointing results were attributed largely to poor adherence. However, timing of gel application relative to sex may impact pharmacokinetics and contribute to outcomes. Thus, we conducted a single-dose pharmacokinetic study of TFV gel applied 1 or 24 hours before or 1 hour before and 1 hour after (BAT) sex and compared results with dosing without sex. Methods. Twenty-four couples were enrolled; cervicovaginal lavage (CVL) and tissue were collected 2 hours after sex with matching timed collections at no sex visits and assayed for drug concentrations and CVL anti-HIV activity. Results. Compared with dosing without sex, median TFV concentrations after sex decreased 72% and 78% (P

Original languageEnglish (US)
Pages (from-to)375-382
Number of pages8
JournalClinical Infectious Diseases
Volume62
Issue number3
DOIs
StatePublished - Feb 1 2016

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Tenofovir
Pharmacokinetics
Gels
Therapeutic Irrigation
HIV

Keywords

  • HIV
  • MTN-011
  • pharmacokinetics
  • post-coital
  • tenofovir gel

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

Cite this

Herold, B., Chen, B. A., Salata, R. A., Marzinke, M. A., Kelly, C. W., Dezzutti, C. S., ... Hendrix, C. W. (2016). Impact of sex on the pharmacokinetics and pharmacodynamics of 1% tenofovir gel. Clinical Infectious Diseases, 62(3), 375-382. https://doi.org/10.1093/cid/civ913

Impact of sex on the pharmacokinetics and pharmacodynamics of 1% tenofovir gel. / Herold, Betsy; Chen, Beatrice A.; Salata, Robert A.; Marzinke, Mark A.; Kelly, Clifton W.; Dezzutti, Charlene S.; Mcgowan, Ian; Galaska, Beth; Levy, Lisa; Piper, Jeanna M.; Hillier, Sharon; Hendrix, Craig W.

In: Clinical Infectious Diseases, Vol. 62, No. 3, 01.02.2016, p. 375-382.

Research output: Contribution to journalArticle

Herold, B, Chen, BA, Salata, RA, Marzinke, MA, Kelly, CW, Dezzutti, CS, Mcgowan, I, Galaska, B, Levy, L, Piper, JM, Hillier, S & Hendrix, CW 2016, 'Impact of sex on the pharmacokinetics and pharmacodynamics of 1% tenofovir gel', Clinical Infectious Diseases, vol. 62, no. 3, pp. 375-382. https://doi.org/10.1093/cid/civ913
Herold, Betsy ; Chen, Beatrice A. ; Salata, Robert A. ; Marzinke, Mark A. ; Kelly, Clifton W. ; Dezzutti, Charlene S. ; Mcgowan, Ian ; Galaska, Beth ; Levy, Lisa ; Piper, Jeanna M. ; Hillier, Sharon ; Hendrix, Craig W. / Impact of sex on the pharmacokinetics and pharmacodynamics of 1% tenofovir gel. In: Clinical Infectious Diseases. 2016 ; Vol. 62, No. 3. pp. 375-382.
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