title: The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women.
abstract: OBJECTIVE
  To describe the pharmacokinetics of tenofovir and emtricitabine in the third trimester of pregnant HIV-infected women and at postpartum.
  
  
  METHODS
  A nonrandomized, open-label, multicentre phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe.
  
  
  METHODS
  HIV-infected pregnant women treated with the nucleotide/nucleoside analogue reverse transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate (TDF 300 mg; equivalent to 245 mg tenofovir disoproxil) and/or emtricitabine (FTC 200 mg) were included in the study. Twenty-four-hour pharmacokinetic curves were recorded in the third trimester (preferably week 33) and postpartum (preferably week 4-6). Collection of a cord blood sample and maternal sample at delivery was optional. Pharmacokinetic parameters were calculated using WinNonlin software version 5.3. Statistical analysis was conducted using SPSS version 16.0.
  
  
  RESULTS
  Thirty-four women were included in the analysis. Geometric mean ratios of third trimester vs. postpartum [90% confidence interval (CI)] were 0.77 (0.71-0.83) for TDF area under the curve (AUC0-24 h); 0.81 (0.68-0.96) for TDF Cmax and 0.79 (0.70-0.90) for TDF C24 h and 0.75 (0.68-0.82) for FTC AUC0-24 h; and 0.87 (0.77-0.99) for FTC Cmax and 0.77 (0.52-1.12) for FTC C24 h. The viral load close to delivery was less than 200  copies/ml in all but one patient, the average gestational age at delivery was 38 weeks. All children were tested HIV-negative and no congenital abnormalities were reported.
  
  
  CONCLUSIONS
  Although pharmacokinetic exposure of the NRTIs TDF and FTC during pregnancy is approximately 25% lower, this was not associated with virological failure in this study and did not result in mother-to-child transmission.
authors.affiliation: Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. a.colbers@akf.umcn.nl
authors.forename: Angela P H
authors.initials: AP
authors.lastname: Colbers
authors.forename: David A
authors.initials: DA
authors.lastname: Hawkins
authors.forename: Andrea
authors.initials: A
authors.lastname: Gingelmaier
authors.forename: Kabamba
authors.initials: K
authors.lastname: Kabeya
authors.forename: Jürgen K
authors.initials: JK
authors.lastname: Rockstroh
authors.forename: Christopher
authors.initials: C
authors.lastname: Wyen
authors.forename: Katharina
authors.initials: K
authors.lastname: Weizsäcker
authors.forename: S Tariq
authors.initials: ST
authors.lastname: Sadiq
authors.forename: Jelena
authors.initials: J
authors.lastname: Ivanovic
authors.forename: Carlo
authors.initials: C
authors.lastname: Giaquinto
authors.forename: Graham P
authors.initials: GP
authors.lastname: Taylor
authors.forename: José
authors.initials: J
authors.lastname: Moltó
authors.forename: David M
authors.initials: DM
authors.lastname: Burger
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000493:pharmacokinetics*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D000068679:Emtricitabine; D005060:Europe; D005260:Female; D005312:Fetal Blood; D015658:HIV Infections / Q000188:drug therapy / Q000378:metabolism* / Q000635:transmission; D015497:HIV-1; D006801:Humans; D018445:Infectious Disease Transmission, Vertical; D063065:Organophosphonates / Q000009:adverse effects / Q000493:pharmacokinetics*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000378:metabolism*; D011263:Pregnancy Trimester, Third; D000068698:Tenofovir; D019562:Viral Load; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine