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Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women.

  • Author(s): Colbers, Angela
  • Best, Brookie
  • Schalkwijk, Stein
  • Wang, Jiajia
  • Stek, Alice
  • Hidalgo Tenorio, Carmen
  • Hawkins, David
  • Taylor, Graham
  • Kreitchmann, Regis
  • Burchett, Sandra
  • Haberl, Annette
  • Kabeya, Kabamba
  • van Kasteren, Marjo
  • Smith, Elizabeth
  • Capparelli, Edmund
  • Burger, David
  • Mirochnick, Mark
  • PANNA Network and the IMPAACT 1026 Study Team
  • et al.

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OBJECTIVE:To describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)-infected women during pregnancy and post partum. METHODS:HIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery. Cord blood samples and matching maternal blood samples were taken at delivery. The data were collected in 2 studies: P1026 (United States) and PANNA (Europe). Pharmacokinetic parameters were calculated. RESULTS:Eighteen women were included in the analysis. Most women (12; 67%) received 150 mg of maraviroc twice daily with a protease inhibitor, 2 (11%) received 300 mg twice daily without a protease inhibitor, and 4 (22%) had an alternative regimen. The geometric mean ratios for third-trimester versus postpartum maraviroc were 0.72 (90% confidence interval, .60-.88) for the area under the curve over a dosing interval (AUCtau) and 0.70 (0.58-0.85) for the maximum maraviroc concentration. Only 1 patient showed a trough concentration (Ctrough) below the suggested target of 50 ng/mL, both during pregnancy and post partum. The median ratio of maraviroc cord blood to maternal blood was 0.33 (range, 0.03-0.56). The viral load close to delivery was <50 copies/mL in 13 women (76%). All children were HIV negative at testing. CONCLUSIONS:Overall maraviroc exposure during pregnancy was decreased, with a reduction in AUCtau and maximum concentration of about 30%. Ctrough was reduced by 15% but exceeded the minimum Ctrough target concentration. Therefore, the standard adult dose seems sufficient in pregnancy. CLINICAL TRIALS REGISTRATION:NCT00825929 and NCT000422890.

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