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Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women

  • Author(s): Colbers, A
  • Best, B
  • Schalkwijk, S
  • Wang, J
  • Stek, A
  • Hidalgo Tenorio, C
  • Hawkins, D
  • Taylor, G
  • Kreitchmann, R
  • Burchett, S
  • Haberl, A
  • Kabeya, K
  • Van Kasteren, M
  • Smith, E
  • Capparelli, E
  • Burger, D
  • Mirochnick, M
  • Van Der Ende, ME
  • Erasmus, M
  • Van Der Ven, AJAM
  • Nellen, J
  • Moltó, J
  • Nicastri, E
  • Giaquinto, C
  • Gingelmaier, A
  • Lyons, F
  • Lambert, J
  • Wyen, C
  • Faetkenheuer, G
  • Rockstroh, JK
  • Schwarze-Zander, C
  • Sadiq, ST
  • Gilleece, Y
  • Wood, C
  • Buschur, S
  • Jackson, C
  • Paul, M
  • Florez, C
  • Bryan, P
  • Stone, M
  • Katz, M
  • Auguste, R
  • Wiznia, A
  • Bruder, KL
  • Lewis, G
  • Casey, D
  • Losso, MH
  • Ivalo, SA
  • Hakim, A
  • Deveikis, A
  • Batra, J
  • Alvarez, JJ
  • Knapp, KM
  • Sublette, N
  • Wride, T
  • Febo, IL
  • Santos, R
  • Tamayo, V
  • et al.

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© The Author 2015. Published by Oxford University Press on behalf of the Infectious. 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 AUCtauand maximum concentration of about 30%. Ctroughwas reduced by 15% but exceeded the minimum Ctroughtarget concentration. Therefore, the standard adult dose seems sufficient in pregnancy. Clinical Trials Registration.NCT00825929 and NCT000422890.

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