- 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.
© 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.