- Colbers, Angela;
- Best, Brookie;
- Schalkwijk, Stein;
- Wang, Jiajia;
- Stek, Alice;
- Tenorio, Carmen Hidalgo;
- Hawkins, David;
- Taylor, Graham;
- Kreitchmann, Regis;
- Burchett, Sandra;
- Haberl, Annette;
- Kabeya, Kabamba;
- van Kasteren, Marjo;
- Smith, Elizabeth;
- Capparelli, Edmund;
- Burger, David;
- Mirochnick, Mark;
- Team, for the PANNA Network and the IMPAACT 1026 Study;
- van der Ende, ME;
- Erasmus, MC;
- 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, S Tariq;
- Gilleece, Y;
- Wood, C;
- Buschur, Shelley;
- Jackson, Chivon;
- Paul, Mary;
- Florez, Claudia;
- Bryan, Patricia;
- Stone, Monica;
- Katz, Mindy;
- Auguste, Raphaelle;
- Wiznia, Andrew;
- Bruder, Karen L;
- Lewis, Gail;
- Casey, Denise;
- Losso, Marcelo H;
- Ivalo, Silvina A;
- Hakim, Alejandro;
- Deveikis, Audra;
- Batra, Jagmohan;
- Alvarez, Janielle Jackson;
- Knapp, Katherine M;
- Sublette, Nina;
- Wride, Thomas;
- Febo, Irma L;
- Santos, Ruth;
- Tamayo, Vivian
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.