par Colbers, Angela P H;Kabeya, Kabamba ;Van Der Ende, Marchina;Erasmus, M.;van der Ven, André J A M A.J.A.M.;Nellen, Jeannine F J B J.;Moltó, José;Nicastri, Emanuele;Giaquinto, Carlo;Gingelmaier, Andrea;Lyons, F.;Lambert, John;Wyen, Christoph;Faetkenheuer, Gerd;Rockstroh, Jürgen;Schwarze-Zander, Carolynne;Sadiq, Syed Tariq;Gilleece, Yvonne;Wood, Chris G A C.;Buschur, Shelley;Jackson, Chivon;Paul, Mary;Florez, Claudia;Bryan, Patricia;Stone, Monica;Katz, Mindy;Auguste, Raphaelle;Wiznia, Andrew;Bruder, Karen K.L.;Lewis, Gail;Casey, Denise;Losso, Marcelo;Ivalo, Silvina S.A.;Hakim, Alejandro;Deveikis, Audra;Batra, Jagmohan;Alvarez, Janielle Jackson;Knapp, Katherine K.M.;Sublette, Nina;Wride, Thomas;Febo, Irma I.L.;Santos, Ruth;Tamayo, Vivian; [et al.]
Référence Clinical infectious diseases, 61, 10, page (1582-1589)
Publication Publié, 2015-11
Référence Clinical infectious diseases, 61, 10, page (1582-1589)
Publication Publié, 2015-11
Article révisé par les pairs
Résumé : | 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. |