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Clin Infect Dis. 2015 Nov 15;61(10):1582-9. doi: 10.1093/cid/civ587. Epub 2015 Jul 22.

Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women.

Author information

1
Department of Pharmacy.
2
UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences & School of Medicine, University of California San Diego.
3
Department of Pharmacy Department of Pharmacology and Toxicology, Radboud university medical center, Nijmegen.
4
Center for Biostatistics in AIDS Research, Harvard School of Public Health.
5
Maternal Child and Adolescent/Adult Center, University of Southern California School of Medicine, Los Angeles.
6
Department of Infectious Diseases, Hospital Universitario Virgen de las Nieves Granada, Spain.
7
Chelsea and Westminster Hospital.
8
Imperial College Healthcare NHS Trust, London, United Kingdom.
9
HIV/AIDS Research Department, Irmandade da Santa Casa de Misericordia de Porto Alegre, Brazil.
10
Boston Children's Hospital, Harvard Medical School.
11
Department of Infectious Diseases, Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany.
12
Department of Infectious Diseases, Saint-Pierre University Hospital, Brussels, Belgium.
13
Department of Internal Medicine, St Elisabeth Ziekenhuis, Tilburg, The Netherlands.
14
Maternal, Adolescent, and Pediatric Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
15
Boston University School of Medicine, Massachusetts.

Abstract

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.

KEYWORDS:

HIV; MTCT; maraviroc; pharmacokinetics; pregnancy

PMID:
26202768
PMCID:
PMC4614410
DOI:
10.1093/cid/civ587
[Indexed for MEDLINE]
Free PMC Article

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