Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women

PANNA Network and the IMPAACT 1026 Study Team

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1582-1589
Number of pages8
JournalClinical Infectious Diseases
Volume61
Issue number10
DOIs
StatePublished - Nov 15 2015

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HIV-1
Pregnant Women
Pharmacokinetics
Pregnancy
Third Pregnancy Trimester
HIV
Protease Inhibitors
Fetal Blood
Mothers
Critical Care
maraviroc
Viral Load
Postpartum Period
Area Under Curve
Clinical Trials
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. / PANNA Network and the IMPAACT 1026 Study Team.

In: Clinical Infectious Diseases, Vol. 61, No. 10, 15.11.2015, p. 1582-1589.

Research output: Contribution to journalArticle

PANNA Network and the IMPAACT 1026 Study Team 2015, 'Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women', Clinical Infectious Diseases, vol. 61, no. 10, pp. 1582-1589. https://doi.org/10.1093/cid/civ587
PANNA Network and the IMPAACT 1026 Study Team. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. Clinical Infectious Diseases. 2015 Nov 15;61(10):1582-1589. https://doi.org/10.1093/cid/civ587
PANNA Network and the IMPAACT 1026 Study Team. / Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. In: Clinical Infectious Diseases. 2015 ; Vol. 61, No. 10. pp. 1582-1589.
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title = "Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women",
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.",
author = "{PANNA Network and the IMPAACT 1026 Study Team} and Angela Colbers and Brookie Best and Stein Schalkwijk and Jiajia Wang and Alice Stek and {Hidalgo Tenorio}, Carmen and David Hawkins and Graham Taylor and Regis Kreitchmann and Sandra Burchett and Annette Haberl and Kabamba Kabeya and {Van Kasteren}, Marjo and Elizabeth Smith and Edmund Capparelli and David Burger and Mark Mirochnick and {Van Der Ende}, {M. E.} and M. Erasmus and {Van Der Ven}, {A. J.A.M.} and J. Nellen and J. Molt{\'o} and E. Nicastri and C. Giaquinto and A. Gingelmaier and F. Lyons and J. Lambert and C. Wyen and G. Faetkenheuer and Rockstroh, {J. K.} and C. Schwarze-Zander and Sadiq, {S. Tariq} and Y. Gilleece and C. Wood and Shelley Buschur and Chivon Jackson and Mary Paul and Claudia Florez and Patricia Bryan and Monica Stone and Mindy Katz and Raphaelle Auguste and Andrew Wiznia and Bruder, {Karen L.} and Gail Lewis and Denise Casey and Losso, {Marcelo H.} and Ivalo, {Silvina A.} and Alejandro Hakim and Nina Sublette",
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T1 - Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women

AU - PANNA Network and the IMPAACT 1026 Study Team

AU - Colbers, Angela

AU - Best, Brookie

AU - Schalkwijk, Stein

AU - Wang, Jiajia

AU - Stek, Alice

AU - Hidalgo Tenorio, Carmen

AU - Hawkins, David

AU - Taylor, Graham

AU - Kreitchmann, Regis

AU - Burchett, Sandra

AU - Haberl, Annette

AU - Kabeya, Kabamba

AU - Van Kasteren, Marjo

AU - Smith, Elizabeth

AU - Capparelli, Edmund

AU - Burger, David

AU - Mirochnick, Mark

AU - Van Der Ende, M. E.

AU - Erasmus, M.

AU - Van Der Ven, A. J.A.M.

AU - Nellen, J.

AU - Moltó, J.

AU - Nicastri, E.

AU - Giaquinto, C.

AU - Gingelmaier, A.

AU - Lyons, F.

AU - Lambert, J.

AU - Wyen, C.

AU - Faetkenheuer, G.

AU - Rockstroh, J. K.

AU - Schwarze-Zander, C.

AU - Sadiq, S. Tariq

AU - Gilleece, Y.

AU - Wood, C.

AU - Buschur, Shelley

AU - Jackson, Chivon

AU - Paul, Mary

AU - Florez, Claudia

AU - Bryan, Patricia

AU - Stone, Monica

AU - Katz, Mindy

AU - Auguste, Raphaelle

AU - Wiznia, Andrew

AU - Bruder, Karen L.

AU - Lewis, Gail

AU - Casey, Denise

AU - Losso, Marcelo H.

AU - Ivalo, Silvina A.

AU - Hakim, Alejandro

AU - Sublette, Nina

PY - 2015/11/15

Y1 - 2015/11/15

N2 - 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.

AB - 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.

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DO - 10.1093/cid/civ587

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JO - Clinical Infectious Diseases

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SN - 1058-4838

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