Colbers, Angela, Hawkins, David, Hidalgo-Tenorio, Carmen, van der Ende, Marchina, Gingelmaier, Andrea, Weizsaecker, Katharina, Kabeya, Kabamba, Taylor, Graham, Rockstroh, Juergen, Lambert, John, Molto, Jose ORCID: 0000-0003-4564-1963, Wyen, Christoph, Sadiq, S. Tariq, Ivanovic, Jelena, Giaquinto, Carlo and Burger, David (2015). Atazanavir exposure is effective during pregnancy regardless of tenofovir use. Antivir. Ther., 20 (1). S. 57 - 65. LONDON: INT MEDICAL PRESS LTD. ISSN 1359-6535

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Abstract

Background: We studied the effect of pregnancy on atazanavir pharmacokinetics in the presence and absence of tenofovir. Methods: This was a non-randomized, open-label, multicentre Phase IV study in HIV-infected pregnant women recruited from European HIV treatment centres. HIV-infected pregnant women treated with boosted atazanavir (300/100 mg or 400/100 mg atazanavir/ritonavir) as part of their combination antiretroviral therapy (cART) were included in the study. 24 h pharmacokinetic curves were recorded in the third trimester and postpartum. Collection of a cord blood and maternal sample at delivery was optional. Results: 31 patients were included in the analysis, 21/31 patients used tenofovir as part of cART. Median (range) gestational age at delivery was 39 weeks (36-42). Approaching delivery 81% (25 patients) had an HIV viral load < 50 copies/ml, all < 1,000 copies/ml. Least squares means ratios (90% CI) of atazanavir pharmacokinetic parameters third trimester/postpartum were: 0.66 (0.57, 0.75) for AUC(0-24h), 0.70 (0.61, 0.80) for C-max and 0.59 (0.48, 0.72) for C-24h. No statistical difference in pharmacokinetic parameters was found between patients using tenofovir versus no tenofovir. None of the patients showed atazanavir concentrations < 0.15 mg/l (target for treatment-naive patients). One baby had a congenital abnormality, which was not likely to be related to atazanavir/ritonavir use. None of the children were HIV-infected. Conclusions: Despite 34% lower atazanavir exposure during pregnancy, atazanavir/ritonavir 300/100 mg once daily generates effective concentrations for protease inhibitor (PI)-naive patients, even if co-administered with tenofovir. For treatment-experienced patients (with relevant PI resistance mutations) therapeutic drug monitoring of atazanavir should be considered to adapt the atazanavir/ritonavir dose on an individual basis.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Colbers, AngelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hawkins, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hidalgo-Tenorio, CarmenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van der Ende, MarchinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gingelmaier, AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weizsaecker, KatharinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kabeya, KabambaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Taylor, GrahamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rockstroh, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lambert, JohnUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Molto, JoseUNSPECIFIEDorcid.org/0000-0003-4564-1963UNSPECIFIED
Wyen, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sadiq, S. TariqUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ivanovic, JelenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Giaquinto, CarloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burger, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-416136
DOI: 10.3851/IMP2820
Journal or Publication Title: Antivir. Ther.
Volume: 20
Number: 1
Page Range: S. 57 - 65
Date: 2015
Publisher: INT MEDICAL PRESS LTD
Place of Publication: LONDON
ISSN: 1359-6535
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ANTIRETROVIRAL DRUGS; UNITED-STATES; PHARMACOKINETICS; RITONAVIR; PHARMACOLOGY; PROGRAM; PLASMAMultiple languages
Infectious Diseases; Pharmacology & Pharmacy; VirologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/41613

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