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    Therapeutic drug monitoring of lopinavir/ritonavir in pregnancy.

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    Authors
    Lambert, J S
    Else, L J
    Jackson, V
    Breiden, J
    Gibbons, S
    Dickinson, L
    Back, D J
    Brennan, M
    Connor, E O
    Boyle, N
    Fleming, C
    Coulter-Smith, S
    Khoo, S H
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    Affiliation
    The Rotunda Hospital, Dublin, Ireland.
    Issue Date
    2011-03
    MeSH
    Adult
    Anti-HIV Agents
    Chromatography, High Pressure Liquid
    Drug Monitoring
    Female
    HIV Infections
    HIV-1
    Humans
    Pregnancy
    Pregnancy Complications, Infectious
    Pyrimidinones
    Ritonavir
    Young Adult
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    Citation
    Therapeutic drug monitoring of lopinavir/ritonavir in pregnancy. 2011, 12 (3):166-73 HIV Med.
    Journal
    HIV medicine
    URI
    http://hdl.handle.net/10147/144282
    DOI
    10.1111/j.1468-1293.2010.00865.x
    PubMed ID
    20726906
    Additional Links
    http://onlinelibrary.wiley.com/doi/10.1111/j.1468-1293.2010.00865.x/abstract;jsessionid=405F26BBACE83E92C33F86A8726513BF.d01t02?systemMessage=Wiley+Online+Library+will+be+disrupted+8+Oct+from+10-14+BST+for+monthly+maintenance
    Abstract
    The aim of the study was to determine total and unbound lopinavir (LPV) plasma concentrations in HIV-infected pregnant women receiving lopinavir/ritonavir (LPV/r tablet) undergoing therapeutic drug monitoring (TDM) during pregnancy and postpartum.
    Women were enrolled in the study who were receiving the LPV/r tablet as part of their routine prenatal care. Demographic and clinical data were collected and LPV plasma (total) and ultrafiltrate (unbound) concentrations were determined in the first, second and third trimesters using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Postpartum sampling was performed where applicable. Antepartum and postpartum trough concentrations (C(trough) ) were compared independently [using analysis of variance (anova)] and on a longitudinal basis (using a paired t-test).
    Forty-six women were enrolled in the study (38 Black African). Forty women initiated LPV/r treatment in pregnancy. Median (range) gestation at initiation was 25 (15-36) weeks and median (range) baseline CD4 count and viral load were 346 (14-836) cells/μL and 8724 (<50-267408) HIV-1 RNA copies/mL, respectively. Forty women (87%) had LPV concentrations above the accepted minimum effective concentration for wild-type virus (MEC; 1000 ng/mL). Geometric mean (95% confidence interval [CI]) total LPV concentrations in the first/second [3525 (2823-4227) ng/mL; n=16] and third [3346 (2813-3880) ng/mL; n=43] trimesters were significantly lower relative to postpartum [5136 (3693-6579) ng/mL; n=12] (P=0.006). In a paired analysis (n=12), LPV concentrations were reduced in the third trimester [3657 (2851-4463) ng/mL] vs. postpartum (P=0.021). No significant differences were observed in the LPV fraction unbound (fu%). Conclusions The above target concentrations achieved in the majority of women and similarities in the fu% suggest standard dosing of the LPV/r tablet is appropriate during pregnancy. However, reduced LPV concentrations in the second/third trimesters and potentially compromised adherence highlight the need for TDM-guided dose adjustment in certain cases.
    Item Type
    Article
    Language
    en
    ISSN
    1468-1293
    ae974a485f413a2113503eed53cd6c53
    10.1111/j.1468-1293.2010.00865.x
    Scopus Count
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    Rotunda Hospital

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