Back, DJ

Breiden, J

Brennan, M

Coulter-Smith, S

Else, LJ

Jackson, V

Khoo, SH

Lambert, J

Weldridge, C

English

PubMed

LJ Else

V Jackson

M Brennan

J Breiden

C Weldridge

S Coulter-Smith

DJ Back

SH Khoo

J Lambert

Springer - Publisher Connector

Therapeutic drug monitoring (TDM) of atazanavir in pregnancy

POSTER PRESENTATION Open Access
Therapeutic drug monitoring (TDM) of atazanavir
in pregnancy
LJ Else1*, V Jackson2, M Brennan2, J Breiden3, C Weldridge3, S Coulter-Smith2, DJ Back1, SH Khoo1, J Lambert4
From Tenth International Congress on Drug Therapy in HIV Infection
Glasgow, UK. 7-11 November 2010
Background
Pregnant women experience physiological changes dur-
ing pregnancy resulting in clinically significant altera-
tions in antiretroviral pharmacokinetics (PK). Therefore,
achieving and maintaining optimal plasma concentra-
tions of antiretroviral drugs is essential for maternal
health and minimising the risk of mother-to-child trans-
mission of HIV.
Purpose of the study
To describe atazanavir/ritonavir (ATV/r) PK during
pregnancy.
Methods
In this prospective, open labelled study, pregnant HIV-
positive women received ATV/r as part of their routine
pre-natal care. Demographic and clinical data were col-
lected, and ATV plasma concentrations [ATV] were
determined in the first (T1) and/or second (T2) and/or
third (T3) trimester using HPLC-MS/MS (LLQ = 0.05
µg/mL). Postpartum (PP) sampling was performed where
applicable. Antepartum (AP) and PP PK parameters were
compared using a One-way ANOVA (for independent
data sets) and a paired t-test (for paired data).
Summary of results
From January 2007 31 women (25 black African) were
enrolled in the study. All received ATV/r at standard
dose of 1 tablet once daily (300/100 mg od). 10/31
women initiated ATV/r treatment during pregnancy.
Median (range) gestation at initiation in these patients
was 24 weeks (7-35). Median (range) baseline CD4
count was 393 cells/µL (153-869) and 17 patients had a
baseline plasma viral load of < 50 copies/mL. [ATV]
were determined in 10/31 (T1); 17/31 (T2); 27/31 (T3)
and 21/31 (PP) patients. Time of TDM sampling and
[ATV] (geometric mean; 95%CI) are given in the Table.
2/17 patients at T2, 2/27 (T3) and 2/21 at PP had con-
centrations <LLQ (suggesting non-adherence). [ATV]
were lower AP relative to that observed at PP (Table 1).
Equally, in a paired analysis of 17 patients (T3 vs. PP),
[ATV] were significantly reduced at T3 (P=0.0005).
Conclusions
Although ATV concentrations were reduced in the third
trimester, standard ATV/r dosing did achieve therapeu-
tic levels (>150 ng/mL) both antepartum and postpar-
tum, suggesting the current regimen is appropriate in
pregnancy.
1University of Liverpool, Department of Pharmacology, Liverpool, UK
Full list of author information is available at the end of the article
Table 1
T1 (n=10) T2 (n=17) T3 (n=27) PP (n=21) P value
[ATV], µg/mL 1.03 (0.49-2.53) 0.75 (0.59-1.45) 0.66 (0.63-1.03) 1.17 (1.09-1.81) 0.06
CV, % 108 84 59 55 -
Time of sampling, h 14.6 (12.5-17.5) 18.0 (16-21.8) 19.0 (17.6-21.9) 19.1 (17.4-22.3) 0.102
Else et al. Journal of the International AIDS Society 2010, 13(Suppl 4):P177
http://www.jiasociety.org/content/13/S4/P177
© 2010 Else et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Author details
1University of Liverpool, Department of Pharmacology, Liverpool, UK. 2The
Rotunda Hospital, Dublin, Ireland. 3Mater Misericordiae University Hospital,
The Catherine McAuley Research Centre, Dublin, Ireland. 4University College
Dublin, Dublin, Ireland.
Published: 8 November 2010
doi:10.1186/1758-2652-13-S4-P177
Cite this article as: Else et al.: Therapeutic drug monitoring (TDM) of
atazanavir in pregnancy. Journal of the International AIDS Society 2010 13
(Suppl 4):P177.
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Else et al. Journal of the International AIDS Society 2010, 13(Suppl 4):P177
http://www.jiasociety.org/content/13/S4/P177
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Therapeutic drug monitoring (TDM) of atazanavir in pregnancy

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