3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

THERAPEUTIC DRUG MONITORING OF LOPINAVIR/RITONAVIR (LPV/R) CONTAINING REGIMEN IN PREGNANT HIV-INFECTED WOMEN

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePe3.2C09

Cassard B., Rouault A., Damond F., Pattyn A., Batallan A., Legac S., Peytavin G., Matheron S.
Hospital Bichat-Claude Bernard, Paris, France

INTRODUCTION: Low pharmacokinetic exposure of LPV has been described in pregnant HIV-infected women. To avoid virological failure or HIV vertical transmission, last French guidelines advised to determine plasma antiretroviral drugs concentrations during the third trimester of pregnancy. The aim of our study was to determine trough plasma concentrations (C_min) of LPV in pregnant HIV-infected women.

METHODS: Observational single center study, conducted from 2001 to 2004, including pregnant women receiving a LPV/r containing regimen. C_min LPV were determined mainly during the third trimester of pregnancy, using HPLC-UV detection (LOQ = 30 mg/mL) and interprepreted according to the therapeutic range of 3,000 to 7,000 ng/ml. Plasma HIV-1 RNA and CD4 cell count were measured at delivery.

RESULTS: Sixteen pregnant HIV-infected women were enrolled, receiving LPV/r and a backbone of ZDV-3TC (n=9), ZDV-ABC (n=2), 3TC-ddI (n=1), ABC-ddI (n=1), ABC-TDF (n=1), ZDV-ddI (n=1) and ZDV-ddI-EFV (n=1). LPV/r BID doses were 400/100 mg (n=13), 400/200 mg (n=2) and 266/66 mg (n=1). Median (range,n) LPV C_min 4,011 ng/ml (<30 – 9,300; 27) in pregnant HIV-infected women. Sixteen LPV C_min were in the predefined therapeutic range. Ten LPV C_min were <3000 ng/ml, two LPV C_min < LOQ suggesting adherence difficulties in one patient and one >7,000 ng/mL. During pregnancy, 3 dose adjustments have been applied according to LPV C_min: from 266/66 to 400/100, from 400/100 to 400/200 and from 400/100 to 533/133 mg BID. Safety was good. At delivery, 75% had plasma HIV RNA <50 c/mL and the others were included in 165 to 368 c/mL. Median (range) CD4 count was 402/mm³ (67 – 700).

CONCLUSIONS: This study confirms the suboptimal LPV C_min during pregnancy. Therapeutic drug monitoring could be useful to optimise efficacy of LPV/r containing regimen.

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050724
Clinical | WePe3.2C09 | Bruno Cassard
Pharmacological Monitoring of ARV Therapy

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