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

PLASMA CONCENTRATIONS OF EFAVIRENZ (EFV) IN PREGNANT HIV-INFECTED WOMEN TREATED WITH EFV CONTAINING REGIMEN

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePe3.2C12

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

INTRODUCTION: EFV is not recommended during pregnancy for teratogenic effects in animal and no PK data are available on EFV exposed HIV-infected pregnant women. However, some HIV-infected women have been exposed to EFV during pregnancy for different reasons: continuation of previous treatment lost of follow-up, differed diagnostic of pregnancy, unknown pregnancy status, etc. The aim of our study was to determine trough plasma concentrations (C_min) of EFV in pregnant HIV-infected women.

METHODS: Observational and single center study, conducted from 2000 to 2004, including pregnant women receiving an EFV containing regimen. EFV C_min were measured using HPLC-UV detection (LOQ=10 ng/mL) and interpreted according to a therapeutic range of 1100 to 4000 ng/ml.

RESULTS: Sixteen pregnant HIV-infected women were enrolled, receiving EFV (600 mg QD) and a backbone of ZDV-3TC (n=6), 3TC-ddI (n=3) and 3TC-d4T (n=1), ZDV-ddI (n=1), d4T-ddI (n=1), ddI-TDF (n=1), d4T-3TC-LPV/r (n=1), ZDV-ddI-LPV/r (n=1), d4T-ddI-3TC-NFV-SQV (n=1). Seven patients received EFV during all pregnancy duration, 7 during the first trimester, one during the first two and one during the latest two trimesters. Median (range, n) EFV C_min was 2,253 ng/ml (<10 – 12,003; 28) in 12 pregnant women. No difference was found between trimesters. Twenty-one EFV C_min were in the predefined therapeutic range, one >4,000 ng/mL and 3 < LOQ suggesting adherence difficulties. Patients had median (range) CD4 cell count 311/mm³ (87 – 1912). All pregnant HIV-infected women had plasma HIV-RNA <200 c/mL at delivery. The different combinations of antiretroviral drugs were well tolerated during pregnancy.

CONCLUSIONS: In our study, 75% of EFV C_min were in the therapeutic range suggesting minor or no PK modifications of EFV during pregnancy. Even if EFV containing regimens are not recommended during pregnancy, the safety and the antiretroviral efficacy were good during pregnancy and at delivery in mothers and newborns.

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050724
Clinical | WePe3.2C12 | Bruno Cassard
Pharmacological monitoring of ARV therapy

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