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Original article

Atazanavir exposure is effective during pregnancy regardless of tenofovir use

Angela Colbers, David Hawkins, Carmen Hidalgo-Tenorio, Marchina van der Ende, Andrea Gingelmaier, Katharina Weizsäcker, Kabamba Kabeya, Graham Taylor, Jürgen Rockstroh, John Lambert, José Moltó, Christoph Wyen, S Tariq Sadiq, Jelena Ivanovic, Carlo Giaquinto, David Burger, the PANNA network

Corresponding author name: Angela Colbers
Corresponding author e-mail: angela.colbers@radboudumc.nl

Citation: Antiviral Therapy 2015; 20:57-64
doi: 10.3851/IMP2820

Date accepted: 17 June 2014
Date published online: 03 July 2014

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 AUC0-24h, 0.70 (0.61, 0.80) for Cmax and 0.59 (0.48, 0.72) for C24h. 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.
ClinicalTrials.gov number NCT00825929.

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