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Skip Navigation LinksHome > March 13, 2013 - Volume 27 - Issue 5 > The pharmacokinetics, safety and efficacy of tenofovir and e...
AIDS:
doi: 10.1097/QAD.0b013e32835c208b
Clinical Science

The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women

Colbers, Angela P.H.a; Hawkins, David A.b; Gingelmaier, Andreac; Kabeya, Kabambad; Rockstroh, Jürgen K.e; Wyen, Christopherf; Weizsäcker, Katharinag; Sadiq, S. Tariqh; Ivanovic, Jelenai; Giaquinto, Carloj; Taylor, Graham P.k; Moltó, Josél; Burger, David M.a; on behalf of the PANNA network

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Abstract

Objective: To describe the pharmacokinetics of tenofovir and emtricitabine in the third trimester of pregnant HIV-infected women and at postpartum.

Design: A nonrandomized, open-label, multicentre phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe.

Methods: HIV-infected pregnant women treated with the nucleotide/nucleoside analogue reverse transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate (TDF 300 mg; equivalent to 245 mg tenofovir disoproxil) and/or emtricitabine (FTC 200 mg) were included in the study. Twenty-four-hour pharmacokinetic curves were recorded in the third trimester (preferably week 33) and postpartum (preferably week 4–6). Collection of a cord blood sample and maternal sample at delivery was optional. Pharmacokinetic parameters were calculated using WinNonlin software version 5.3. Statistical analysis was conducted using SPSS version 16.0.

Results: Thirty-four women were included in the analysis. Geometric mean ratios of third trimester vs. postpartum [90% confidence interval (CI)] were 0.77 (0.71–0.83) for TDF area under the curve (AUC0–24 h); 0.81 (0.68–0.96) for TDF Cmax and 0.79 (0.70–0.90) for TDF C24 h and 0.75 (0.68–0.82) for FTC AUC0–24 h; and 0.87 (0.77–0.99) for FTC Cmax and 0.77 (0.52–1.12) for FTC C24 h. The viral load close to delivery was less than 200 copies/ml in all but one patient, the average gestational age at delivery was 38 weeks. All children were tested HIV-negative and no congenital abnormalities were reported.

Conclusion: Although pharmacokinetic exposure of the NRTIs TDF and FTC during pregnancy is approximately 25% lower, this was not associated with virological failure in this study and did not result in mother-to-child transmission.

© 2013 Lippincott Williams & Wilkins, Inc.

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