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AIDS Res Treat. 2012; 2012: 105980.
Published online Feb 20, 2012. doi:  10.1155/2012/105980
PMCID: PMC3290802
Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults
Mohammed Lamorde, 1 ,2 * Pauline Byakika-Kibwika, 1 ,2 ,3 William S. Tamale, 4 Francis Kiweewa, 4 Mairin Ryan, 2 Alieu Amara, 5 John Tjia, 5 David Back, 5 Saye Khoo, 5 Marta Boffito, 6 Cissy Kityo, 4 and Concepta Merry 1 ,2 ,3 ,7
1Infectious Diseases Institute, Makerere University, College of Health Sciences, P.O. Box 22418, Kampala, Uganda
2Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, St James's Hospital, Dublin 8, Ireland
3Infectious Diseases Network for Treatment and Research in Africa, Plot 537, Tufnell Drive, Mulago Hill, P.O. Box 70345, Kampala, Uganda
4Joint Clinical Research Centre, P.O. Box 10005, Kampala, Uganda
5Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L69 3GF, UK
6St Stephen's Centre, Chelsea and Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK
7Department of Genitourinary Medicine and Infectious Diseases, St James's Hospitals, Dublin 8, Ireland
*Mohammed Lamorde: mohalamorde/at/yahoo.co.uk
Academic Editor: Charles Chiedza Maponga
Received October 14, 2011; Accepted November 20, 2011.
Abstract
We investigated the effect of food on the steady-state pharmacokinetics of a proprietary fixed-dose combination (FDC) tablet containing tenofovir disoproxil fumarate (TDF)/emtricitabine/efavirenz. Fifteen Ugandan HIV-1 patients at steady-state dosing with TDF/emtricitabine/efavirenz were admitted for 24-hour intensive pharmacokinetic sampling after dosing in the fasting state. Blood sampling was repeated seven days later with TDF/emtricitabine/efavirenz administered with food (19 g fat). Drug concentrations in plasma were determined by liquid chromatography and tandem mass spectrometry. Geometric mean ratios (GMRs) and confidence intervals (CIs) of parameters were calculated (reference, fasting). For efavirenz, GMRs (90% CIs) for Cmax, AUC0−24, and C24 were 1.47 (1.24–1.75), 1.13 (1.03–1.23), and 1.01 (0.91–1.11), respectively. Corresponding GMRs were 1.04 (0.84–1.27), 1.19 (1.10–1.29), and 0.99 (0.82–1.19) for tenofovir, 0.83 (0.76–0.92), 0.87 (0.78–0.97), and 0.91 (0.73–1.14) for emtricitabine. Stable patients may take the FDC without meal restrictions. The FDC should be taken without food by patients experiencing central nervous system toxicities.
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