Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults
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 fo...
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| Format: | Article |
| Language: | English |
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Wiley
2012-01-01
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| Series: | AIDS Research and Treatment |
| Online Access: | http://dx.doi.org/10.1155/2012/105980 |
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| author | Mohammed Lamorde Pauline Byakika-Kibwika William S. Tamale Francis Kiweewa Mairin Ryan Alieu Amara John Tjia David Back Saye Khoo Marta Boffito Cissy Kityo Concepta Merry |
| author_facet | Mohammed Lamorde Pauline Byakika-Kibwika William S. Tamale Francis Kiweewa Mairin Ryan Alieu Amara John Tjia David Back Saye Khoo Marta Boffito Cissy Kityo Concepta Merry |
| author_sort | Mohammed Lamorde |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-85d345423772495c99b653eb57252cfe |
| institution | Kabale University |
| issn | 2090-1240 2090-1259 |
| language | English |
| publishDate | 2012-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | AIDS Research and Treatment |
| spelling | doaj-art-85d345423772495c99b653eb57252cfe2025-02-03T01:12:25ZengWileyAIDS Research and Treatment2090-12402090-12592012-01-01201210.1155/2012/105980105980Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan AdultsMohammed Lamorde0Pauline Byakika-Kibwika1William S. Tamale2Francis Kiweewa3Mairin Ryan4Alieu Amara5John Tjia6David Back7Saye Khoo8Marta Boffito9Cissy Kityo10Concepta Merry11Infectious Diseases Institute, Makerere University, College of Health Sciences, P.O. Box 22418, Kampala, UgandaInfectious Diseases Institute, Makerere University, College of Health Sciences, P.O. Box 22418, Kampala, UgandaJoint Clinical Research Centre, P.O. Box 10005, Kampala, UgandaJoint Clinical Research Centre, P.O. Box 10005, Kampala, UgandaDepartment of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, St James's Hospital, Dublin 8, IrelandDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L69 3GF, UKDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L69 3GF, UKDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L69 3GF, UKDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L69 3GF, UKSt Stephen's Centre, Chelsea and Westminster Hospital, 369 Fulham Road, London SW10 9NH, UKJoint Clinical Research Centre, P.O. Box 10005, Kampala, UgandaInfectious Diseases Institute, Makerere University, College of Health Sciences, P.O. Box 22418, Kampala, UgandaWe 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.http://dx.doi.org/10.1155/2012/105980 |
| spellingShingle | Mohammed Lamorde Pauline Byakika-Kibwika William S. Tamale Francis Kiweewa Mairin Ryan Alieu Amara John Tjia David Back Saye Khoo Marta Boffito Cissy Kityo Concepta Merry Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults AIDS Research and Treatment |
| title | Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults |
| title_full | Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults |
| title_fullStr | Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults |
| title_full_unstemmed | Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults |
| title_short | Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults |
| title_sort | effect of food on the steady state pharmacokinetics of tenofovir and emtricitabine plus efavirenz in ugandan adults |
| url | http://dx.doi.org/10.1155/2012/105980 |
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