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Antimicrobial Agents and Chemotherapy, February 2005, p. 680-684, Vol. 49, No. 2
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.2.680-684.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Pharmacokinetic Study of Tenofovir Disoproxil Fumarate Combined with Rifampin in Healthy Volunteers

J. A. H. Droste,1,2* C. P. W. G. M. Verweij-van Wissen,1,2 B. P. Kearney,3 R. Buffels,3 P. J. vanHorssen,4 Y. A. Hekster,1,2 and D. M. Burger1,2

Department of Clinical Pharmacy, University Medical Centre Nijmegen,1 Nijmegen University Centre for Infectious Diseases,2 Farma Research B.V., Nijmegen, The Netherlands,4 Gilead Sciences, Foster City, California3

Received 1 July 2004/ Returned for modification 23 August 2004/ Accepted 6 October 2004

Tenofovir disoproxil fumarate (tenofovir DF) was studied in combination with rifampin in 24 healthy subjects in a multiple-dose, open-label, single-group, two-period study. All subjects were given tenofovir DF at 300 mg once a day (QD) from days 1 to 10 (period 1). From days 11 to 20 the subjects received tenofovir DF at 300 mg combined with rifampin at 600 mg QD (period 2). The multiple-dose pharmacokinetics of tenofovir (day 10 and 20) and rifampin (day 20) were assessed. The drug-related adverse events (AEs) experienced during this study were mostly mild. Only one grade 3 AE possibly or probably related to the treatment (raised liver enzyme levels) occurred during period 2; the subject was withdrawn from the study. Pharmacokinetic data for 23 subjects were thus evaluable. Point estimates for the mean ratios of tenofovir with rifampin versus tenofovir alone for the area under the concentration-time curve from time zero to 24 h (AUC0-24), the maximum concentration of drug in plasma (Cmax), and the minimum concentration of drug in plasma (Cmin) were 0.88, 0.84, and 0.85, respectively. The 90% classical confidence intervals for AUC0-24, Cmax, and Cmin were 0.84 to 0.92, 0.78 to 0.90, and 0.80 to 0.91, respectively, thus suggesting pharmacokinetic equivalence. Similarly, coadministration of rifampin and tenofovir DF did not result in changes in the values of the tenofovir pharmacokinetic parameters. For rifampin, the values of the pharmacokinetic parameters found in this study were comparable to those found in the literature, indicating that tenofovir DF has no effect on the pharmacokinetics of rifampin. In conclusion, adaptation of either the rifampin or the tenofovir DF dose for the simultaneous treatment of tuberculosis and human immunodeficiency virus (HIV) infection in HIV-infected patients is probably not required.

* Corresponding author. Mailing address: Department of Clinical Pharmacy, University Medical Centre Nijmegen, P.O. Box 9101, 533 KF, 6500 HB Nijmegen, The Netherlands. Phone: 31-24-3616405. Fax: 31-24-3540331. E-mail: J.Droste{at}akf.umcn.nl.

Antimicrobial Agents and Chemotherapy, February 2005, p. 680-684, Vol. 49, No. 2
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.2.680-684.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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