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Systemic and Renal Pharmacokinetics of Adefovir and Tenofovir Upon Coadministration

From Gilead Sciences Inc, Foster City, California. Informed consent was obtained from all subjects. This study was performed in compliance with current good clinical practice and was conducted under the review of the MDS Pharma Services Institutional Review Board, whose operations are in compliance with Section 56 of Title 21 of the Code of Federal Regulations. Financial support for this study was provided by Gilead Sciences Inc. The results of this study were presented in part at the 11th Conference of Retrovirus and Opportunistic Infections (CROI) (February 8-11, 2004, San Francisco, California) and was presented at the 15th International AIDS Conference (July 11-16, 2004, Bangkok, Thailand).

Adefovir and tenofovir are nucleotide analogs that undergo renal secretion by the human renal organic anion transporter. The pharmacokinetics of tenofovir and adefovir following the administration of tenofovir disoproxil fumarate and adefovir dipivoxil alone and together were determined in 24 healthy subjects in an 8-day, open-label, fixed-sequence study. Subjects received oral doses of adefovir dipivoxil on days 1 and 8 and oral doses of tenofovir disoproxil fumarate on days 2 to 8. Pharmacokinetic sampling was performed on days 1, 7, and 8. The plasma pharmacokinetics of tenofovir and adefovir were unaltered upon coadministration. Furthermore, the renal clearances (CL_renal) of tenofovir and adefovir were unaffected by their coadministration. The plasma C_max values of tenofovir and adefovir were 33-fold and 340-fold lower than their K_m values for the human renal organic anion transporter. These results demonstrate that coadministration of tenofovir disoproxil fumarate and adefovir dipivoxil does not result in substantial changes to their individual pharmacokinetic profiles.

Key Words: Tenofovir • adefovir • pharmacokinetics • drug interaction • hOAT1

Address for reprints: Srinivasan Ramanathan, PhD, Gilead Sciences Inc, 333 Lakeside Drive, Foster City, CA 94404.

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