Coadministration of esomeprazole with fosamprenavir has no impact on steady-state plasma amprenavir pharmacokinetics

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Mark J SheltonGeoffrey Yuen

Abstract

To evaluate the drug interaction between fosamprenavir (FPV) and esomeprazole (ESO) after repeated doses in healthy adults. Subjects received ESO 20 mg once daily (qd) for 7 days followed by either ESO 20 mg qd + FPV 1400 mg twice daily (bid) or ESO 20 mg qd + FPV 700 mg bid + ritonavir (RTV) 100 mg bid for 14 days in arms 1 and 2, respectively. After a 21- to 28-day washout, subjects received either FPV 1400 mg bid for 14 days (arm 1) or FPV 700 mg bid + RTV 100 mg bid for 14 days (arm 2). Pharmacokinetic sampling was conducted on the last day of each treatment. Simultaneous coadministration of ESO 20 mg qd with either FPV 1400 mg bid or FPV 700 mg bid + RTV 100 mg bid had no effect on steady-state amprenavir pharmacokinetics. The only effect on plasma ESO exposure was a 55% increase in area under the plasma concentration-time curve during a dosing interval, tau[AUC0-tau], after coadministration of ESO 20 mg qd with FPV 1400 mg bid. FPV 1400 mg bid or FPV 700 mg bid + RTV 100 mg bid may be coadministered simultaneously with ESO without dose adjustment. However, the impact of staggered administration of proton pump inhibitors (PPI) on plasma amprenavir exposure is unknown at present.

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Citations

Feb 7, 2007·Antimicrobial Agents and Chemotherapy·Olanrewaju OkusanyaUNKNOWN ACTG 5043 Protocol Team
Dec 7, 2007·Antimicrobial Agents and Chemotherapy·Susan L FordMark J Shelton
Apr 29, 2008·Journal of Clinical Pharmacology·Cheri E KleinGeorge J Hanna
Jun 9, 2005·The Journal of Antimicrobial Chemotherapy·Alan Winston, Marta Boffito
Apr 13, 2007·Expert Opinion on Drug Metabolism & Toxicology·Sarah M McCabeGene D Morse
Jun 6, 2007·Expert Review of Anti-infective Therapy·Harrys A Torres, Roberto C Arduino
Nov 16, 2007·Expert Opinion on Pharmacotherapy·Sarah M RobertsonAlice Pau
Jan 16, 2008·Clinical Pharmacokinetics·Ronald W Falcon, Thomas N Kakuda
Jul 18, 2009·Expert Opinion on Drug Metabolism & Toxicology·Consuelo L Saccar
Jul 9, 2010·Clinical Pharmacokinetics·Ryuichi Ogawa, Hirotoshi Echizen

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