Steady-state pharmacokinetic and safety profiles of voriconazole and ritonavir in healthy male subjects

Antimicrobial Agents and Chemotherapy

Volumn 51, Issue 10, 2007, Pages 3617-3626

  Liu, Ping ^a   Foster, Grover ^a   Gandelman, Kuan ^a   LaBadie, Robert R ^a   Allison, Mark J ^b   Gutierrez, Maria J ^c   Sharma, Amarnath ^a  

^a PFIZER INC   (United States)

^b MDS Inc   (Canada)

^c Univ S Carolina Sch Med Vice P   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; PLACEBO; RITONAVIR; VORICONAZOLE;

ABNORMAL LABORATORY RESULT; ABNORMAL VISION; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG EXPOSURE; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; DRY EYE; DRY SKIN; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEADACHE; HEMATURIA; HOT FLUSH; HUMAN; INSOMNIA; LOW DRUG DOSE; MALE; PHOTOPHOBIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STEADY STATE; VIRUS INFECTION; VISUAL DISORDER;

ADULT; ANTI-HIV AGENTS; ANTIFUNGAL AGENTS; AREA UNDER CURVE; DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; PYRIMIDINES; RITONAVIR; SAMPLE SIZE; TRIAZOLES;

EID: 34948894967     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.00526-07     Document Type: Article

References (29)

1. Acosta, E. P., T. N. Kakuda, R. C. Brundage, P. L. Anderson, and C. V. Fletcher. 2000. Pharmacodynamics of human immunodeficiency virus type 1 protease inhibitors. Clin. Infect. Dis. 30(Suppl. 2):S151-S159.
2. Acosta, E. P., H. Wu, S. M. Hammer, S. Yu, D. R. Kuritzkes, A. Walawander, J. J. Eron, C. J. Fichtenbaum, C. Pettinelli, D. Neath, E. Ferguson, A. J. Saah, and J. G. Gerber. 2004. Comparison of two indinavir/ritonavir regimens in the treatment of HIV-infected individuals. J. Acquir. Immune Defic. Syndr. 37:1358-1366.
3. Boffito, M., D. Maitland, Y. Samarasinghe, and A. Pozniak. 2005. The pharmacokinetics of HIV protease inhibitor combinations. Curr. Opin. Infect. Dis. 18:1-7.
4. Cato, A., III, G. Cao, A. Hsu, J. Cavanaugh, J. Leonard, and R. Granneman. 1997. Evaluation of the effect of fluconazole on the pharmacokinetics of ritonavir. Drug Mctab. Dispos. 25:1104-1106.
5. Chi, J., A. L. Jayewardene, J. A. Stone, T. Motoya, and F. T. Aweeka. 2002. Simultaneous determination of five HIV protease inhibitors nelfinavir, indinavir, ritonavir, saquinavir and amprenavir in human plasma by LC/MS/MS. J. Pharm. Biomed Anal. 30:675-684.
6. Cooper, C. L., R. P. van Heeswijk, K. Gallicano, and D. W. Cameron. 2003. A review of low-dose ritonavir in protease inhibitor combination therapy. Clin. Infect. Dis. 36:1585-1592.
7. Cuenca-Estrella, M., J. L. Rodriguez-Tudela, E. Mellado, J. V. Martinez-Suarez, and A. Monzon. 1998. Comparison of the in-vitro activity of voriconazole (UK-109,496), itraconazole and amphotericin B against clinical isolates of Aspergillus fumigatus. J. Antimicrob Chemother. 42:531-533.
8. Espinel-Ingroff, A. 1998. In vitro activity of the new triazole voriconazole (UK-109,496) against opportunistic filamentous and dimorphic fungi and common and emerging yeast pathogens. J. Clin. Microbiol. 36:198-202.
9. Gass, R. J., J. Gal, P. W. Fogle, D. Detmar-Hanna, and J. G. Gerber. 1998. Neither dapsone hydroxylation nor Cortisol 6β-hydroxylation detects the inhibition of CYP3A4 by HIV-1 protease inhibitors. Eur. J. Clin. Pharmacol. 54:741-747.
10. Greenblatt, D. J., L. L. von Moltke, J. S. Harmatz, A. L. Durol, J. P. Daily, J. A. Graf, P. Mertzanis, J. L. Hoffman, and R. I. Shader. 2000. Alprazolam-ritonavir interaction: implications for product labeling. Clin. Pharmacol. Ther. 67:335-341.
11. Hoffman, H. L., and R. C. Rathbun. 2002. Review of the safety and efficacy of voriconazole. Exp. Opin. Investig. Drugs 11:409-429.
12. Hsu, A., G. R. Granneman, and R. J. Bertz. 1998. Ritonavir. Clinical pharmacokinetics and interactions with other anti-HIV agents. Clin. Pharmacokinet. 35:275-291.
13. Hyland, R., B. C. Jones, and D. A. Smith. 2003. Identification of the cytochrome P450 enzymes involved in the N-oxidation of voriconazole. Drug Metab. Dispos. 31:540-547.
14. Ikeda, Y., K. Umemura, K. Kondo, K. Sekiguchi, S. Miyoshi, and M. Nakashima. 2004. Pharmacokinetics of voriconazole and cytochrome P450 2C19 genetic status. Clin. Pharmacol. Ther. 75:587-588.
15. Kilby, J. M., A. Hill, and N. Buss. 2002. The effect of ritonavir on saquinavir plasma concentration is independent of ritonavir dosage: combined analysis of pharmacokinetic data from 97 subjects. HIV Med. 3:97-104.
16. Kupper, L., and K. Hafner. 1989. How appropriate are popular sample size formulas? Am. Statist. 43:101-105.
17. Luo, H. R., R. E. Poland, K. M. Lin, and Y. J. Wan. 2006. Genetic polymorphism of cytochrome P450 2C19 in Mexican Americans: a cross-ethnic comparative study. Clin. Pharmacol. Ther. 80:33-40.
18. Mikus, G., V. Schowel, M. Drzewinska, J. Rengelshausen, R. Ding, K. D. Riedel, J. Burhenne, J. Weiss, T. Thomsen, and W. E. Haefeli. 2006. Potent cytochrome P450 2C19 genotype-related interaction between voriconazole and the cytochrome P450 3A4 inhibitor ritonavir. Clin. Pharmacol. Ther. 80:126-135.
19. Ouellet, D., A. Hsu, G. R. Granneman, G. Carlson, J. Cavanaugh, H. Guenther, and J. M. Leonard. 1998. Pharmacokinetic interaction between ritonavir and clarithromycin. Clin. Pharmacol. Ther. 64:355-362.
20. Ouellet, D., A. Hsu, J. Qian, C. S. Locke, C. J. Eason, J. H. Cavanaugh, J. M. Leonard, and G. R. Granneman. 1998. Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers. Br. J. Clin. Pharmacol. 46:111-116.
21. Pfaller, M. A., J. Zhang, S. A. Messer, M. E. Brandt, R. A. Hajjeh, C. J. Jessup, M. Tumberland, E. K. Mbidde, and M. A. Ghannoum. 1999. In vitro activities of voriconazole, fluconazole, and itraconazole against 566 clinical isolates of Cryptococcus neoformans from the United States and Africa. Antimicrob. Agents Chemother. 43:169-171.
22. Purkins, L., N. Wood, P. Ghahramani, D. Kleinermans, G. Layton, and D. Nichols. 2003. No clinically significant effect of erythromycin or azithromycin on the pharmacokinetics of voriconazole in healthy male volunteers. Br. J. Clin. Pharmacol. 56(Suppl. 1):30-36.
23. Purkins, L., N. Wood, P. Ghahramani, E. R. Love, M. D. Eve, and A. Fielding. 2003. Coadministration of voriconazole and phenytoin: pharmacokinetic interaction, safety, and toleration. Br. J. Clin. Pharmacol. 56(Suppl. 1):37-44.
24. Purkins, L., N. Wood, D. Kleinermans, and D. Nichols. 2003. Voriconazole potentiates warfarin-induced prothrombin time prolongation. Br. J. Clin. Pharmacol. 56(Suppl. 1):24-29.
25. Stopher, D. A., and R. Gage. 1997. Determination of a new antifungal agent, voriconazole, by multidimensional high-performance liquid chromatography with direct plasma injection onto a size-exclusion column. J. Chromatogr. B 691:441-448.
26. Tan, K., N. Brayshaw, K. Tomaszewski, P. Troke, and N. Wood. 2006. Investigation of the potential relationships between plasma voriconazole concentrations and visual adverse events or liver function test abnormalities. J. Clin. Pharmacol. 46:235-243.
27. von Moltke, L. L., D. J. Greenblatt, J. M. Grassi, B. W. Granda, S. X. Duan, S. M. Fogelman, J. P. Daily, J. S. Harmatz, and R. I. Shader. 1998. Protease Inhibitors as inhibitors of human cytochromes P450: high risk associated with ritonavir. J. Clin. Pharmacol. 38:106-111.
28. Wood, N., K. Tan, L. Purkins, G. Layton, J. Hamlin, D. Kleinermans, and D. Nichols. 2003. Effect of omeprazole on the steady-state pharmacokinetics of voriconazole. Br. J. Clin. Pharmacol. 56(Suppl. 1):56-61.
29. Xie, H. G., C. M. Stein, R. B. Kim, G. R. Wilkinson, D. A. Flockhart, and A. J. Wood. 1999. Allelic, genotypic and phenotypic distributions of S-mephenytoin 4′-hydroxylase (CYP2C19) in healthy Caucasian populations of European descent throughout the world. Pharmacogenetics 9:539-549.