Multiple-dose pharmacokinetic behavior of elvucitabine, a nucleoside reverse transcriptase inhibitor, administered over 21 days with lopinavir-ritonavir in human immunodeficiency virus type 1-infected subjects

Antimicrobial Agents and Chemotherapy

Volumn 53, Issue 2, 2009, Pages 662-669

  Colucci, Philippe ^a   Pottage, John C ^b   Robison, Heather ^b   Turgeon, Jacques ^a   Schürmann, Dirk ^c   Hoepelman, I M ^d   Ducharme, Murray P ^a,e  

^a UNIVERSITÉ DE MONTRÉAL   (Canada)

^b Achillion Pharmaceuticals   (United States)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^e Cetero Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ELVUCITABINE; LOPINAVIR PLUS RITONAVIR;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG HALF LIFE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; PRIORITY JOURNAL; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANTI-HIV AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; COHORT STUDIES; DRUG COMBINATIONS; HALF-LIFE; HIV INFECTIONS; HIV-1; HUMANS; MODELS, STATISTICAL; PYRIMIDINONES; REVERSE TRANSCRIPTASE INHIBITORS; RITONAVIR; ZALCITABINE;

EID: 59749101190     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00907-08     Document Type: Article

References (24)

1. Anderson, P. O., J. E. Knoben, and W. G. Troutman. 2002. Handbook of clinical drug data, 10th ed. McGraw-Hill, New York, NY.
2. Barry, M., et al. 1999. Pharmacokinetics and potential interactions amongst antiretroviral agents used to treat patients with HIV infection. Clin. Pharmacokinet. 36:289-304.
3. Collins, D., and A. Forrest. 1995. IT2S user's guide. State University of New York at Buffalo, Buffalo, NY.
4. Colucci, P., J. C. Pottage, H. Robison, J. Turgeon, and M. P. Ducharme. 2009. Effect of a single dose of ritonavir on the pharmacokinetic behavior of elvucitabine, a nucleoside reverse transcriptase inhibitor, administered in healthy volunteers. Antimicrob. Agents Chemother. 53:646-650.
5. D'Argenio, D., and A. Schumitzky. 1997. ADAPT II users manual. Biomedical Simulations Resource, University of Southern California-Los Angeles, CA.
6. d'Arminio Monforte, A., et al. 2000. Insights into the reasons for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naive patients. AIDS 14:499-507.
7. Drewe, J., et al. 1999. HIV protease inhibitor ritonavir: a more potent inhibitor of P-glycoprotein than the cyclosporine analog SDZ PSC 833. Biochem. Pharmacol. 57:1147-1152.
8. Dunkle, L. M., S. C. Oshana, Y.-C. Cheng, K. Hertogs, W. G. Rice, et al. 2001. ACH-126,443: a new nucleoside analog with potent activity against wild-type and resistant HIV-1 and a promising pharmacokinetic and mitochondrial safety profile, abstr. 303. In Abstr. Eighth Conf. Retrovir. Oppor. Infect., Chicago, IL, 4 to 8 February 2001.
9. Evans, W. E., and H. L. McLeod. 2003. Pharmacogenomics-drug disposition, drug targets, and side effects. N. Engl. J. Med. 348:538-549.
10. Fellay, J., et al. 2002. Response to antiretroviral treatment in HIV-1-infected individuals with allelic variants of the multidrug resistance transporter 1: a pharmacogenetics study. Lancet 359:30-36.
11. Fradette, C., et al. 2005. The utility of the population approach applied to bioequivalence in patients: comparison of 2 formulations of cyclosporine. Ther. Drug Monit. 27:592-600.
12. Gutmann, H., et al. 1999. Interactions of HIV protease inhibitors with ATP-dependent drug export proteins. Mol. Pharmacol. 56:383-389.
13. Hoffmeyer, S., et al. 2000. Functional polymorphisms of the human multidrug-resistance gene: multiple sequence variations and correlation of one allele with P-glycoprotein expression and activity in vivo. Proc. Natl. Acad. Sci. USA 97:3473-3478.
14. Kurata, Y., et al. 2002. Role of human MDR1 gene polymorphism in bioavailability and interaction of digoxin, a substrate of P-glycoprotein. Clin. Pharmacol. Ther. 72:209-219.
15. Noveroske, J., J. Mao, et al. 2006. A comparative bioavailability study of β-L-FD4C and 3TC each administered by intravenous injection and orally by tablet to beagle dogs, abstr. B020-666. Oread BioSafety, Inc., Farmington, CT.
16. Olson, D. P., et al. 2002. The protease inhibitor ritonavir inhibits the functional activity of the multidrug resistance related-protein 1 (MRP-1). AIDS 16:1743-1747.
17. Otto, M. J. 2004. New nucleoside reverse transcriptase inhibitors for the treatment of HIV infections. Curr. Opin. Pharmacol. 4:431-436.
18. Piscitelli, S. C., and K. D. Gallicano. 2001. Interactions among drugs for HIV and opportunistic infections. N. Engl. J. Med. 344:984-996.
19. Sakaeda, T., T. Nakamura, and K. Okumura. 2003. Pharmacogenetics of MDR1 and its impact on the pharmacokinetics and pharmacodynamics of drugs. Pharmacogenomics 4:397-410.
20. Schwab, M., M. Eichelbaum, and M. F. Fromm. 2003. Genetic polymorphisms of the human MDR1 drug transporter. Annu. Rev. Pharmacol. Toxicol. 43:285-307.
21. Sheldon, C., R. Sukovaty, and V. Andaloro. 2004. Validation of an LC-MS/ MS method for the quantitation of ACH-126,443 in human EDTA plasma, abstr. 27427-1. MDS Pharma Services, Lincoln, NE.
22. Stypinski, D., et al. 2004. Optimization of the therapeutic index of elvucitabine through PK/PD modeling. 5th Int. Workshop Clin. Pharmacol. HIV Ther., Rome, Italy.
23. Woodahl, E. L., et al. 2005. MDR1 G1199A polymorphism alters permeability of HIV protease inhibitors across P-glycoprotein-expressing epithelial cells. AIDS 19:1617-1625.
24. Wright, M. T. 2000. The old problem of adherence: research on treatment adherence and its relevance for HIV/AIDS. AIDS Care 12:703-710.