Population pharmacokinetics of ganciclovir in solid-organ transplant recipients receiving oral valganciclovir

Antimicrobial Agents and Chemotherapy

Volumn 53, Issue 7, 2009, Pages 3017-3023

  Perrottet, N ^a   Csajka, C ^a   Pascual, M ^a   Manuel, O ^a   Lamoth, F ^a   Meylan, P ^a   Aubert, J D ^a   Venetz, J P ^a   Soccal, P ^b   Decosterd, L A ^a   Biollaz, J ^a   Buclin, T ^a  

^a LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^b UNIVERSITY HOSPITAL   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

GANCICLOVIR; VALGANCICLOVIR;

ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; COMPARTMENT MODEL; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; GENDER; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NEUTROPENIA; NONLINEAR MIXED EFFECT MODEL; ORGAN TRANSPLANTATION; PRIORITY JOURNAL; PROPHYLAXIS; SKIN TOXICITY; STATISTICAL MODEL; THROMBOCYTOPENIA; VOMITING;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; FEMALE; GANCICLOVIR; GLOMERULAR FILTRATION RATE; HUMANS; MALE; MIDDLE AGED; ORGAN TRANSPLANTATION; VIREMIA; YOUNG ADULT;

EID: 67649966286     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00836-08     Document Type: Article

References (34)

1. Armendariz, Y., A. Caldes, H. Colom, S. Gilvernet, C. Peraire, J. Domenech, J. M. Grinyò, J. J. Wilkins, and M. O. Karlsson. 2006. Abstr. 15th PAGE Meet., abstr. 1012. http://www.page-meeting.org/?abstract=1012.
2. Åsberg, A., A. Humar, H. Rollag, A. G. Jardine, H. Mouas, M. D. Pescovitz, D. Sgarabotto, M. Tuncer, I. L. Noronha, and A. Hartmann, on behalf of the VICTOR study group. 2007. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am. J. Transplant. 7:2106-2113.
3. Beal, S. L., L. B. Sheiner, and A. J. Boeckmann (ed.). 1989-2006. NONMEM user guides. Icon Development Solutions, Ellicott City, MD.
4. Cockroft, D. W., and M. H. Gault. 1976. Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41.
5. Cvetković, R. S., and K. Wellington. 2005. Valganciclovir: a review of its use in the management of CMV infection and disease in immunocompromised patients. Drugs 65:859-878.
6. Czock, D., C. Scholle, F. M. Rasche, D. Schaarschmidt, and F. Keller. 2002. Pharmacokinetics of valganciclovir and ganciclovir in renal impairment. Clin. Pharmacol. Ther. 72:142-150.
7. Estrada-Zambarano, A., C. Biosca-Adzet, B. Bayés-Genís, M. Dolade-Botias, R. Lauruzica-Valmemoros, and R. Romero-González. 2007. Evaluation of equations to estimate the glomerular filtration rate in kidney transplant recipients. Transplant. Proc. 39:2210-2213.
8. Fishman, J. A., and R. H. Rubin. 1998. Infection in organ-transplant recipients. N. Engl. J. Med. 338:1741-1751.
9. Groves, C. E., W. B. Suhre, N. J. Cherrington, and S. H. Wright. 2006. Sex differences in the mRNA, protein, and functional expression of organic anion transporter (Oat) 1, Oat3, and organic cation transporter (Oct) 2 in rabbit renal proximal tubules. J. Pharmacol. Exp. Ther. 316:742-752.
10. Jung, D., and A. Dorr. 1999. Single-dose pharmacokinetics of valganciclovir in HIV- and CMV-seropositive subjects. J. Clin. Pharmacol. 39:800-804.
11. Jung, D., M. H. AbdelHameed, J. Hunter, P. Teitelbaum, A. Dorr, and K. Griffy. 1999. The pharmacokinetics and safety profile of oral ganciclovir in combination with trimethoprim in HIV- and CMV-seropositive patients. Br. J. Clin. Pharmacol. 47:255-259.
12. Karlsson, M. O., and L. B. Sheiner. 1993. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J. Pharmacokinet. Biopharm. 21:735-750.
13. Klein, I. H. H. T., A. Abrahams, T. van Ede, R. J. Hené, H. A. Koomans, and G. Ligtenberg. 2002. Different effects of tacrolimus and cyclosporine on renal hemodynamics and blood pressure in healthy subjects. Transplantation 73:732-736.
14. Lee, W., and R. B. Kim. 2004. Transporters and renal drug elimination. Annu. Rev. Pharmacol. Toxicol. 44:137-166.
15. Levey, A. S., J. Coresh, T. Greene, J. Marsh, L. A. Stevens, J. W. Kusek, and F. Van Lente, for the chronic kidney disease epidemiology collaboration. 2007. Expressing the modification of diet in renal disease study for estimating glomerular filtration rate with standardized serum creatinine values. Clin. Chem. 53:766-772.
16. Limaye, A. P., L. Corey, D. M. Koelle, C. L. Davis, and M. Boeckh. 2000. Emergence of ganciclovir-resistant cytomegalovirus disease among recipients of solid organ transplants. Lancet 356:645-649.
17. Ljubojevic, M., C. M. Herak-Kramberger, Y. Hagos, A. Bahn, H. Endou, G. Burckhardt, and I. Sabolic. 2004. Rat renal cortical OAT1 and OAT3 exhibit gender differences determined by both androgen stimulation and estrogen inhibition. 2004. Am. J. Physiol. Renal Physiol. 287:F124-F138.
18. Lowance, D., H.-H. Neumayer, C. M. Legendre, J.-P. Squifflet, J. Kovarik, P. J. Brennan, D. Norman, R. Mendez, M. R. Keating, G. L. Coggon, A. Crisp, I. C. Lee, et al. 1999. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. N. Engl. J. Med. 340:1462-1469.
19. Martin, D. F., J. Sierra-Madero, S. Walmsley, R. A. Wolitz, K. Macey, P. Georgiou, C. A. Robinson, and M. J. Stempien. 2002. A controlled trial of valganciclovir as induction therapy for cytomegalovirus retinitis. N. Engl. J. Med. 346:1119-1126.
20. Muheim, C., G. Vogel, C. Seydoux, M. Gillet, F. Mosimann, L. Von Segesser, R. Sahli, C. Estrade, G. Van Melle, and P. R. Meylan. 2002. Determinants of protracted cytomegalovirus infection in solid-organ transplant patients. Transplantation 74:226-236.
21. Paya, C., A. Humar, E. Dominguez, K. Washburn, E. Blumberg, B. Alexander, R. Freeman, N. Heaton, M. D. Pescovitz, et al. 2004. Efficacy and safety of valganciclovir versus oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am. J. Transplant. 4:611-620.
22. Perrottet, N., A. Beguin, P. Meylan, M. Pascual, O. Manuel, T. Buclin, J. Biollaz, and L. A. Decosterd. 2007. Determination of aciclovir and ganciclovir in human plasma by liquid chromatography-spectrofluorimetric detection and stability studies in blood samples. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 852:420-429.
23. Perrottet, N., C. Robatel, P. Meylan, M. Pascual, J. P. Venetz, J. D. Aubert, M. M. Berger, L. A. Decosterd, and T. Buclin. 2008. Disposition of valganciclovir during continuous renal replacement therapy in two lung transplant recipients. J. Antimicrob. Chemother. 61:1332-1335.
24. Pescovitz, M. D., J. Rabkin, R. M. Merion, C. V. Paya, J. Pirsch, R. B. Freeman, J. O'Grandy, C. Robinson, T. Zung, K. Wren, L. Banken, W. Buhles, and F. Brown. 2000. Valganciclovir results in improved oral absorption of ganciclovir in liver transplant recipients. Antimicrob. Agents Chemother. 44:2811-2815.
25. Preiksaitis, J. K., D. C. Brennan, J. A. Fishmann, and U. Allen. 2005. Canadian Society of Transplantation consensus workshop on cytomegalovirus management in solid organ transplantation final report. Am. J. Transplant. 5:218-227.
26. Rodrigo, E., G. Fernández-Fresnedo, J. C. Ruiz, C. Piňera, M. Hera, A. L. M. de Francsico, S. Sanz de Castro, J. G. Cotorruelo, J. A. Zubimendi, and M. Arias. 2003. Assessment of glomerular filtration rate in transplant recipients with severe renal insufficiency by Nankivell, modificication of diet in renal disease (MDRD), and Cockroft-Gault equations. Transplant. Proc. 35:1671-1672.
27. Scott, J. C., N. Partovi, and M. H. H. Ensom. 2004. Ganciclovir in solid organ transplant recipients. Is there a role for clinical pharmacokinetic monitoring? Ther. Drug Monit. 26:68-77.
28. Sommadossi, J. P., and R. Carlisle. 1987. Toxicity of 3′-azido-3′-deoxythymidine and 9-(1,3-dihydroxy-2-propoxymethyl) guanine for normal human hematopoietic progenitor cells in vitro. Antimicrob. Agents Chemother. 31:452-454.
29. Takeda, M., S. Khamdang, S. Narikawa, H. Kimura, Y. Kobayashi, T. Yamamoto, S. H. Cha, T. Sekine, and H. Endou. 2002. Human organic anion transporters and human organic cation transporters mediate renal antiviral transport. J. Pharmacol. Exp. Therapeut. 300:918-924.
30. Reference deleted.
31. Wählby, U., A. H. Thomson, P. A. Miligan, and M. O. Karlsson. 2004. Models for time varying covariates in population pharmacokinetic- pharmacodynamic analysis. Br. J. Clin. Pharmacol. 58:367-377.
32. Wiltshire, H., S. Hirankarn, C. Farrell, C. Paya, M. D. Pescovitz, A. Humar, E. Dominguez, K. Washburn, E. Blumberg, B. Alexander, R. Freeman, N. Heaton, et al. 2005. Pharmacokinetic profile of ganciclovir after its oral administration and from its prodrug, valganciclovir, in solid organ transplant recipients. Clin. Pharmacokinet. 44:495-507.
33. Wiltshire, H., C. Paya, M. D. Pescovitz, A. Humar, E. Dominguez, K. Washburn, E. Blumberg, B. Alexander, R. Freeman, N. Heaton, K. P. Zuideveld, et al. 2005. Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients. Transplantation 79:1477-1483.
34. Wolfe, E. J., V. Mathur, S. Tomlanovich, D. Jung, R. Wong, K. Griffy, and F. T. Aweeka. 1997. Pharmacokinetics of mycophenolate mofetil and intravenous ganciclovir alone and in combination in renal transplant recipients. Pharmacotherapy 17:591-598.