Pharmacokinetic profile of ganciclovir after its oral administration and from its prodrug, valganciclovir, in solid organ transplant recipients

Clinical Pharmacokinetics

Volumn 44, Issue 5, 2005, Pages 495-507

  Wiltshire, Hugh ^a   Hirankarn, Sarapee ^b   Farrell, Colm ^b   Paya, Carlos ^c   Pescovitz, Mark D ^d   Humar, Atul ^e   Dominguez, Edward ^f   Washburn, Kenneth ^g   Blumberg, Emily ^h   Alexander, Barbara ⁱ   Freeman, Richard ^j   Heaton, Nigel ^k  

^a ROCHE PRODUCTS LTD   (United Kingdom)

^b ICON PLC   (United Kingdom)

^c MAYO CLINIC   (United States)

^d INDIANA UNIVERSITY   (United States)

^e TORONTO GENERAL HOSPITAL   (Canada)

^f UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^g UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^h HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

ⁱ DUKE UNIVERSITY MEDICAL CENTER   (United States)

^j TUFTS MEDICAL CENTER   (United States)

^k KING'S COLLEGE LONDON   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GANCICLOVIR; VALGANCICLOVIR;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; COMPUTER PROGRAM; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG INDICATION; DRUG METABOLISM; FEMALE; HEART TRANSPLANTATION; HIGH RISK PATIENT; HUMAN; KIDNEY TRANSPLANTATION; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; ORGAN TRANSPLANTATION; PATIENT COMPLIANCE; POSTOPERATIVE INFECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ADULT; AGED; ANTIVIRAL AGENTS; AREA UNDER CURVE; CYTOMEGALOVIRUS INFECTIONS; FEMALE; GANCICLOVIR; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; ORGAN TRANSPLANTATION; PRODRUGS;

EID: 21144452373     PISSN: 03125963     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003088-200544050-00003     Document Type: Article

References (29)

1. Pereyra F, Rubin RH. Prevention and treatment of cytomegalovirus infection in solid organ transplant recipients. Curr Opin Infect Dis 2004; 17: 357-61
2. Sagedal S, Nordal KP, Hartmann A, et al. A prospective study of the natural course of cytomegalovirus infection and disease in renal allograft recipients. Transplantation 2000; 70: 1166-74
3. Sancho A, Gorriz JL, Crespo JF, et al. Prophylaxis of cytomegalovirus disease with intravenous ganciclovir in renal transplantation. Transplant Proc 1999; 31: 2337-8
4. Wreghitt TG, Abel SJ, McNeil K, et al. Intravenous ganciclovir prophylaxis for cytomegalovirus in heart, heart-lung, and lung transplant recipients. Transpl Int 1999; 12: 254-60
5. Gane E, Saliba F, Valdecasas GJ, et al. Randomised trial of efficacy and safety of oral ganciclovir in the prevention of cytomegalovirus disease in liver transplant recipients. Lancet 1997; 350: 1729-33
6. Paya CV, Wilson JA, Espy MJ, et al. Preemptive use of oral ganciclovir to prevent cytomegalovirus infection in liver transplant patients: a randomized, placebo-controlled trial. J Infect Dis 2002; 185: 854-60
7. Hertz MI, Jordan C, Savik SK, et al. Randomized trial of daily versus three-times-weekly prophylactoc ganciclovir after lung and heart-lung transplantation. J Heart Lung Transplant 1998; 17: 913-20
8. Pescovitz MD, Pruett TL, Gonwa T, et al. Oral ganciclovir dosing in transplant recipients and dialysis patients based on renal function. Transplantation 1998; 66: 1104-7
9. Pescovitz MD, Rabkin J, Merion RM, et al. Valganciclovir results in improved oral absorption of ganciclovir in liver transplant recipients. Antimicrob Agents Chemother 2000; 44: 2811-5
10. Jung D, Dorr A. Single-dose pharmacokinetics of valganciclovir in HIV- and CMV-seropositive subjects. J Clin Pharmacol 1999; 39: 800-4
11. Czock D, Scholle C, Rasche FM, et al. Pharmacokinetics of valganciclovir and ganciclovir in renal impariment. Clin Pharmacol Ther 2002; 72: 142-50
12. Martin DF, Sierra-Madero J, Walmsley S, et al. A controlled trial of valganciclovir as induction therapy for cytomegalovirus retinitis. N Engl J Med 2002; 346: 1119-26
13. Brown F, Banken L, Say well K, et al. Pharmacokinetics of valganciclovir and ganciclovir following multiple oral dosages of valganciclovir in HIV- and CMV-seropositive volunteers. Clin Pharmacokinet 1999; 37: 167-76
14. Pescovitz MD. Oral ganciclovir and pharmacokinetics of valganciclovir in liver transplant recipients. Transpl Infect Dis 1999; 1: 31-4
15. Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir vs oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Valganciclovir Solid Organ Transplant Study Group. Am J Transplant 2004; 4: 611-20
16. Chu F, Kiang CH, Sung ML, et al. A rapid, sensitive HPLC method for the determination of ganciclovir in human plasma and serum. J Pharm Biomed Anal 1999; 21: 657-67
17. Beal SL, Boeckmann A, Sheiner LB. NONMEM users guide (Pt 1): VIII. San Franscisco (CA): NONMEM Project Group C255, University of California at San Francisco, 1988-1998
18. Karlsson MO, Jonsson EN, Wiltse CG, et al. Assumption testing in population pharmacokinetic models: illustrated with an analysis of moxonidine data from congestive heart failure patients. J Pharmacokinet Biopharm 1998; 26: 207-46
19. Beal SL, Sheiner LB. NONMEM users guides. San Francisco (CA): NONMEM Project Group, University of California, 1992
20. Winston DJ, Imagawa DK, Holt CD, et al. Long-term ganciclovir prophylaxis eliminates serious cytomegalovirus disease in liver transplant recipients receiving OKT3 therapy for rejection. Transplantation 1995; 60: 1357-60
21. Seu P, Winston DJ, Holt CD, et al. Long-term ganciclovir prophylaxis for successful prevention of primary cytomegalovirus (CMV) disease in CMV-seronegative liver transplant recipients with CMV-seropositive donors. Transplantation 1997; 64: 1614-7
22. Flechner SM, Avery RK, Fisher R, et al. A randomized prospective controlled trial of oral acyclovir versus oral ganciclovir for cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Transplantation 1998; 66: 1682-8
23. Griffy KG. Pharmacokinetics of oral ganciclovir capsules in HIV-infected persons. AIDS 1996; 10 Suppl. 4: S3-6
24. Ganapathy ME, Huang W, Wang H, et al. Valacyclovir: a substrate for the intestinal and peptide transporters PEPT1 and PEPT2. Biochem Biophys Res Commun 1998; 19: 470-5
25. Sinko PJ, Balimane PV. Carrier-mediated intestinal absorption of valacyclovir, the L-valyl ester prodrug of acyclovir; interactions with peptides, organic anions and organic cations in rats. Biopharm Drug Dispos 1998; 19: 209-17
26. Lake KD, Fletcher CV, Love KR, et al. Ganciclovir pharmacokinetics during renal impairment. Antimicrob Agents Chemother 1988; 32: 1899-900
27. Sommadossi JP, Bevan R, Ling T, et al. Clinical pharmacokinetics of ganciclovir in patients with normal and impaired renal function. Rev Infect Dis 1988; 10 Suppl. 3: S507-14
28. Paladino JA, Kapfer JA, DiBona JR. Bedside estimation of creatinine clearance: which method is most accurate while least complex? Hosp Formul 1986; 21: 709-15
29. Fishman JA, Doran MT, Volpicelli SA, et al. Dosing of intravenous ganciclovir for the prophylaxis and treatment of cytomegalovirus infection in solid organ transplant recipients. Transplantation 2000; 69: 389-94