Valganciclovir for the prevention and treatment of CMV in solid organ transplant recipients

Expert Opinion on Pharmacotherapy

Volumn 11, Issue 7, 2010, Pages 1159-1166

  Åsberg, Anders ^a   Rollag, Halvor ^a   Hartmann, Anders ^a  

^a UNIVERSITY OF OSLO   (Norway)

Author keywords

Cytomegalovirus; Deferred; Ganciclovir; Oral; Pre emptive; Prophylaxis; Solid organ transplantation; Treatment

Indexed keywords

CIDOFOVIR; FOSCARNET; GANCICLOVIR; GRANULOCYTE COLONY STIMULATING FACTOR; LYMPHOCYTE ANTIBODY; METHYLPREDNISOLONE; VALGANCICLOVIR;

ANEMIA; ANTIVIRAL ACTIVITY; ANTIVIRAL THERAPY; CLINICAL TRIAL; COMPETITIVE INHIBITION; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG STRUCTURE; DRUG SUBSTITUTION; DRUG WITHDRAWAL; GASTROINTESTINAL SYMPTOM; GRAFT RECIPIENT; HUMAN; INCIDENCE; INFECTION PREVENTION; KIDNEY TRANSPLANTATION; LEUKOPENIA; NAUSEA; NEUROLOGIC DISEASE; ORGAN TRANSPLANTATION; PRACTICE GUIDELINE; REVIEW; SKIN DISEASE; VIREMIA; VIRUS REACTIVATION;

ANTIVIRAL AGENTS; BIOLOGICAL AVAILABILITY; CYTOMEGALOVIRUS INFECTIONS; GANCICLOVIR; HUMANS; IMMUNOCOMPROMISED HOST; ORGAN TRANSPLANTATION; PRODRUGS;

EID: 77951279597     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656561003742954     Document Type: Review

References (66)

1. Rubin RH. Impact of cytomegalovirus infection on organ transplant recipients. Rev Infect Dis 1990;12(Suppl 7):S754-66 (Pubitemid 20311817)
2. Cytomegalovirus. Am J Transplant 2004;10:51-58
3. Paya CV. Prevention of cytomegalovirus disease in recipients of solid-organ transplants. Clin Infect Dis 2001;32:596-603 (Pubitemid 32565001)
4. Skar AG, Hoddevik G. Prevalence of cytomegalovirus antibodies in Norwegian kidney-transplant recipients and their living donors. A comparative study of two different methods. Acta Pathol Microbiol Immunol Scand B 1984;92:1-5 (Pubitemid 14196572)
5. Sinclair J. Human cytomegalovirus: latency and reactivation in the myeloid lineage. J Clin Virol 2008;41:180-185
6. 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;70:1166-1174
7. Burke GW III, Kaufman DB, Millis JM, et al. Prospective, randomized trial of the effect of antibody induction in simultaneous pancreas and kidney transplantation: three-year results. Transplantation 2004;77:1269-1275
8. Razonable RR, Rivero A, Rodriguez A, et al. Allograft rejection predicts the occurrence of late-onset cytomegalovirus (CMV) disease among CMV-mismatched solid organ transplant patients receiving prophylaxis with oral ganciclovir. J Infect Dis 2001;184:1461-1464 (Pubitemid 33108862)
9. Fishman JA, Rubin RH. Infection in organ-transplant recipients. N Engl J Med 1998;338:1741-1751
10. Hjelmesaeth J, Sagedal S, Hartmann A, et al. Asymptomatic cytomegalovirus infection is associated with increased risk of new-onset diabetes mellitus and impaired insulin release after renal transplantation. Diabetologia 2004;47:1550-1556 (Pubitemid 39371637)
11. Nett PC, Heisey DM, Fernandez LA, et al. Association of cytomegalovirus disease and acute rejection with graft loss in kidney transplantation. Transplantation 2004;78:1036-1041 (Pubitemid 39391867)
12. Rosen HR, Corless CL, Rabkin J, Chou S. Association of cytomegalovirus genotype with graft rejection after liver transplantation. Transplantation 1998;66:1627-1631 (Pubitemid 29034982)
13. Sagedal S, Hartmann A, Nordal KP, et al. Impact of early cytomegalovirus infection and disease on long-term recipient and kidney graft survival. Kidney Int 2004;66:329-337 (Pubitemid 38870110)
14. Sagedal S, Nordal KP, Hartmann A, et al. The impact of cytomegalovirus infection and disease on rejection episodes in renal allograft recipients. Am J Transplant 2002;2:850-856 (Pubitemid 36306840)
15. Sagedal S, Rollag H, Hartmann A. Cytomegalovirus infection in renal transplant recipients is associated with impaired survival irrespective of expected mortality risk. Clin Transplant 2007;21:309-313 (Pubitemid 46711391)
16. Bailey TC, Trulock EP, Ettinger NA, et al. Failure of prophylactic ganciclovir to prevent cytomegalovirus disease in recipients of lung transplants. J Infect Dis 1992;165:548-552
17. 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. The Oral Ganciclovir International Transplantation Study Group. Lancet 1997;350:1729-1733 (Pubitemid 28036671)
18. Merigan TC, Renlund DG, Keay S, et al. A controlled trial of ganciclovir to prevent cytomegalovirus disease after heart transplantation. N Engl J Med 1992;326:1182-1186
19. Patel R, Snydman DR, Rubin RH, et al. Cytomegalovirus prophylaxis in solid organ transplant recipients. Transplantation 1996;61:1279-1289 (Pubitemid 26155045)
20. Smyth RL, Scott JP, Borysiewicz LK, et al. Cytomegalovirus infection in heart-lung transplant recipients: risk factors, clinical associations, and response to treatment. J Infect Dis 1991;164:1045-1050
21. Soghikian MV, Valentine VG, Berry GJ, et al. Impact of ganciclovir prophylaxis on heart-lung and lung transplant recipients. J Heart Lung Transplant 1996;15:881-887 (Pubitemid 26320212)
22. Duncan AJ, Dummer JS, Paradis IL, et al. Cytomegalovirus infection and survival in lung transplant recipients. J Heart Lung Transplant 1991;10:638-646
23. Ettinger NA, Bailey TC, Trulock EP, et al. Cytomegalovirus infection and pneumonitis. Impact after isolated lung transplantation. Washington University Lung Transplant Group. Am Rev Respir Dis 1993;147:1017-1023
24. Hibberd PL, Tolkoff-Rubin NE, Conti D, et al. Preemptive ganciclovir therapy to prevent cytomegalovirus disease in cytomegalovirus antibody-positive renal transplant recipients. A randomized controlled trial. Ann Intern Med 1995;123:18-26
25. Perrottet N, Decosterd LA, Meylan P, et al. Valganciclovir in adult solid organ transplant recipients: pharmacokinetic and pharmacodynamic characteristics and clinical interpretation of plasma concentration measurements. Clin Pharmacokinet 2009;48:399-418
26. Sugawara M, Huang W, Fei YJ, et al. Transport of valganciclovir, a ganciclovir prodrug, via peptide transporters PEPT1 and PEPT2. J Pharm Sci 2000;89:781-789
27. Pescovitz MD, Rabkin J, Merion RM, et al. Valganciclovir results in improved oral absorption of ganciclovir in liver transplant recipients. Antimicrob Agents Chemother 2000;44:2811-2815
28. Vaudry W, Ettenger R, Jara P, et al. Valganciclovir dosing according to body surface area and renal function in pediatric solid organ transplant recipients. Am J Transplant 2009;9:636-643
29. Martin JC, Dvorak CA, Smee DF, et al. 9-[(1,3-Dihydroxy-2-propoxy)methyl] guanine: a new potent and selective antiherpes agent. J Med Chem 1983;26:759-761
30. Agbaria R, Candotti F, Kelley JA, et al. Biosynthetic ganciclovir triphosphate: its isolation and characterization from ganciclovir-treated herpes simplex thymidine kinase-transduced murine cells. Biochem Biophys Res Commun 2001;289:525-530 (Pubitemid 33141086)
31. Åsberg A, Humar A, Rollag H, et al. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 2007;7:2106-2113 (Pubitemid 47247057)
32. Boivin G, Goyette N, Rollag H, et al. Cytomegalovirus resistance in solid organ transplant recipients treated with intravenous ganciclovir or oral valganciclovir. Antivir Ther 2009;14:697-704
33. Bhorade SM, Lurain NS, Jordan A, et al. Emergence of ganciclovir- resistant cytomegalovirus in lung transplant recipients. J Heart Lung Transplant 2002;21:1274-1282 (Pubitemid 35477741)
34. Isada CM, Yen-Lieberman B, Lurain NS, et al. Clinical characteristics of 13 solid organ transplant recipients with ganciclovir-resistant cytomegalovirus infection. Transpl Infect Dis 2002;4:189-194 (Pubitemid 36142804)
35. Boivin G, Goyette N, Gilbert C, et al. Clinical impact of ganciclovir-resistant cytomegalovirus infections in solid organ transplant patients. Transpl Infect Dis 2005;7:166-170 (Pubitemid 43015456)
36. Chou SW. Cytomegalovirus drug resistance and clinical implications. Transpl Infect Dis 2001;3(Suppl 2):20-24 (Pubitemid 34073652)
37. 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. Am J Transplant 2004;4:611-620 (Pubitemid 38523584)
38. Husain S, Pietrangeli CE, Zeevi A. Delayed onset CMV disease in solid organ transplant recipients. Transpl Immunol 2009;21:1-9
39. Humar A, Kumar D, Boivin G, Caliendo AM. Cytomegalovirus (CMV) virus load kinetics to predict recurrent disease in solid-organ transplant patients with CMV disease. J Infect Dis 2002;186:829-833 (Pubitemid 35013436)
40. Rollag H, Sagedal S, Kristiansen KI, et al. Cytomegalovirus DNA concentration in plasma predicts development of cytomegalovirus disease in kidney transplant recipients. Clin Microbiol Infect 2002;8:431-434 (Pubitemid 34993821)
41. Scalzo AA, Corbett AJ, Rawlinson WD, et al. The interplay between host and viral factors in shaping the outcome of cytomegalovirus infection. Immunol Cell Biol 2007;85:46-54 (Pubitemid 46067321)
42. Humar A, Uknis M, Carlone-Jambor C, et al. Cytomegalovirus disease recurrence after ganciclovir treatment in kidney and kidney-pancreas transplant recipients. Transplantation 1999;67:94-97 (Pubitemid 29061144)
43. Garg G, Kar P. Management of HCV infection: current issues and future options. Trop Gastroenterol 2009;30:11-18
44. G€orzer I, Kerschner H, Jaksch P, et al. Virus load dynamics of individual CMV-genotypes in lung transplant recipients with mixed-genotype infections. J Med Virol 2008;80:1405-1414 (Pubitemid 351897413)
45. Manuel O, Asberg A, Pang X, et al. Impact of genetic polymorphisms in cytomegalovirus glycoprotein B on outcomes in solid-organ transplant recipients with cytomegalovirus disease. Clin Infect Dis 2009;49:1160-1166
46. Nogueira E, Ozaki KS, Tomiyama H, et al. Clinical correlations of human cytomegalovirus strains and viral load in kidney transplant recipients. Int Immunopharmacol 2009;9:26-31
47. Sarcinella L, Mazzulli T, Willey B, Humar A. Cytomegalovirus glycoprotein B genotype does not correlate with outcomes in liver transplant patients. J Clin Virol 2002;24:99-105 (Pubitemid 34016019)
48. Preiksaitis JK, Brennan DC, Fishman J, Allen U. Canadian society of transplantation consensus workshop on cytomegalovirus management in solid organ transplantation final report. Am J Transplant 2005;5:218-227 (Pubitemid 40179508)
49. Humar A. The IMPACT Study: valganciclovir prophylaxis for until 200 days post-transplant in high risk kidney recipients substantially reduces the incidence of CMV disease [abstract 01]. Am J Transplant 2009;9(Suppl 2):248
50. Taber DJ, Ashcraft E, Baillie GM, et al. Valganciclovir prophylaxis in patients at high risk for the development of cytomegalovirus disease. Transpl Infect Dis 2004;6:101-109 (Pubitemid 40013049)
51. Zamora MR, Nicolls MR, Hodges TN, et al. Following universal prophylaxis with intravenous ganciclovir and cytomegalovirus immune globulin, valganciclovir is safe and effective for prevention of CMV infection following lung transplantation. Am J Transplant 2004;4:1635-1642
52. Khoury JA, Storch GA, Bohl DL, et al. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant 2006;6:2134-2143
53. Reischig T, Jindra P, Hes O, et al. Valacyclovir prophylaxis versus preemptive valganciclovir therapy to prevent cytomegalovirus disease after renal transplantation. Am J Transplant 2008;8:69-77
54. Freeman RB, Paya C, Pescovitz MD, et al. Risk factors for cytomegalovirus viremia and disease developing after prophylaxis in high-risk solid-organ transplant recipients. Transplantation 2004;78:1765-1773 (Pubitemid 40041643)
55. Sia IG, Wilson JA, Groettum CM, et al. Cytomegalovirus (CMV) DNA load predicts relapsing CMV infection after solid organ transplantation. J Infect Dis 2000;181:717-720
56. Åsberg A, Humar A, Jardine AG, et al. Long-term outcomes of CMV disease treatment with valganciclovir versus IV ganciclovir in solid organ transplant recipients. Am J Transplant 2009;9:1205-1213
57. West P, Schmiedeskamp M, Neeley H, et al. Use of high-dose ganciclovir for a resistant cytomegalovirus infection due to UL97 mutation. Transpl Infect Dis 2008;10:129-132 (Pubitemid 351393081)
58. Sagedal S, Nordal KP, Hartmann A, et al. Pre-emptive therapy of CMVpp65 antigen positive renal transplant recipients with oral ganciclovir: a randomized, comparative study. Nephrol Dial Transplant 2003;18:1899-1908 (Pubitemid 37098564)
59. Crumpacker CS. Ganciclovir. N Engl J Med 1996;335:721-729
60. McGavin JK, Goa KL. Ganciclovir: an update of its use in the prevention of cytomegalovirus infection and disease in transplant recipients. Drugs 2001;61:1153-1183
61. Zimmermann A, Michel D, Pavic I, et al. Phosphorylation of aciclovir, ganciclovir, penciclovir and S2242 by the cytomegalovirus UL97 protein: a quantitative analysis using recombinant vaccinia viruses. Antiviral Res 1997;36:35-42 (Pubitemid 27395711)
62. Brestrich G, Zwinger S, Fischer A, et al. Adoptive T-cell therapy of a lung transplanted patient with severe CMV disease and resistance to antiviral therapy. Am J Transplant 2009;9:1679-1684
63. Kim I, Song X, Vig BS, et al. A novel nucleoside prodrug-activating enzyme: substrate specificity of biphenyl hydrolase-like protein. Mol Pharm 2004;1:117-127
64. Perrottet N, Csajka C, Pascual M, et al. Population pharmacokinetics of ganciclovir in solid-organ transplant recipients receiving oral valganciclovir. Antimicrob Agents Chemother 2009;53:3017-3023
65. Caldes A, Colom H, Armendariz Y, et al. Population pharmacokinetics of ganciclovir after intravenous ganciclovir and oral valganciclovir administration in solid organ transplant patients infected with cytomegalovirus. Antimicrob Agents Chemother 2009;53:4816-4824
66. Pescovitz MD, Ettenger RB, Strife CF, et al. Pharmacokinetics of oral valganciclovir solution and intravenous ganciclovir in pediatric renal and liver transplant recipients. Transpl Infect Dis 2009 [Epub ahead of print]