Efficacy and safety of low-dose versus standard-dose valganciclovir for prevention of cytomegalovirus disease in intermediate-risk kidney transplant recipients

Experimental and Clinical Transplantation

Volumn 14, Issue 5, 2016, Pages 526-534

  Halim, Medhat A ^a   Al Otaibi, Torki ^a   Gheith, Osama ^a   Adel, Hani ^a   Mosaad, Ahmed ^a   Hasaneen, Abu Atteya ^a   Zakaria, Zakaria ^a   Makkeya, Yahya ^b   Said, Tarek ^a   Nair, Prasad ^a  

^a IBN SINA HOSPITAL   (Kuwait)

^b AIN SHAMS UNIVERSITY   (Egypt)

Author keywords

Immunosuppression; Rejection; Renal transplantation

Indexed keywords

BASILIXIMAB; CALCINEURIN INHIBITOR; GRANULOCYTE COLONY STIMULATING FACTOR; IMMUNOGLOBULIN; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM SUCCINATE; MYCOPHENOLATE MOFETIL; PREDNISONE; RITUXIMAB; THYMOCYTE ANTIBODY; VALGANCICLOVIR; ANTIVIRUS AGENT; GANCICLOVIR; IMMUNOSUPPRESSIVE AGENT;

ACUTE GRAFT REJECTION; ADULT; ANEMIA; ARTICLE; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DEMOGRAPHY; DIARRHEA; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; FEMALE; GRAFT RECIPIENT; GRAFT REJECTION; HEADACHE; HUMAN; INFECTION RISK; KIDNEY TRANSPLANTATION; LEUKOPENIA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; SIDE EFFECT; TREATMENT OUTCOME; ADVERSE EFFECTS; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; COMPARATIVE STUDY; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTIONS; DRUG ADMINISTRATION; DRUG EFFECTS; GRAFT SURVIVAL; IMMUNOCOMPROMISED PATIENT; IMMUNOLOGY; MIDDLE AGED; OPPORTUNISTIC INFECTIONS; PATHOGENICITY; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; TIME FACTOR; VIROLOGY; VIRUS ACTIVATION;

ADULT; ANTIVIRAL AGENTS; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTIONS; DRUG ADMINISTRATION SCHEDULE; FEMALE; GANCICLOVIR; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOCOMPROMISED HOST; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; LEUKOPENIA; MALE; MIDDLE AGED; OPPORTUNISTIC INFECTIONS; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; VIRUS ACTIVATION;

EID: 84992630748     PISSN: 13040855     EISSN: None     Source Type: Journal    
DOI: 10.6002/ect.2015.0305     Document Type: Article

References (45)

1. Kotton CN, Kumar D, Caliendo AM, et al; Transplantation Society International CMV Consensus Group. International consensus guidelines on the management of cytomegalovirus in solid organ transplantation. Transplantation. 2010;89(7):779-795.
2. Paya CV. Indirect effects of CMV in the solid organ transplant patient. Transpl Infect Dis. 1999;1 Suppl 1:8-12.
3. Rubin RH. The indirect effects of cytomegalovirus infection on the outcome of organ transplantation. JAMA. 1989;261(24):3607-3609.
4. Singh N. Preemptive therapy versus universal prophylaxis with ganciclovir for cytomegalovirus in solid organ transplant recipients. Clin Infect Dis. 2001;32(5):742-751.
5. Reusser P. Oral valganciclovir: a new option for treatment of cytomegalovirus infection and disease in immunocompromised hosts. Expert Opin Investig Drugs. 2001;10(9):1745-1753.
6. 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(1):329-337.
7. Razonable R, Humar A and the AST Infectious Diseases Community of Practice. Cytomegalovirus in solid organ transplantation. Am J Transplant.2013;13(Suppl 4):93-106.
8. Schnitzler MA, Lowell JA, Hardinger KL, Boxerman SB, Bailey TC, Brennan DC. The association of cytomegalovirus sero-pairing with outcomes and costs following cadaveric renal transplantation prior to the introduction of oral ganciclovir CMV prophylaxis. Am J Transplant. 2003;3(4):445-451.
9. 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 (11):1461-1464.
10. Wiltshire H, Hirankarn S, Farrell C, et al. Pharmacokinetic profile of ganciclovir after its oral administration and from its prodrug, valganciclovir, in solid organ transplant recipients. Clin Pharmacokinet. 2005;44:495-507.
11. 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(4):611-620.
12. Hodson EM, Ladhani M, Webster AC, Strippoli GFM, Craig JC. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database SystRev. 2013;2:CD003774.
13. De Keyzer K, Van Laecke S, Peeters P, Vanholder R. Human cytomegalovirus and kidney transplantation: a clinician’s update. Am J Kidney Dis. 2011;58(1):118-126.
14. Couchoud C. Cytomegalovirus prophylaxis with antiviral agents for solid organ transplantation. Cochrane Database Syst Rev. 2000 (2):CD001320.
15. Noble S, Faulds D. Ganciclovir. An update of its use in the prevention of cytomegalovirus infection and disease in transplant recipients. Drugs. 1998;56(1):115-146.
16. 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(12):1682-1688.
17. Pescovitz MD, Pruett TL, Gonwa T, et al. Oral ganciclovir dosing in transplant recipients and dialysis patients based on renal function. Transplantation. 1998;66(8):1104-1107.
18. Limaye AP, Corey L, Koelle DM, Davis CL, Boeckh M. Emergence of ganciclovir-resistant cytomegalovirus disease among recipients of solid-organ transplants. Lancet. 2000;356(9230):645-649.
19. Humar A, Lebranchu Y, Vincenti F, et al. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010;10(5):1228-1237.
20. Humar A, Limaye AP, Blumberg EA, et al. Extended valganciclovir prophylaxis in D+/R- kidney transplant recipients is associated with long-term reduction in cytomegalovirus disease: two-year results of the IMPACT study. Transplantation. 2010;90(12):1427-1431.
21. Trevillyan J, Angus P, Shelton E, et al. Electronic estimations of renal functions are inaccurate in solid-organ transplant recipients and can result in significant underdosing of prophylactic valganciclovir. Antimicrob Agents Chemother. 2013;57(8):4058-4060.
22. Penne EL, Nurmohamed SA. Underdosing of prophylactic valganciclovir due to inaccurate estimation of glomerular filtration rate leading to severe cytomegalovirus disease in a kidney transplant recipient. Antimicrob Agents Chemother. 2014;58(2): 1271-1272.
23. Kalil AC, Mindru C, Florescu DF. Effectiveness of valganciclovir 900 mg versus 450 mg for cytomegalovirus prophylaxis in transplantation: direct and indirect treatment comparison metaanalysis. Clin Infect Dis. 2011;52(3):313-321.
24. Rodrigo E, Fernández-Fresnedo G, Ruiz JC, et al. Similar impact of slow and delayed graft function on renal allograft outcome and function. Transplant Proc. 2005;37(3):1431-1432.
25. Mengel M, Sis B, Haas M, et al; Banff meeting report writing committee. Banff 2011 Meeting report: new concepts in antibody-mediated rejection. Am J Transplant. 2012;12(3):563-570.
26. Humar A, Michaels M. American Society of Transplantation recommendations for screening, monitoring and reporting of infectious complications in immunosuppression trials in recipients of organ transplantation. Am J Transplant. 2006;6(2):262-274.
27. De Rycke A, Dierickx D, Kuypers DR. Tacrolimus-induced neutropenia in renal transplant recipients. Clin J Am Soc Nephrol. 2011;6(3):690-694.
28. Zafrani L, Truffaut L, Kreis H, et al. Incidence, risk factors and clinical consequences of neutropenia following kidney transplantation: a retrospective study. Am J Transplant. 2009;9(8):1816-1825.
29. Pouteil-Noble C, Ecochard R, Betuel H, Dubernard JM, Aymard M, Touraine JL. HLA B and DR mismatching, a risk factor for cytomegalovirus infection after renal transplantation. Clin Transplant.1993;7:467.
30. Schnitzler MA, Lowell JA, Hmiel SP, et al. Cytomegalovirus disease after prophylaxis with oral ganciclovir in renal transplantation: the importance of HLA-DR matching. J Am Soc Nephrol. 2003;14 (3):780-785.
31. Krech U. Complement-fixing antibodies against cytomegalovirus in different parts of the world. Bull World Health Organ. 1973;49 (1):103-106.
32. Grinyó JM, Ekberg H, Mamelok RD, et al. The pharmacokinetics of mycophenolate mofetil in renal transplant recipients receiving standard-dose or low-dose cyclosporine, low-dose Tac or lowdose sirolimus: the Symphony pharmacokinetic substudy. Nephrol Dial Transplant. 2009;24(7):2269-2276.
33. Hartmann EL, Gatesman M, Roskopf-Somerville J, Stratta R, Farney A, Sundberg A. Management of leukopenia in kidney and pancreas transplant recipients. Clin Transplant. 2008;22(6):822-828.
34. Brum S, Nolasco F, Sousa J, et al. Leukopenia in kidney transplant patients with the association of valganciclovir and mycophenolate mofetil. Transplant Proc. 2008;40(3):752-754.
35. Viglietti D, Peraldi MN. [Cytopenias following kidney transplantation]. Nephrol Ther. 2011;7(6):474-478.
36. The Mycophenolate Mofetil Renal Refractory Rejection Study Group. Rescue therapy with mycophenolate mofetil. Clin Transplant. 1996;10(1 Pt 2):131-135.
37. Gonzalez-Molina M, Burgos D, Cabello M, et al. Impact of immunosuppression treatment on the improvement in graft survival after deceased donor renal transplantation: a long-term cohort study. Nefrologia 2014;34(5):570-578.
38. Nada R, Sachdeva MU, Sud K, Jha V, Joshi K. Co-infection by cytomegalovirus and BK polyoma virus in renal allograft, mimicking acute rejection. Nephrol Dial Transplant. 2005;20(5):994-996.
39. Hodson EM, Jones CA, Webster AC, et al. Antiviral medications to prevent cytomegalovirus disease and early death in recipients of solid-organ transplants: a systematic review of randomised controlled trials. Lancet. 2005;365(9477):2105-2115.
40. Chamberlain CE, Penzak SR, Alfaro RM, et al. Pharmacokinetics of low and maintenance dose valganciclovir in kidney transplant recipients. Am J Transplant. 2008;8(6):1297-1302.
41. Singh N. Antiviral drugs for cytomegalovirus in transplant recipients: advantages of preemptive therapy. Rev Med Virol. 2006;16(5):281-287.
42. Gabardi S, Magee CC, Baroletti SA, Powelson JA, Cina JL, Chandraker AK. Efficacy and safety of low dose valganciclovir for prevention of cytomegalovirus disease in renal transplant recipients: a single-center, retrospective analysis. Pharmacotherapy. 2004;24(10):1323-1330.
43. Weclawiak H, Mengelle C, Ould Mohamed A, Izopet J, Rostaing L, Kamar N. [Cytomegalovirus effects in solid organ transplantation and the role of antiviral prophylaxis.] Nephrol Ther. 2010;6(6):505-512.
44. Stevens DR, Sawinski D, Blumberg E, Galanakis N, Bloom RD, TrofeClark. Increased risk of breakthrough infection among cytomegalovirus donor-positive/recipient-negative kidney transplant recipients receiving lower-dose valganciclovir prophylaxis. J Transpl Infect Dis. 2015;17(2):163-173.
45. Gabardi S, Asipenko N, Fleming J, et al. Evaluation of low versus high dose valganciclovir for prevention of cytomegalovirus disease in high risk renal transplant recipients. Transplantation. 2015;99(7):1499-1505.