Cytomegalovirus incidence between everolimus versus mycophenolate in de novo renal transplants: Pooled analysis of three clinical trials

American Journal of Transplantation

Volumn 11, Issue 11, 2011, Pages 2453-2462

  Brennan, D C ^a   Legendre, C ^b   Patel, D ^c   Mange, K ^c   Wiland, A ^c   McCague, K ^c   Shihab, F S ^d  

^a WASHINGTON UNIVERSITY   (United States)

^b UNIVERSITÉ PARIS DESCARTES   (France)

^c NOVARTIS PHARMA AG   (Switzerland)

^d UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

Author keywords

Cytomegalovirus; Everolimus; Mycophenolic acid; Renal transplantation

Indexed keywords

ACICLOVIR; BASILIXIMAB; CORTICOSTEROID; CYCLOSPORIN A; CYTOMEGALOVIRUS ANTIBODY; EVEROLIMUS; GANCICLOVIR; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; STEROID; THYMOCYTE ANTIBODY; VALACICLOVIR;

ARTICLE; CYTOMEGALOVIRUS INFECTION; GRAFT RECIPIENT; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFECTION PREVENTION; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; META ANALYSIS; MULTICENTER STUDY (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; SYSTEMATIC REVIEW; VIREMIA;

ADULT; ANTIVIRAL AGENTS; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTIONS; FEMALE; GANCICLOVIR; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KAPLAN-MEIER ESTIMATE; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; RETROSPECTIVE STUDIES; SIROLIMUS; VIREMIA;

EID: 84857194014     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2011.03674.x     Document Type: Article

References (38)

1. Charfeddine K, Zaghden S, Kharrat M, Kamoun K, Jarraya F, Hachicha J. Infectious complications in kidney transplant recipients: A single-center experience. Transplant Proc 2005; 37: 2823-2825. (Pubitemid 41354744)
2. George JA, Rama T, Scott AG, et al. Infectious complications after kidney transplantation: Current epidemiology and associated risk factors. Clin Transplant 2006; 20: 401-409.
3. Hwang EA, Kang MJ, Han SY, Park SB, Kim HC. Viral infection following kidney transplantation: Long-term follow-up in a single center. Transplant Proc 2004; 36: 2118-2119. (Pubitemid 39424347)
4. Brennan DC, Garlock KA, Singer GG, et al. Prophylactic oral ganciclovir compared with deferred therapy for control of cytomegalovirus in renal transplant recipients. Transplantation 1997; 64: 1843-1846. (Pubitemid 28041727)
5. Lowance D, Neumayer HH, Legendre CM, et al. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. N Engl J Med 1999; 340: 1462-1470. (Pubitemid 29220545)
6. Reischig T, Jindra P, Mares J, et al. Valacyclovir for cytomegalovirus prophylaxis reduces the risk of acute renal allograft rejection. Transplantation 2005; 79: 317-324. (Pubitemid 40299538)
7. Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir versus oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 2004; 4: 611-620. (Pubitemid 38523584)
8. Hartmann A, Sagedal S, Hjelmesaeth J. The natural course of cytomegalovirus infection and disease in renal transplant recipients. Transplantation 2006; 82(2 Suppl): S15-S17. (Pubitemid 44126861)
9. 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)
10. 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)
11. Reischig T. Cytomegalovirus-associated renal allograft rejection: New challenges for antiviral preventive strategies. Expert Rev Anti-infective Ther 2010; 8: 903-910.
12. Reischig T, Jindra P, Hes O, Bouda M, Kormunda S, Treska V. Effect of cytomegalovirus viremia on subclinical rejection or interstitial fibrosis and tubular atrophy in protocol biopsy at 3 months in renal allograft recipients managed by preemptive therapy or antiviral prophylaxis. Transplantation 2009; 87: 436-444.
13. Helanterä I, Kyllönen L, Lautenschlager I, Salmela K, Koskinen P. Primary CMV infections are common in kidney transplant recipients after 6 months valganciclovir prophylaxis. Am J Transplant 2010; 10: 2026-2032.
14. Arthurs Supha AK, Eid Albert AJ, Pedersen Rachel AA, et al. Delayed-onset primary cytomegalovirus disease and the risk of allograft failure and mortality after kidney transplantation. Clinical Infectious Diseases 2008; 46: 840-846.
15. Becker BN, Becker YT, Leverson GE, Simmons WD, Sollinger HW, Pirsch JD. Reassessing the impact of cytomegalovirus infection in kidney and kidney-pancreas transplantation. Am J Kidney Dis 2002; 39: 1088-1095. (Pubitemid 34454229)
16. Schuler W, Sedrani R, Cottens S, et al. SDZ RAD, a newrapamycin derivative: Pharmacological properties in vitro and in vivo. Transplantation 1997; 64: 36-42. (Pubitemid 27327197)
17. Vitko S, Tedesco H, Eris J, et al. Everolimus with optimized cyclosporine dosing in renal transplant recipients: 6-month safety and efficacy results of two randomized studies. Am J Transplant 2004; 4: 626-635. (Pubitemid 38523586)
18. Tedesco-Silva H, Vitko S, Pascual J, et al. 12-month safety and efficacy of everolimus with reduced exposure cyclosporine in de novo renal transplant recipients. Transplant Int 2007; 20: 27-36.
19. Viganó M, Dengler T, Mattei MF, et al. Lower incidence of cytomegalovirus infection with everolimus versus mycophenolate mofetil in de novo cardiac transplant recipients: A randomized, multicenter study. Transplant Infect Dis 2010; 12: 23-30.
20. Vítko Š , Margreiter R, Weimar W, et al. Three-year efficacy and safety results from a study of everolimus versus mycophenolatemofetil in de novo renal transplant patients. Am J Transplant 2005; 5: 2521-2530.
21. Moorman NJ, Shenk T. Rapamycin-resistant mTORC1 kinase activity is required for herpesvirus replication. J Virol 2010; 84: 5260-5269.
22. Vítko Š , Margreiter R, Weimar W, et al. Everolimus (CerticanTM) 12-month safety and efficacy versus mycophenolate mofetil in de novo renal transplant recipients. Transplantation 2004; 78: 1532-1540. (Pubitemid 39552941)
23. Lorber M, Mulgaonkar S, Butt K, et al. Everolimus versus mycophenolate mofetil in the prevention of rejection in de novo renal transplant recipients: A 3-year randomized, multicenter, phase III study. Transplantation 2005; 80: 244-252. (Pubitemid 41061682)
24. Tedesco Silva Jr. H, Cibrik D, Johnston T, et al. Everolimus plus reduced-exposure CsA versus mycophenolic acid plus standardexposure CsA in renal-transplant recipients. Am J Transplant 2010; 10: 1401-1413.
25. Kletzmayr J, Kotzmann H, Popow-Kraupp T, Kovarik J, Klauser R. Impact of high-dose oral acyclovir prophylaxis on cytomegalovirus (CMV) disease in CMV high-risk renal transplant recipients. J Am Soc Nephrol 1996; 7: 325-330. (Pubitemid 26092483)
26. Rostaing L MO, Cisterne JM, Icart J, Chabannier MH, Durand D. CMV prophylaxis in high-risk renal transplant patients (D+/R-) by acyclovir with or without hyperimmune (CMV) immunoglobulins: A prospective study. Am J Nephrol 1997; 17: 489-494. (Pubitemid 27499847)
27. Hjelmesaeth J, Müller F, Jenssen T, Rollag H, Sagedal S, Hartmann A. Is there a link between cytomegalovirus infection and new-onset post-transplantation diabetes mellitus? Potential mechanisms of virus induced b-cell damage. Nephrol Dial Transplant 2005; 20: 2311-2315. (Pubitemid 41548852)
28. Legendre C, Norman D, Keating M, Maclaine G, Grant D. Valaciclovir prophylaxis of cytomegalovirus infection and disease in renal transplantation: An economic evaluation. Transplantation 2000; 70: 1463-1468.
29. Kim W, Badley A, Wiesner R, et al. The economic impact of cytomegalovirus infection after liver transplantation. Transplantation 2000; 69: 357-361. (Pubitemid 30118114)
30. Schnitzler M. Costs and consequences of cytomegalovirus disease. Am J Health Syst Pharm 2003; 60(23 Suppl 8): S5-S8.
31. Papanikolaou V, Vrochides D, Margari P, et al. Use of everolimus in de novo renal recipients: Initial experience in the Greek population. Transplant Proc 2008; 40: 3166-3169.
32. Webster A, Lee V, Chapman J, Craig J. Target of rapamycin inhibitors (TOR-I; sirolimus and everolimus) for primary immunosuppression in kidney transplant recipients. Cochrane Database Syst Rev 2006; 19: CD004290.
33. Eisen HJ, Tuzcu EM, Dorent R, et al. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med 2003; 349: 847-858. (Pubitemid 37025404)
34. Fortun J, Martin-Davila P, Pascual J, et al. Immunosuppressive therapy and infection after kidney transplantation. Transplant Infect Dis 2010; 12: 397-405.
35. Guba M PJ, Hugo C, Krämer BK, et al;. SMART-Study Group. Renal function, efficacy, and safety of sirolimus and mycophenolate mofetil after short-term calcineurin inhibitor-based quadruple therapy in de novo renal transplant patients: One-year analysis of a randomized multicenter trial. Transplantation 2010; 90: 175-183.
36. Demopoulos L, Polinsky M, Steele G, et al. Reduced risk of cytomegalovirus infection in solid organ transplant recipients treated with sirolimus: A pooled analysis of clinical trials. Transplant Proc 2008; 40: 1407-1410. (Pubitemid 351853135)
37. Clippinger AJ,Maguire TG, Alwine JC. The changing role of mammalian target of Rapamycin (mTOR) kinase in the maintenance of protein synthesis during human cytomegalovirus infection. J Virol 2011; 85: 3930-3939.
38. Hodson EM CJ, Strippoli GF, Webster AC. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev 2008; 16: CD003774.