Objective: To compare patient survival, graft survival and financial costs at 3 years after renal transplant in graft recipients who received pre-emptive or deferred treatment of cytomegalovirus (CMV) disease. Clinical outcomes and CMV-related charges at an average of 16 months’ follow-up have been reported previously.
Design and Setting: This was a randomised, nonblind trial in patients enrolled between June and December 1994 at a single US centre. Patients and Participants: 36 adult renal transplant recipients who themselves, or their donors, were CMV-seropositive were randomised into 15 patients in the pre-emptive treatment group and 21 patients in the deferred treatment group.
Methods: Patients in the pre-emptive treatment group received intravenous ganciclovir 5 mg/kg every 12 hours once CMV viraemia was detected. Patients in the deferred treatment group received the same intravenous ganciclovir regimen after developing symptomatic CMV disease. Cost data were collected for inpatient hospitalisations, outpatient intravenous medications and dialysis treatments.
Results: A comparison of the descriptive characteristics of the two groups revealed no significant differences. Three of 15 patients in the pre-emptive group died with graft function during the third year post-transplant, whereas none of 21 patients in the deferred group died during the study. However, none of the 3 deaths appear to be causally related to the study (myocardial infarction, lung cancer and homicide). Estimates of graft failure, censored for death with function, show a trend towards more graft loss in the deferred treatment group (p = 0.089). Average treatment costs were not significantly different during the first year post-transplant. However, by the third year post-transplant, costs were significantly higher in the deferred group (an additional $US15 277/patient, p < 0.001).
Conclusions: With an average of 16 months’ follow-up and an assessment of CMV-related charges, it was concluded that the deferred strategy was preferred because of equivalent clinical outcomes at lower CMV treatment charges. The results of the current study with 3-year follow-up and an analysis of total post-transplant treatment costs reverses the previous conclusion. We now conclude that a pre-emptive strategy for treating CMV disease is preferred because of similar clinical outcomes with lower total medical costs.
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This work was supported in part by a grant from the Missouri Kidney Program.
Rubin RH. Infection in the renal and liver transplant patient. In: Rubin RH, Young LS, editors. Clinical approach to infection in the compromised host. 2nd ed. New York (NY): Plenum Medical Books, 1988:557CrossRefGoogle Scholar
Fryd DS, Peterson PK, Ferguson RM, et al. Cytomegalovirus as a risk factor in renal transplantation. Transplantation 1980; 30: 436–9PubMedCrossRefGoogle Scholar
Brennan DC, Burton KG, Singer GG, et al. Prophylactic oral ganciclovir compared with deferred therapy for control of cytomegalovirus in renal transplant recipients. Transplantation 1997; 64(12): 1843–6PubMedCrossRefGoogle Scholar
Schnitzler MA, Woodward RS, Flavin K, et al. Clinical and economic impact of oral ganciclovir prophylaxis of CMV disease in renal transplantation [abstract no. 60]. Transplantation 1998; 65(8): 93CrossRefGoogle Scholar
Schnitzler MA, Woodward RS, Brennan DC, et al. The effects of cytomegalovirus serology on graft and recipient survival in cadaveric renal transplantation: implications for organ allocation. Am J Kidney Dis 1997; 29(3): 428–34PubMedCrossRefGoogle Scholar
Schnitzler MA, Woodward RS, Brennan DC, et al. Impact of cytomegalovirus serology on graft survival in living related renal transplantation: implications for donor selection. Surgery 1997; 121(5): 563–8PubMedCrossRefGoogle Scholar
Schnitzler MA, Woodward RS, Brennan DC, et al. Cytomegalovirus and HLA-A, B, and DR locus interactions: impact on renal transplant graft survival. Am J Kidney Dis 1997; 30(6): 766–71PubMedCrossRefGoogle Scholar
Tsevat J, Snydman DR, Pauker SG, et al. Which renal transplant patients should receive cytomegalovirus immune globulin? A cost-effectiveness analysis. Transplantation 1991; 52(2): 259–65PubMedCrossRefGoogle Scholar
McCarthy M, Krueger KM, Keown P. The cost impact of cytomegalovirus disease in renal transplant recipients. Transplantation 1993; 55: 1277–82PubMedCrossRefGoogle Scholar
Davis CL. The prevention of cytomegalovirus disease in renal transplantation. Am J Kidney Dis 1990; 16(3): 175–88PubMedGoogle Scholar
Falagas ME, Arbo M, Ruthazer R, et al. Cytomegalovirus disease is associated with increased cost and hospital length of stay among orthotopic liver transplant recipients. Transplantation 1997; 63(11): 1595–601PubMedCrossRefGoogle Scholar
Woodward RS, Schnitzler MA, Ceriotti CS, et al. The cost of CMV disease in renal transplantation [abstract no. 212]. Transplantation 1998; 65(8): 131CrossRefGoogle Scholar
Patel R, Snydman DR, Rubin RH, et al. Cytomegalovirus prophylaxis in solid organ transplant recipients. Transplantation 1996; 61: 1279–89PubMedCrossRefGoogle Scholar
Balfour HH, Chace BA, Stapleton JT, et al. A randomized placebo-controlled trial of oral acyclovir for the prevention of cytomegalovirus disease in recipients of renal transplants. N Engl J Med 1989; 320: 1381–7PubMedCrossRefGoogle Scholar
Bailey TC, Ettinger NA, Storch GA, et al. Failure of high-dose acyclovir with or without immune globulin to prevent primary cytomegalovirus disease in recipients of solid organ transplants. Am J Med 1993; 95: 273–8PubMedCrossRefGoogle Scholar
Brennan DC, Garlock KA, Lippmann BJ, et al. Control of cytomegalovirus associated morbidity in renal transplant patients using intensive monitoring and either preemptive or deferred therapy. J Am Soc Nephrol 1997; 8: 118–25PubMedGoogle Scholar
Hogg RV, Craig AT. Introduction to mathematical statistics. 4th ed. New York: Macmillan Publishing, 1978Google Scholar