Improvement in long-term renal graft survival due to CMV prophylaxis with oral ganciclovir: results of a randomized clinical trial.
Oral ganciclovir prophylaxis and intravenous preemptive therapy are competitive approaches to prevent cytomegalovirus (CMV) disease after renal transplantation. This trial compared efficacy, safety and long-term graft outcome in 148 renal graft recipients randomized to ganciclovir prophylaxis (N = 74) or preemptive therapy (N = 74). Hierarchical testing revealed (i) patients with CMV infection had more severe periods of impaired graft function (creatinine clearance(max-min) 25.0 +/- 14.2 mL/min vs. 18.1 +/- 12.5 mL/min for patients without CMV infection; p = 0.02),(ii) prophylaxis reduced CMV infection by 65% (13 vs. 33 patients; p < 0.0001) but (iii) creatinine clearance at 12 months was comparable for both regimes (54.0 +/- 24.9 vs. 53.1 +/- 23.7 mL/min; p = 0.92). No major safety issues were observed, and patient survival at 12 months was similar in both groups (5 deaths [6.8%] vs. 4 [5.4%], p = 1.0000). Prophylaxis significantly increased long-term graft survival 4 years posttransplant (92.2% vs. 78.3%; p = 0.0425) with a number needed to treat of 7.19. Patients with donor +/recipient + CMV serostatus had the lowest rate of graft loss following prophylaxis (0.0% vs. 26.8%; p = 0.0035). In conclusion, it appears that routine oral prophylaxis may improve long-term graft survival for most renal transplant patients. Preemptive therapy can be considered in low risk patients in combination with adequate CMV monitoring.
Kliem
V
V
Lower Saxony Center for Nephrology, Transplantation Center, Department of Nephrology, Vogelsang 105, D-34346 Hann. Muenden, Germany. v.kliem@awogsd.de
Fricke
L
L
Wollbrink
T
T
Burg
M
M
Radermacher
J
J
Rohde
F
F
D000998:Antiviral Agents / Q000627:therapeutic use; D003404:Creatinine / Q000378:metabolism; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000627:therapeutic use*; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D016030:Kidney Transplantation / Q000502:physiology*; D011183:Postoperative Complications / Q000517:prevention & control / Q000821:virology; D018401:Sample Size; D017211:Treatment Failure; D016896:Treatment Outcome
D000998:Antiviral Agents; D003404:Creatinine; D015774:Ganciclovir