BACKGROUND: Cytomegalovirus (CMV) infection is associated with reduced graft and patient survival among kidney recipients. The highest risk of CMV infection occurs in CMV-naive recipients of kidneys from seropositive donors (D+/R-). Optimal CMV prophylaxis is not established. This prospective cohort study compared the safety and efficacy of prophylaxis with 12 versus 24 weeks of oral ganciclovir. METHODS: We prospectively administered 24 weeks ganciclovir to 31 D+/R- recipients. The control group comprised 39 patients transplanted in the immediately preceding era who received a 12-week course of prophylaxis. All patients received cytolytic therapy within the first month, as well as a tacrolimus-based maintenance regimen. A logistic regression model was fit to examine the relationship between 24 weeks ganciclovir prophylaxis and the odds of developing CMV infection by one year. RESULTS: Groups were matched, though the 12-week cohort had more delayed graft function than their 24-week counterparts (45% vs. 29%, P=0.04). CMV infection occurred in 31% and 7% patients in the 12-week and 24-week groups, respectively (P<or=0.01). Mean time to development of CMV infection was 17.5+/-2.2 weeks in the 12-week, and 22.0+/-10.0 weeks in the 24-week, groups (P=0.79). Both 24 weeks ganciclovir prophylaxis (O.R. 0.15, 95% C.I. 0.03-0.91, P=0.04) and delayed graft function (O.R. 4.49, 95% C.I. 1.67-36.56, P<0.01) were associated with CMV infection. CONCLUSIONS: Oral ganciclovir prophylaxis for 24 weeks is associated with a lower risk of symptomatic CMV disease than a 12-week course in high risk D+/R- kidney recipients.
BACKGROUND:Cytomegalovirus (CMV) infection is associated with reduced graft and patient survival among kidney recipients. The highest risk of CMV infection occurs in CMV-naive recipients of kidneys from seropositive donors (D+/R-). Optimal CMV prophylaxis is not established. This prospective cohort study compared the safety and efficacy of prophylaxis with 12 versus 24 weeks of oral ganciclovir. METHODS: We prospectively administered 24 weeks ganciclovir to 31 D+/R- recipients. The control group comprised 39 patients transplanted in the immediately preceding era who received a 12-week course of prophylaxis. All patients received cytolytic therapy within the first month, as well as a tacrolimus-based maintenance regimen. A logistic regression model was fit to examine the relationship between 24 weeks ganciclovir prophylaxis and the odds of developing CMV infection by one year. RESULTS: Groups were matched, though the 12-week cohort had more delayed graft function than their 24-week counterparts (45% vs. 29%, P=0.04). CMV infection occurred in 31% and 7% patients in the 12-week and 24-week groups, respectively (P<or=0.01). Mean time to development of CMV infection was 17.5+/-2.2 weeks in the 12-week, and 22.0+/-10.0 weeks in the 24-week, groups (P=0.79). Both 24 weeks ganciclovir prophylaxis (O.R. 0.15, 95% C.I. 0.03-0.91, P=0.04) and delayed graft function (O.R. 4.49, 95% C.I. 1.67-36.56, P<0.01) were associated with CMV infection. CONCLUSIONS: Oral ganciclovir prophylaxis for 24 weeks is associated with a lower risk of symptomatic CMV disease than a 12-week course in high risk D+/R- kidney recipients.
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