Selective low-dose valganciclovir for prevention of cytomegalovirus disease following kidney transplantation.

Objectives: To assess the safety of a cytomegalovirus prophylaxis regimen using selective low-dose valganciclovir.

Methods: Retrospective before-after comparison, including consecutive kidney transplant recipients between 2002 and 2004. Excluded were deaths or graft loss within one month after transplantation. During the first period, universal prophylaxis with oral ganciclovir was used. During the second period, selective prophylaxis with low-dose valganciclovir (450 mg/day) was given to patients at high-risk for CMV disease (D+/R- recipients and patients treated with anti-lymphocyte antibodies) and oral acyclovir to all other patients. We compared the incidence of CMV disease between the two periods.

Results: Two hundred and sixty-four patients underwent kidney transplantation of which 221 were included. The incidence of CMV disease was higher with selective low-dose valganciclovir compared to universal ganciclovir without statistical significance, by intention to treat (4.7% vs. 8.5%, respectively, OR 1.88, 95% CI 0.63-5.60) and among patients adhering to the prophylaxis protocol (3.1% vs. 6.8% respectively, OR 2.85, 95% CI 0.65-12.38). Only late-onset CMV was observed for compliant patients. On multivariate analysis, only recipients' serostatus remained significantly associated with CMV disease (OR 0.22, 95% CI 0.07-0.70).

Conclusions: Selective low-dose valganciclovir may provide similar protection against CMV when compared to universal oral ganciclovir. Prolongation of prophylaxis beyond 100 days should be explored.