CMV infection increases the morbidity, mortality, and costs of transplantation. We performed a randomized, prospective study to compare preemptive to deferred treatment of CMV infection in high-risk renal transplant pts. 36 CMV-seropositive renal allograft pts or seronegative pts of séropositive allografts who received anti-thymocyte induction immunesuppression were randomized at the time of transplantation to receive ganciclovir (5 mg/kg q 12 hours IV for 3 weeks) upon detection of viremia by PCR or buffy-coat culture (Preemptive Group; n=15) or identical treatment only after onset of a symptomatic CMVsyndrome (Deferred Group; n=21). Serology, shell vial culture, conventional culture, and PCR were obtained weekly for at least 12 weeks. Sensitivity of tile monitoring techniques, outcome, CMV and non-CMV charges were compared. Results: CMV viremia was detected in 94%. Sensitivity was 91%, 44%, and 47% for PCR, shell vial, and conventional culture, respectively. A delay in processing of the blood sample > 24 hrs reduced the sensitivity of culture to 1% but did not affect the PCR. 6 episodes of symptomatic CMV developed in the Preemptive Group: 2 with the initial detection of CMV and 4 others despite preemptive therapy. 13 episodes of symptomatic CMV occurred in the Deferred Group: 9 (43%) initial and 4 recurrences resulting in 1.2 vs 0.6 courses of ganciclovir per patient randomized; p=0.02. Retinitis developed in one pt treated preemptively, and pneumonitis in one patient in the Deferred Group. None of 5 CMV-seronegative pts of CMV-seropositive grafts developed invasive CMV disease. There were no differences in CMV or non-CMV related admissions or in-patient charges. Out-patient charges per patient randomized were higher in the Preemptive Group ($7,543 vs $2,322; p=0.0004). Pt and graft function and survival were similar. No pts died. Conclusions: The use of PCR to detect CMV infection in renal transplant pts is more sensitive than conventional monitoring. PCR monitoring and deferred treatment of CMV in high-risk renal transplant pts is more cost-effective than preemptive treatment. Both result in low CMV-associated morbidity and mortality.
|Journal||Journal of Investigative Medicine|
|State||Published - Jan 1 1996|