Introduction.

Aim of this study was to evaluate the efficacy and safety of preemptive prophylaxis of CMV infection in kidney transplant recipients (KTx) receiving polyclonal antibodies induction and randomized to an immunosuppressive regimen with/without Everolimus (EVE).

Methods.

Two-hundred-and-five KTx were randomized (2:1) to maintenance immunosuppressive therapy based on Calcineurin Inhibitors (CNIs) in combination with MMF (128 pts, MMF) or Everolimus (77 pts, EVE). All KTx received induction with Thymoglobulin (total median dose 200 mg). We monitored PCR CMV DNA in whole blood every 2 weeks in the first 3 months after transplantation, then monthly until the first year and therafter every 3 months. When PCR CMV DNA was found positive we started valganciclovir and the treatment was continued until at least 3 negative PCR CMV DNA results were obtained.

Results.

At 6 months follow-up 84/205 (41%) pts become CMV-PCR positive without any other symptomatology, 11/205 pts (4,9%) had CMV syndrome. Between 6 and 36 months (median follow-up) other 6/205 (2.9%) pts become CMV-PCR positive, without any other symptomatology, 2/205 (0.9%) pts had CMV syndrome and 2/205 (0.9%) pts had mild CMV pneumonitis. Median time for CMV-PCR positivity finding was 36 days after transplantation. Patients receiving Everolimus showed significantly lower CMV-PCR positivity: EVE 36% vs MMF 64%, p<0.001. CMV syndrome was not significantly different in patients receiving Everolimus or MMF (6 pts vs 7 pts, p=ns). Median viral load CMV-PCR was 4.446 copies/ml, lower in the EVE group but not significantly different. We then looked at the positive patients divided in categories based on the number of copies of replication. The majority of pts had less than 5.000 copies of PCR-CMV-DNA and the percentage of positive pts for every number of copies of replication was lower in the Everolimus group.

Conclusions.

Our data suggest that in KTx receiving induction therapy with Thymoglobulin, Everolimus significantly reduces the CMV infection, within a preemptive strategy of CMV disease prophylaxis. Further studies are required to indicate the optimal number of copies to start the preemptive therapy for CMV infection in KTx.

CITATION INFORMATION: Spagnoletti G, Salerno M, Bianchi V, Silvestrini N, Apponi F, Romagnoli J. Preemptive CMV Prophylaxis in Renal Transplant Recipients Receiving Everolimus Immunosuppression Reduces Cytomegalovirus Infection. Am J Transplant. 2016;16 (suppl 3).

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