Purpose: Post-transplant (Tx) bacterial and viral infections are known to affect graft and patient survival. Accumulating evidence supports the protective effect of everolimus (EVR) against viral infections, especially cytomegalovirus (CMV) infections, in kidney transplant recipients (KTxRs). Here, we report 12 months (M) results on the incidence of infections in KTxRs receiving EVR+reduced calcineurin inhibitor (rCNI) vs mycophenolic acid (MPA)+standard CNI (sCNI) regimen from the TRANSFORM study.

Methods: TRANSFORM (NCT01950819) is a 24M, multicenter, open-label, two-arm study in which de novo KTxRs were randomized (1:1) within 24 h post-Tx to receive either EVR+rCNI (N=1022) or MPA+sCNI (N=1015), with induction and steroids. Viral (CMV and BKV) and bacterial infection rates were assessed by treatment and/or serology type.

Results: The overall infection rate was lower with EVR+rCNI than MPA+sCNI regimen (52.0% vs 59.8%). EVR+rCNI regimen also showed lower incidence of viral (17.2% vs 29.2%, P<0.001) and bacterial infections (34.8% vs 37.6%) than MPA+sCNI. The overall incidence of CMV infections was significantly lower with EVR+rCNI vs MPA+sCNI regimen (3.6% vs 13.3%, P<0.001). Though baseline CMV status was comparable between arms, CMV incidence was significantly lower in EVR+rCNI vs MPA+sCNI arm among high risk patients with serology status D+/R+ (7.6% vs 23.3%, P<0.0001) and D+/R−(16.6% vs 35.5%, P = 0.0004) (Table). The overall rates of BKV infection reported as adverse event were also significantly lower in EVR+rCNI vs MPA+sCNI arm (4.3% vs 8.0%, P<0.001).

Conclusions: M12 results from TRANSFORM, the largest KTx study to date, confirmed the benefit of early EVR introduction in preventing viral infection in de novo KTxRs. The 24M results are awaited and will further confirm these benefits.

CITATION INFORMATION: Vincenti F., Cruzado J., Mulgaonkar S., Garcia V., Kuypers D., Buchler M., Citterio F., Huynh-Do U., Luo W-.L., Bernhardt P., Sommerer C. The TRANSFORM Study: Infection Outcomes with Everolimus Plus Reduced Calcineurin Inhibitor and Mycophenolate Plus Standard Calcineurin Inhibitor Regimens in De Novo Kidney Transplant Recipients Am J Transplant. 2017;17 (suppl 3).

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