The impact of everolimus in reducing cytomegalovirus events in kidney transplant recipients on steroid‐avoidance strategy: 3‐year follow‐up of a randomized clinical trial

Summary There is no evidence of whether everolimus (EVR) reduces cytomegalovirus (CMV) events in patients receiving steroid‐free regimens. Besides, studies evaluating a tacrolimus (TAC) and EVR regimen are limited to 1‐year follow‐up. In this single‐center prospective randomized trial, the incidence of CMV and 3‐year efficacy and safety outcomes of EVR were compared to those of mycophenolate sodium (MPS) in a steroid‐free regimen based on low‐exposure TAC. Both groups received rabbit anti‐thymocyte globulin (r‐ATG) induction (6 mg/kg) and the steroids were withdrawn at day 7. Maintenance immunosuppression consisted of TAC (4–7 ng/ml until month 3 and 2–4 ng/ml thereafter) plus EVR (3–8 ng/ml) in the EVR group (n = 59); and TAC (4–7 ng/ml during all follow‐up) plus MPS (1440 mg) in the MPS group (n = 56). The EVR group presented with a lower incidence of CMV events (18.6% vs. 50%, P = 0.001). No differences were observed in biopsy‐proven acute rejection (6.8% vs. 3.6%, P = 0.680),graft loss (0.0% vs. 1.8%, P = 0.487),death (6.8% vs. 1.8%, P = 0.365), or estimated glomerular filtration rate at 36 months (61.1 ± 25.4 vs. 66.3 ± 24 ml/min/1.73 m2, P = 0.369). A higher proportion of patients discontinued MPS treatment (8.5% vs. 26.8%, P = 0.013) for safety issues. In conclusion, EVR was associated with lower rates of CMV events in patients induced with standard dose r‐ATG and a maintenance steroid‐free regimen based on TAC. This regimen effectively prevented acute rejection and demonstrated a more favorable safety profile. (ClinicalTrials.gov:NCT02084446).