Purpose: At the end of the 12-month (M) PROTECT core study (NCT00378014), de novo liver transplant recipients (LTxR) who switched from a calcineurin inhibitor (CNI) based immunosuppression to a CNI free everolimus (EVR) based regimen showed numerically better renal function. The renal function benefit with EVR group was maintained up to 3 years post LTx. Here we present the 5-year follow-up data from the PROTECT study. Methods: PROTECT was an open-label, parallel-group, randomized controlled study in which LTxR received basiliximab and CNI-based immunosuppression with/without corticosteroids. Between Week 4 and 8, patients were randomized 1:1 to receive EVR or continue CNI. In the EVR group, CNI was completely withdrawn after 8 weeks. Patients who completed core study were asked to enter the extension study and continue their randomized treatment. Key endpoints included change in renal function measured by estimated glomerular filtration rate (eGFR) by Cockcroft-Gault (CG), efficacy failure (composite of biopsy-proven acute rejection [BPAR], graft loss, death, or loss to follow-up), and incidence of adverse events (AEs) and serious AEs (SAEs). Results: A total of 81 patients entered the extension study (41, EVR group; 40, CNI group). At M59 post randomization, the adjusted mean eGFR was significantly higher in the EVR vs CNI group, with a benefit of 12.4 mL/min using CG [95%CI: 1.2; 23.6; P=0.0301]. In the extension period, 3 deaths occurred (EVR, 1; CNI, 2). There were no cases of graft loss. Two BPAR occurred in the EVR group. SAEs occurred in 26 (63.4%) and 28 (70.0%) of the patients in the EVR and CNI group, respectively. The most commonly reported AEs were incisional hernia, nasopharyngitis, peripheral edema, diarrhea, and back pain. Conclusion: In comparison to CNI based immunosuppressive treatment EVR-based CNI free immunosuppression resulted in better renal function and comparable patient and graft outcomes after 5 years follow-up.

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