Safety and Efficacy of Early Everolimus in De Novo Orthotopic Liver Transplantation

M. Gastaca,¹ I. Bilbao,² M. Jimenez,³ J. Bustamente,¹ C. Dopazo,² R. Gonzalez,³ R. Charco,² J. Santoyo,⁴ J. Ortiz de Urbina.¹

¹Liver Transplantation Unit, Cruces University Hospital. University of the Basque Country, Bilbao, Vizcaya, Spain
²Hepatobiliopancreatic Surgery and Liver Transplant Unit, Hospital Universitario Vall d´Hebron, Barcelona, Spain
³Unidad de Hepatología-Trasplante Hepático, Hospital Regional Universitario de Malaga, Malaga, Spain
⁴Unidad de Cirugía Hepatobiliar-Trasplante Hepático, Hospital Regional Universitario de Malaga, Malaga, Spain.

Meeting: 2015 American Transplant Congress

Abstract number: A212

Keywords: Dyslipidemia, Immunosuppression, Neurotoxicity, Outcome

Session Information

Session Name: Poster Session A: Liver: Immunosuppression and Rejection

Session Type: Poster Session

Date: Saturday, May 2, 2015

Session Time: 5:30pm-7:30pm

Presentation Time: 5:30pm-7:30pm

Location: Exhibit Hall E

Purpose: To study the safety and efficacy of immunosuppression with Everolimus (EVL) within the first month after orthotopic liver transplantation.

Patients and methods: Recipients who had been treated with EVL within the first month after adult OLT were eligible to enter in a retrospective multicenter study. Patients were followed up for 12 months after OLT.

Results: From December 2006 to June 2014, 28 recipients entered in the study with a median age of 57.5 years (r 36-68). Primary disease leading to OLT was alcoholic cirrhosis in 12 patients, hepatitis C in 9 and both causes in 4. Median MELD score was 16 (r 7-40). Thirteen patients had hepatocellular carcinoma (HCC).

Everolimus was initiated at a median of 14 days (r 4-24) after OLT. The reason for early EVL was neurotoxicity in 14 cases, renal dysfunction in 12 and acute cellular rejection in 2. In 23 patients, immunosuppression was EVL+MMF/mycophenolate sodium +steroids while EVL+Tacrolimus+steroids/mycophenolate sodium was used in 4 cases.

All patients improved after initiation of EVL. Four patients (14.3%) developed acute cellular rejection. We observed 4 cases (14.3%) of incisional hernia, hematological complications in 6 patients (21.4%), proteinuria in 2 (7.1%), edema, ascites or pleural effusion in 8 (28.6%) and dyslipidemia in 12 patients (42.8%). Two patients suffered HCC recurrence. No arterial complications were observed. EVL was withdrawn in 4 patients during the first year after OLT due to proteinuria in 2 cases, wound dehiscence and medical decision in one case each. Two patients died during follow-up due to Hepatitis C and HCC recurrence in both cases. One year patient survival was 92.8%. Renal function evaluated using estimated glomerular filtration based on MDRD-4 formula in 12 patients with renal impairment improved from a median of 32 ml/min/1.73m² at the moment of initiation of EVL to 62 ml/min/1.73m² at 1 year.

Conclusion: Early use of EVL within the first month after OLT is effective and has an acceptable safety profile.

To cite this abstract in AMA style:

Gastaca M, Bilbao I, Jimenez M, Bustamente J, Dopazo C, Gonzalez R, Charco R, Santoyo J, Urbina JOrtizde. Safety and Efficacy of Early Everolimus in De Novo Orthotopic Liver Transplantation [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/safety-and-efficacy-of-early-everolimus-in-de-novo-orthotopic-liver-transplantation/. Accessed June 21, 2025.

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