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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.

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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 1, 2025.

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