Original Article
Copyright ©2014 Baishideng Publishing Group Inc. All rights reserved.
World J Transplant. Jun 24, 2014; 4(2): 122-132
Published online Jun 24, 2014. doi: 10.5500/wjt.v4.i2.122
Multiple indications for everolimus after liver transplantation in current clinical practice
Itxarone Bilbao, Cristina Dopazo, Jose Lazaro, Lluis Castells, Mireia Caralt, Gonzalo Sapisochin, Ramon Charco
Itxarone Bilbao, Cristina Dopazo, Jose Lazaro, Mireia Caralt, Gonzalo Sapisochin, Ramon Charco, Hepatobiliopancreatic Surgery and Liver Transplant Unit of the Department of General Surgery, Hospital Vall Hebrón, Universidad Autónoma Barcelona, 08035 Barcelona, Spain
Lluis Castells, Hepatology Unit of the Department of Internal Medicine, Hospital Vall Hebrón, Universidad Autónoma Barcelona, 08035 Barcelona, Spain
Itxarone Bilbao, Lluis Castells, Ramon Charco, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD o Ciberehd), Hospital Vall d´Hebron, 08035 Barcelona, Spain
Author contributions: Bilbao I, Castells L and Charco R contributed to study design and data analysis; Dopazo C, Lazaro J, Caralt M and Sapisochin G contributed to data collection; Bilbao I contributed to drafting of manuscript.
Correspondence to: Itxarone Bilbao, MD, PhD, Hepatobiliopancreatic Surgery and Liver Transplant Unit of the Department of General Surgery, Hospital Vall Hebrón, Universidad Autónoma Barcelona, Paseo Vall d´Hebron, 119-129, 08035 Barcelona, Spain. ibilbao@vhebron.net
Telephone: +34-93-2746113 Fax: +34-93-2746112
Received: February 23, 2014
Revised: April 14, 2014
Accepted: May 29, 2014
Published online: June 24, 2014
Processing time: 147 Days and 5.8 Hours
Abstract

AIM: To assess our experience with the use and management of everolimus-based regimens post-liver transplantation and to redefine the potential role of this drug in current clinical practice.

METHODS: From October 1988 to December 2012, 1023 liver transplantations were performed in 955 patients in our Unit. Seventy-four patients (7.74%) received immunosuppression with everolimus at some time post-transplantation. Demographic characteristics, everolimus indication, time elapsed from transplantation to the introduction of everolimus, doses and levels administered, efficacy, side effects, discontinuation and post-conversion survival were analyzed.

RESULTS: Mean age at the time of conversion to everolimus was 57.7 ± 10 years. Indications for conversion were: refractory rejection 31.1%, extended hepatocellular carcinoma in explanted liver 19%, post-transplant hepatocellular carcinoma recurrence 8.1%, de novo tumour 17.6%, renal insufficiency 8.1%, severe neurotoxicity 10.8%, and others 5.4%. Median time from transplantation to introduction of everolimus was 6 mo (range: 0.10-192). Mean follow-up post-conversion was 22 ± 19 mo (range: 0.50-74). The event for which the drug was indicated was resolved in 60.8% of patients, with the best results in cases of refractory rejection, renal insufficiency and neurotoxicity. Results in patients with cancer were similar to those of a historical cohort treated with other immunosuppressants. The main side effects were dyslipidemia and infections. Post-conversion acute rejection occurred in 14.9% of cases. The drug was discontinued in 28.4% of patients.

CONCLUSION: Everolimus at low doses in combination with tacrolimus is a safe immunosuppressant with multiple early and late indications post-liver transplantation.

Keywords: Everolimus; Liver transplantation; Indications; Off-protocol; Outcome

Core tip: Everolimus has a completely different mechanism of action to that of current basal calcineurine inhibitors used worldwide in liver transplantation. This immunosuppressant has a good profile for patients with pre- and post transplant renal dysfunction, one of the main concerns nowadays. It has also a promising role in cancer patients which is common in liver transplantation, either as an underlying disease (hepatocarcinoma in cirrhosis), or as de novo developing tumors. We present our off-protocol experience with partial/total and early/late conversion to everolimus, highlighting its efficacy and safety in fitting with the different emerging scenarios after liver transplantation.