Early Everolimus-Facilitated Reduced Tacrolimus in Liver Transplantation: Results From the Randomized HEPHAISTOS Trial.

Everolimus-facilitated reduced-exposure tacrolimus (EVR + rTAC) at 30 days after liver transplantation (LT) has shown advantages in renal preservation. This study evaluated the effects of early initiation of EVR + rTAC in de novo LT recipients (LTRs). In HEPHAISTOS (NCT01551212, EudraCT 2011-003118-17), a 12-month, multicenter, controlled study, LTRs were randomly assigned at 7 to 21 days after LT to receive EVR + rTAC or standard-exposure tacrolimus (sTAC) with steroids.

Frailty as a predictive factor for survival after liver transplantation, especially for patients with MELD≤15-a prospective study.

Introduction: Frailty has been discussed as a predictor of morbidity and mortality for liver cirrhosis. The aim of our study is to evaluate the role of frailty in liver transplantation, particularly for patients with MELD scores < 15.

Methods: All patients listed for liver transplantation between September 2015 and November 2018 were prospectively included in the study.

Inner Abdominal Fat and Psoas Muscle as Predictive Factors for the Outcome After Liver Transplant.

Objectives: We analyzed the nutritional condition of liver transplant recipients and the body mass index, the inner abdominal fat tissue, the outer abdominal fat tissue, the psoas muscle size, and the psoas muscle index of the recipients and evaluated the effects of these factors on patient outcomes after liver transplant.

Materials And Methods: We included recipients of liver transplants from January 2009 to December 2018 who had computed tomography at our center < 3 months before transplant. Preoperative, intraoperative, and postoperative data were evaluated.

mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors.

Objective: The aim of this study was to evaluate the survival benefit of sirolimus in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial).

Summary And Background Data: Patients receiving LT) for HCC are at a high risk for tumor recurrence. Calcineurin inhibitors have shown evidence to promote cancer growth, whereas mammalian target of rapamycin (mTOR) inhibitors like sirolimus have anticancer effects.

Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study.

Background: The 12-month (M) PROTECT study showed that 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. Here, we present the five-yr follow-up data.

Methods: PROTECT was a randomized controlled study in which LTxR received basiliximab and CNI-based immunosuppression ± corticosteroids.

Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial.

Background: We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC).

Methods: In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor-free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor-free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years.

Compliance and tolerability of subcutaneous hepatitis B immunoglobulin self-administration in liver transplant patients: a prospective, observational, multicenter study.

Background: Subcutaneous self-administration of hepatitis B immunoglobulin (HBIg) prophylaxis is preferred by patients, but compliance with the assigned regimen in routine practice is undocumented.

Material And Methods: A prospective, observational, 18-week, open-label, single-arm, multicenter study assessed compliance and tolerability in maintenance liver transplant patients self-administering subcutaneous HBIg at home according to local practice.

Results: Sixty-one patients were analyzed (median follow-up 18 weeks, range 14.

Diagnostic Dilemma in a Patient with Jaundice: How to Differentiate between Autoimmune Pancreatitis, Primary Sclerosing Cholangitis and Pancreas Carcinoma.

A 68-year-old male patient was referred to our institution in May 2011 for a suspected tumor in the pancreatic head with consecutive jaundice. Using magnetic resonance imaging, further differentiation between chronic inflammation and a malignant process was not possible with certainty. Apart from cholestasis, laboratory studies showed increased values for CA 19-9 to 532 U/ml (normal <37 U/ml) and hypergammaglobulinemia (immunoglobulin G, IgG) of 19.

Liver transplantation with donors over the expected lifespan in the model for end-staged liver disease era: is Mother Nature punishing us?

Background: The lack of sufficient donors to satisfy the waiting list requirements has prompted many to expand the acceptance criteria. The purpose of this study was to evaluate our liver transplantation (LT) experience with donors beyond the average lifespan.

Patients And Methods: From January 2008 to December 2009, we received 75 liver offers involving donors ≥ 75 years of age.

Efficacy, safety, and immunosuppressant adherence in stable liver transplant patients converted from a twice-daily tacrolimus-based regimen to once-daily tacrolimus extended-release formulation.

The aim of this study was to determine the efficacy, safety, and immunosuppressant adherence in 125 stable liver transplant (LT) patients converted from twice-daily tacrolimus (TAC BID) to once-daily TAC (TAC OD). Tacrolimus trough levels, laboratory parameters, metabolic disorders, selected patient reported outcomes, and adverse events were assessed. Mean TAC trough level concentration was 6.

Assessment of allograft fibrosis by transient elastography and noninvasive biomarker scoring systems in liver transplant patients.

Background: This prospective, monocentric study was designed to assess the efficacy of transient elastography (TE), biochemical tests, and more complex scores in determining fibrosis stage in 157 patients transplanted for hepatitis C virus (HCV) infection or non-HCV-related liver diseases.

Methods And Results: The optimal TE cutoff values for HCV patients and non-HCV patients were 4.7 and 5.

Pharmacokinetics of mycophenolic acid and its glucuronide metabolites in stable adult liver transplant recipients with renal dysfunction on a low-dose calcineurin inhibitor regimen and mycophenolate mofetil.

Low-dose calcineurin inhibitors (CNIs) in combination with a fixed dose (2 g/d) of mycophenolate mofetil (MMF) are a strategy to minimize exposure to cyclosporine (CSA) or tacrolimus (TAC) and thus reduce CNI-related side effects. This study compared the pharmacokinetics (PK) of mycophenolic acid (MPA) and its glucuronide metabolites in stable adult liver transplant recipients with moderately impaired renal function converted from a standard to a low-dose CNI regimen in combination with a fixed dose of MMF. Full 12-hour PK profiles of MPA, free MPA, the aryl glucuronide (MPAG), and the acyl glucuronide (AcMPAG) were obtained from 30 stable liver transplant patients on low-dose CNI (CSA, n = 12; TAC, n = 18) therapy at least 3 months after initiation of low-dose therapy.

Predictive factors of outcome in patients transplanted for hepatitis B.

Background: This study aimed to (1) identify the variables that affect graft and patient survival in recipients transplanted for hepatitis B virus (HBV) disease; and (2) assess factors associated with an increased risk of graft cirrhosis at 5 years after liver transplantation (LT).

Methods And Results: A total of 104 chronically infected HBV patients were considered for this study and all received tacrolimus- or cyclosporine A (CSA)-based immunosuppressive regimens. The overall 5-year patient and graft survival rates were 80% and 73%, respectively.