A5101927057- Environmental and Ecological Studies
- Renal Transplantation Outcomes and Treatments
- Liver Disease Diagnosis and Treatment
- Business, Innovation, and Economy
- Transplantation: Methods and Outcomes
- Organ Transplantation Techniques and Outcomes
- Liver Disease and Transplantation
- Hepatitis C virus research
- Accounting and Financial Management
- Hepatitis B Virus Studies
- Science, Technology, and Education in Latin America
- Law, Ethics, and AI Impact
- Hepatocellular Carcinoma Treatment and Prognosis
- Geological and Tectonic Studies in Latin America
- Plant and soil sciences
- Water Resource Management and Quality
- Environmental and Cultural Studies in Latin America and Beyond
- Polyomavirus and related diseases
- Historical and socio-economic studies of Spain and related regions
- Spacecraft Design and Technology
- Regional Development and Innovation
- Higher Education and Sustainability
- Alcohol Consumption and Health Effects
- Knowledge Societies in the 21st Century
- Liver Diseases and Immunity
Novartis (Switzerland)
2014-2024
Mount Sinai Hospital
2022
Instituto de Investigación Biomédica de A Coruña
2022
Hospital de Clínicas
2005-2021
Universidad de la República de Uruguay
2021
Amgen (United States)
2019
Oslo University Hospital
2017
Universidad Nacional de Itapúa
2012
Kaohsiung Medical University
2009
Kaohsiung Medical University Chung-Ho Memorial Hospital
2009
In an open-label, 24-month trial, 721 <i>de novo</i> heart transplant recipients were randomized to everolimus 1.5 mg or 3.0 with reduced-dose cyclosporine, mycophenolate mofetil (MMF) 3 g/day standard-dose cyclosporine (plus corticosteroids ± induction). Primary efficacy endpoint was the 12-month composite incidence of biopsy-proven acute rejection, rejection associated hemodynamic compromise, graft loss/retransplant, death loss follow-up. Everolimus noninferior MMF for this at month 12...
The multimodal activities of farnesoid X receptor (FXR) agonists make this class an attractive option to treat nonalcoholic steatohepatitis. safety and efficacy tropifexor, FXR agonist, in a randomized, multicenter, double-blind, three-part adaptive design, phase 2 study, patients with steatohepatitis were therefore assessed. In Parts A + B, 198 randomized receive tropifexor (10-90 μg) or placebo for 12 weeks. Part C, 152 140 µg, 200 µg (1:1:1) 48 primary endpoints tolerability end-of-study,...
The impact of prolonged direct antiviral therapy on hepatitis B surface antigen (HBsAg) levels in patients with chronic is poorly understood. We quantitatively assessed serum HBsAg during 3 years telbivudine treatment, as well their relationship virologic and biochemical characteristics 162 e antigen–positive who maintained undetectable virus (HBV) DNA long-term. Telbivudine treatment progressively reduced (mean ± SD) from baseline (3.8 0.6 log10 IU/mL) to week 24 (3.4 0.7 IU/mL), year 1...
In a 24-month prospective, randomized, multicenter, open-label study, de novo liver transplant patients were randomized at 30 days to everolimus (EVR) + Reduced tacrolimus (TAC; n = 245), TAC Control (n 243) or Elimination 231). Randomization was stopped prematurely due significantly higher rate of treated biopsy-proven acute rejection (tBPAR). The incidence the primary efficacy endpoint, composite failure tBPAR, graft loss death postrandomization similar with EVR (10.3%) (12.5%) month 24...
There is a wide variation across studies in the reported prevalence of nonalcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH). A targeted literature review was conducted to understand NALFD NASH general population specific sub-populations as well identify risk factors associated with NASH. Embase Medline databases (2003–July 2018, English language) relevant conferences were searched observational meta-analysis reporting outcomes interest. Small cohort (<150 patients) wherein...
In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were at 10-14 weeks to convert everolimus (n = 359) or remain on standard calcineurin inhibitor (CNI) therapy 356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and steroids. The primary endpoint, change in estimated glomerular filtration rate (eGFR) from randomization month 12, was similar for versus CNI: mean (standard error) 0.3(1.5) mL/min/1.732 -1.5(1.5) (p 0.116)....
In a multicenter, open-label, study, 284 living-donor liver transplant patients were randomized at 30 ± 5 days posttransplant to start everolimus+reduced tacrolimus (EVR+rTAC) or continue standard (TAC Control). EVR+rTAC was non-inferior TAC Control for the primary efficacy endpoint of treated BPAR, graft loss death 12 months posttransplant: difference -0.7% (90% CI -5.2%, 3.7%); P < .001 non-inferiority. Treated BPAR occurred in 2.2% and 3.6% patients, respectively. The key secondary...
Background: In the GLOBE trial, telbivudine demonstrated superior efficacy to lamivudine at 2 years in patients with chronic hepatitis B (CHB). Aims: To investigate long-term and safety of telbivudine-treated cohort from trial. Methods: Virological biochemical responses were assessed 213 HBeAg-positive 186 HBeAg-negative CHB who continued treatment for 3 years. Results: Undetectable virus DNA HBeAg seroconversions achieved by 77 37% respectively. Cumulative seroconversion rate was 46%....
In Brief Background Mammalian target of rapamycin inhibitors may confer cardioprotective advantages, but clinical data are limited. Methods the open-label ELEVATE trial, kidney transplant patients were randomized at 10 to 14 weeks after convert from calcineurin inhibitor (CNI) everolimus or remain on standard CNI therapy. Prespecified end points included left ventricular mass index and, in a subpopulation patients, arterial stiffness as measured by pulse wave velocity. Results The mean...
In a 12-month, multicenter, open-label study, 106 children were randomized at 4 to 6 weeks after kidney transplantation switch everolimus with reduced TAC (EVR/rTAC) and steroid elimination from month 5 posttransplant or continue standard tacrolimus mycophenolate mofetil (sTAC/MMF) steroids. The cumulative incidence of co-primary efficacy end point (biopsy-proven acute rejection [BPAR], graft loss, death randomization 12) was 10.3% EVR/rTAC 5.8% sTAC/MMF (difference 4.4%; P = .417). BPAR...
Abstract In a 24‐month, multicenter, single‐arm, prospective study, 56 pediatric liver transplant patients with or without basiliximab induction were converted at 1‐6 months post‐transplant from standard calcineurin inhibitor (CN) therapy (± mycophenolic acid), to everolimus reduced exposure CNI (tacrolimus n=50, cyclosporine n=6). Steroid was optional. Recruitment stopped prematurely due high rates of PTLD, treatment‐related serious infections leading hospitalization and premature study...
A close temporal relationship between higher levels of portal pressure during the night and peak incidence acute variceal bleeding has recently been demonstrated in patients with cirrhosis. Because hemodynamic changes may have a role triggering this hemorrhagic episode, we measured systemic parameters at 4-hr intervals for 24 hr 12 cirrhotic patients. These results were compared those obtained eight healthy subjects. Cardiac output, femoral blood flows by Doppler technique. In patients,...
Robust clinical data evaluating fibrosis progression in hepatitis C virus (HCV) liver transplant patients receiving an mTOR inhibitor vs. calcineurin (CNI) are lacking. To evaluate maintenance everolimus- or CNI-based immunosuppression.In a randomised, multicentre, open-label study, 43 with recurrent HCV infection were randomised to continue immunosuppression switch everolimus.For biopsy at month 12, mean Ishak-Knodell score baseline was 2.6 ± 0.9 (n = 14) everolimus 1.9 1.1 18) CNI (P...
CRADLE was a 36-month multicenter study in pediatric (≥1 to <18 years) kidney transplant recipients randomized at 4 6 weeks posttransplant receive everolimus + reduced-exposure tacrolimus (EVR rTAC; n = 52) with corticosteroid withdrawal 6-month or continue mycophenolate mofetil standard-exposure TAC (MMF sTAC; 54) corticosteroids. The incidence of composite efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, death) month 36 9.8% vs 9.6% (difference: 0.2%; 80% confidence...
We characterized the early viral kinetic profiles of telbivudine and entecavir effects these potent nucleoside analogs on hepatitis B virus (HBV) DNA alanine aminotransferase levels in adults with e antigen-positive compensated chronic B. Forty-four patients were enrolled this open-label, parallel-group, multicenter study randomized to receive or for 12 weeks. Reductions from baseline weeks 2, 4, 8, assessed. Viral parameters, including clearance per day, loss infected cells efficiency...