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55 results on '"Cynthia Levy"'

1. EASL Clinical Practice Guidelines on sclerosing cholangitis

Author

Olivier Chazouilleres, Ulrich Beuers, Annika Bergquist, Tom Hemming Karlsen, Cynthia Levy, Marianne Samyn, Christoph Schramm, Michael Trauner, Gastroenterology and Hepatology, Tytgat Institute for Liver and Intestinal Research, CCA - Cancer Treatment and Quality of Life, CCA - Cancer biology and immunology, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
Adult, Hepatology, Cholangitis, Sclerosing, Humans, Child, Prognosis
Abstract

Management of primary or secondary sclerosing cholangitis is challenging. These Clinical Practice Guidelines have been developed to provide practical guidance on debated topics including diagnostic methods, prognostic assessment, early detection of complications, optimal care pathways and therapeutic (pharmacological, endoscopic or surgical) options both in adults and children.

Published
2022
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2. A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis

Author

Christopher L. Bowlus, Michael R. Galambos, Richard J. Aspinall, Gideon M. Hirschfield, David E.J. Jones, Yvonne Dörffel, Stuart C. Gordon, Stephen A. Harrison, Andreas E. Kremer, Marlyn J. Mayo, Paul J. Thuluvath, Cynthia Levy, Mark G. Swain, Guy W. Neff, David A. Sheridan, Carmen M. Stanca, Christoph P. Berg, Aparna Goel, Mitchell L. Shiffman, John M. Vierling, Pol Boudes, Alexandra Steinberg, Yun-Jung Choi, and Charles A. McWherter

Subjects
Hepatology
Published
2022
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3. Proof-of-concept study to evaluate the safety and efficacy of saroglitazar in patients with primary biliary cholangitis

Author

Cynthia Levy, Deven Parmar, Andrew deLemos, Simona Rossi, Aasim Sheikh, Naga Chalasani, Nikolaos Pyrsopoulos, Edward Mena, David S. Goldberg, Stephen H. Caldwell, Farheen Shaikh, Ravi Ravinuthala, Raj Vuppalanchi, and James D. Bainbridge

Subjects
Male, Agonist, medicine.medical_specialty, medicine.drug_class, Placebo, Gastroenterology, Placebos, Double-Blind Method, Internal medicine, Humans, Medicine, Pyrroles, In patient, Phenylpropionates, Hepatology, Liver Cirrhosis, Biliary, business.industry, Incidence (epidemiology), Saroglitazar, Middle Aged, medicine.disease, Ursodeoxycholic acid, Treatment Outcome, Alkaline phosphatase, Female, business, Dyslipidemia, medicine.drug
Abstract

Saroglitazar is a novel peroxisome proliferator-activated receptor (PPAR) agonist with dual agonistic properties (α/γ). Due to a strong mechanistic rationale, we aimed to test the safety and efficacy of saroglitazar in patients with primary biliary cholangitis (PBC) who were either ursodeoxycholic acid (UDCA) resistant or intolerant.In this double-blind, phase II proof-of-concept trial, 37 patients with PBC were randomized to saroglitazar 4 mg (n = 13), saroglitazar 2 mg (n = 14), or placebo (n = 10) daily for 16 weeks. The primary efficacy endpoint was the reduction in alkaline phosphatase (ALP) level at Week 16.A significant reduction of mean ALP levels was observed at Week 16 relative to baseline in both the saroglitazar 4 mg (least-squares [LS] mean =-163.3 U/L, SE = 25.1, p0.001) and 2 mg (LS mean =-155.8 U/L, SE = 24.4, p0.001) groups, compared with placebo (LS mean =-21.1 U/L, SE = 28.9). Treatment with saroglitazar resulted in a rapid reduction of ALP concentration at Week 4 that was sustained through the study duration. At least 1 treatment-emergent adverse event occurred in 11 (84.6%) patients in the saroglitazar 4 mg group, in 12 (85.7%) patients in the 2 mg group and in 8 (80%) patients in the placebo group. Study drug was discontinued in 4 patients (3 patients in the 4 mg group and 1 patient in the 2 mg group) due to aminotransferase increases that promptly returned to baseline values after drug discontinuation.Saroglitazar at 2 mg and 4 mg daily was tolerated and resulted in rapid and sustained improvements in ALP. Further studies are underway at a daily dose of 2 mg and 1 mg due to the higher incidence of elevated liver enzymes observed with the 4 mg dose. CLINICALTRIALS.NCT03112681 LAY SUMMARY: Saroglitazar resulted in a rapid and sustained improvement in alkaline phosphatase levels in patients with primary biliary cholangitis. The mean percentage reductions in alkaline phosphatase levels were 49% and 51% in the saroglitazar 4 mg and 2 mg groups compared to 3% in the placebo group.

Published
2022
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7. Associations between novel serum biomarkers chitinase-2-like protein (YKL-40), type IV collagen, and thrombospondin-2 (TSP-2) with fibrosis stage and clinical outcomes in patients with primary sclerosing cholangitis (PSC)

Author

Michael Trauner, Andrew Muir, Jun Xu, Mina Khoshdeli, Bryan Downie, Andrew Billin, Chuhan Chung, Robert Myers, Zachary Goodman, Mitchell Shiffman, Harry Janssen, Aldo J Montano-Loza, Stephen Caldwell, Velimir Luketic, Michael P. Manns, Cynthia Levy, and Christopher Bowlus

Subjects
Hepatology
Published
2022
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8. A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA

Author

Kris V. Kowdley, Pascal Birman, S. Megnien, David Jones, Cynthia Levy, John M. Vierling, Gideon M. Hirschfield, Anne Tailleux, Velimir A. Luketic, Albert Parés, Michael A. Heneghan, Rémy Hanf, Alan Bonder, Bart Staels, David Magrez, Jörn M. Schattenberg, Stephen H. Caldwell, and Daniel Pratt

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Cirrhosis, Adolescent, Placebo-controlled study, Chronic liver disease, Placebo, Gastroenterology, law.invention, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Chalcones, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Clinical endpoint, Humans, PPAR alpha, PPAR delta, Aged, Hepatology, business.industry, Liver Cirrhosis, Biliary, Pruritus, Ursodeoxycholic Acid, Bilirubin, Middle Aged, medicine.disease, Alkaline Phosphatase, Ursodeoxycholic acid, Clinical trial, 030104 developmental biology, Treatment Outcome, Quality of Life, 030211 gastroenterology & hepatology, Female, Propionates, business, medicine.drug
Abstract

Patients with primary biliary cholangitis (PBC) who have an incomplete response to ursodeoxycholic acid remain at risk of disease progression. We investigated the safety and efficacy of elafibranor, a dual PPARα/δ agonist, in patients with PBC.This 12-week, double-blind phase II trial enrolled 45 adults with PBC who had incomplete response to ursodeoxycholic acid (alkaline phosphatase levels ≥1.67-fold the upper limit of normal (ULN). Patients were randomly assigned to elafibranor 80 mg, elafibranor 120 mg or placebo. The primary endpoint was the relative change of ALP at 12 weeks (NCT03124108).At 12 weeks, ALP was reduced by -48.3±14.8% in the elafibranor 80 mg group (p0.001 vs. placebo) and by -40.6±17.4% in the elafibranor 120 mg group (p0.001) compared to a +3.2±14.8% increase in the placebo group. The composite endpoint of ALP ≤1.67-fold the ULN, decrease of ALP15% and total bilirubin below the ULN was achieved in 67% patients in the elafibranor 80 mg group and 79% patients in the elafibranor 120 mg group, vs. 6.7% patients in the placebo group. Levels of gamma-glutamyltransferase decreased by 37.0±25.5% in the elafibranor 80 mg group (p0.001) and 40.0±24.1% in the elafibranor 120 mg group (p0.01) compared to no change (+0.2±26.0%) in the placebo group. Levels of disease markers such as IgM, 5'-nucleotidase or high-sensitivity C-reactive protein were likewise reduced by elafibranor. Pruritus was not induced or exacerbated by elafibranor and patients with pruritus at baseline reported less pruritic symptoms at the end of treatment. All possibly drug-related non-serious adverse events were mild to moderate.In this randomized phase II trial, elafibranor was generally safe and well tolerated and significantly reduced levels of ALP, composite endpoints of bilirubin and ALP, as well as other markers of disease activity in patients with PBC and an incomplete response to ursodeoxycholic acid.Patients with primary biliary cholangitis (a rare chronic liver disease) that do not respond to standard therapy remain at risk of disease progression toward cirrhosis and impaired quality of life. Elafibranor is a nuclear receptor agonist that we tested in a randomized clinical trial over 12 weeks. It successfully decreased levels of disease activity markers, including alkaline phosphatase. Thus, this study is the foundation for a larger prospective study that will determine the efficacy and safety of this drug as a second-line therapy.Clinical Trials.gov NCT03124108.

Published
2020

10. Machine learning models accurately interpret liver histology and are associated with disease progression in patients with primary sclerosing cholangitis

Author

Nate Travis, Vincent Billaut, Harsha Pokkalla, Kishalve Pethia, Oscar Zevallos, Benjamin Glass, Amaro Taylor, Christopher Bowlus, Atsushi Tanaka, Douglas Thorburn, Xiaomin Lu, Ryan Huss, Chuhan Chung, Mani Subramanian, Robert Myers, Andrew Muir, Kris V. Kowdley, Zachary Goodman, Aditya Khosla, Andrew Beck, Murray Resnick, Ilan Wapinski, Michael Trauner, and Cynthia Levy

Subjects
Hepatology
Published
2020
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15. GS-02-Efficacy of GKT831 in patients with primary biliary cholangitis and inadequate response to ursodeoxycholic acid: Interim efficacy results of a phase 2 clinical trial

Author

Lynsey Corless, Gerald Y. Minuk, John M. Vierling, Mark G. Swain, Marco Marzioni, Frederik Nevens, Tania M. Welzel, Philippe Wiese, Stephen A. Harrison, Gideon M. Hirschfield, Catherine Vincent, Carmen M. Stanca, Michael I. Miller, Douglas T. Dieterich, Michael A. Heneghan, Benedict Maliakkal, Raúl J. Andrade, Stefan Zeuzem, Grazia Anna Niro, Coral Hollywood, Anthony B. Post, Cynthia Levy, Pietro Invernizzi, Annarosa Floreani, Jonathan Huang, Christopher L. Bowlus, Luigi Muratori, Michal Cohen-Naftaly, Ella Veitsman, Christian Rupp, Marina G. Silveira, Yoav Lurie, Jane Collier, George V. Papatheodoridis, Elizabeth J. Carey, Brian B. Borg, Christophe Moreno, Van Vlierberghe Hans, Ehud Zigmond, Schattenberg JörnPD, David Romeo, George N. Dalekos, David Sheridan, P Spyridon Dourakis, Andreas E. Kremer, Mordechai Rabinovitz, Chin Lye Ch’ng, Ziv Ben Ari, David I. Bernstein, and Agustín Albillos

Subjects
medicine.medical_specialty, Hepatology, business.industry, Interim, Internal medicine, medicine, Phases of clinical research, In patient, business, Gastroenterology, Ursodeoxycholic acid, medicine.drug
Published
2019
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16. FRI-016-Validation of the PREsTo machine learning algorithm for the prediction of disease progression in patients with primary sclerosing cholangitis

Author

Xiaomin Lu, Konstantinos N. Lazaridis, Herold J. Metselaar, John E. Eaton, Bryan M. McCauley, Gideon M. Hirschfield, Cynthia Levy, Pietro Invernizzi, Brian D. Juran, Robert P. Myers, Andrew J. Muir, Chuhan Chung, Michael P. Manns, Zachary Goodman, Elizabeth J. Atkinson, Christopher L. Bowlus, Mani Subramanian, Henning Grønbæk, and Olivier Chazouillères

Subjects
medicine.medical_specialty, Hepatology, business.industry, Disease progression, medicine, In patient, Radiology, business, medicine.disease, Primary sclerosing cholangitis
Published
2019
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17. PS-016-Prospective evaluation of serum alkaline phosphatase variability and prognostic utility in primary sclerosing cholangitis using controlled clinical trial data

Author

Mani Subramanian, Zachary Goodman, Robert P. Myers, Andrew J. Muir, Gideon M. Hirschfield, Xiaomin Lu, Naga Chalasani, Christopher L. Bowlus, Michael P. Manns, Palak J. Trivedi, John M. Vierling, Cynthia Levy, Neil Guha, and Gerald Crans

Subjects
Clinical trial, medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Medicine, business, medicine.disease, Gastroenterology, Prospective evaluation, Serum alkaline phosphatase, Primary sclerosing cholangitis
Published
2019
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19. Treatment efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor delta agonist, in primary biliary cholangitis patients: 12- and 26-week analysis from an ongoing international, randomized, dose raging phase 2 study

Author

Bruce R. Bacon, Christopher L. Bowlus, Sandy P. Harrison, Robert C.G. Martin, Peter Buggisch, Mark G. Swain, David Sheridan, M.J. Mayo, Mitchell L. Shiffman, Pol Boudes, D.E.J. Jones, Tarek Hassanein, D. Thorburn, Y. Doerffel, Norman Gitlin, Alexandra Steinberg, Andreas E. Kremer, S. Bergheanu, Marcus-Alexander Wörns, Yun-Jung Choi, Brian B. Borg, G. Hirschfield, Joseph A. Odin, Mcwherter Charles A, Cynthia Levy, Richard Aspinall, S.C. Gordon, Lynsey Corless, M Varga, Paul J. Thuluvath, John M. Vierling, Galambos Michael, Christoph P. Berg, and Daniel Bernstein

Subjects
0301 basic medicine, Agonist, Hepatology, business.industry, medicine.drug_class, Phases of clinical research, Pharmacology, Treatment efficacy, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Medicine, 030211 gastroenterology & hepatology, Peroxisome proliferator-activated receptor delta, business
Published
2018
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20. PS-128-Risk of gall bladder cancer in patients with primary sclerosing cholangitis and gall bladder polyps: an opportunity to revisit the guidelines

Author

Harry L.A. Janssen, J.P.H. Drenth, Manasa Narasimman, Bettina E. Hansen, Morven Cunningham, Aliya Gulamhusein, Hamideh Aleali, Kartik S. Jhaveri, Liselot W van Erp, Gideon M. Hirschfield, and Cynthia Levy

Subjects
medicine.medical_specialty, Bladder cancer, Hepatology, business.industry, Internal medicine, medicine, Gall, In patient, medicine.disease, business, Gastroenterology, Primary sclerosing cholangitis, Bladder polyps
Published
2019
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21. FRI-037-Change in lipids: Characteristics and response to obeticholic acid in TARGET-PBC, a diverse, large United States real-world cohort

Author

Karen Deane, Cynthia Levy, Richard C. Zink, Marlyn J. Mayo, Robert Sandefur, Christopher L. Bowlus, W. Ray Kim, Ester C. Little, and Elizabeth J. Carey

Subjects
Oncology, medicine.medical_specialty, chemistry.chemical_compound, Hepatology, chemistry, business.industry, Internal medicine, Cohort, medicine, Obeticholic acid, business
Published
2019
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22. FRI-043-Primary biliary cholangitis-Autoimmune hepatitis overlap syndrome: Characteristics and response to obeticholic acid in TARGET-PBC, a diverse, large United States real-world cohort

Author

Richard C. Zink, Ester C. Little, Cynthia Levy, Elizabeth J. Carey, Robert Sandefur, Marlyn J. Mayo, W. Ray Kim, Karen Deane, and Christopher L. Bowlus

Subjects
medicine.medical_specialty, Hepatology, business.industry, Obeticholic acid, Overlap syndrome, Autoimmune hepatitis, medicine.disease, Gastroenterology, chemistry.chemical_compound, chemistry, Internal medicine, Cohort, medicine, business
Published
2019
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24. THU-024-Methylation signatures in blood show accelerated epigenetic aging in patients with primary sclerosing cholangitis compared to healthy controls

Author

Yevgeniy Gindin, Mani Subramanian, Chuhan Chung, Zhaoshi Jiang, Michael P. Manns, Robert P. Myers, Christopher L. Bowlus, Aliya Gulamhusein, Andrew J. Muir, Michael Trauner, Zachary Goodman, Cynthia Levy, and Kris V. Kowdley

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, medicine, In patient, Epigenetics, Methylation, medicine.disease, business, Gastroenterology, Primary sclerosing cholangitis
Published
2019
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25. LBO-02-Elafibranor, a peroxisome proliferator-activted receptor alpha and delta agonist demonstrates favourable efficacy and safety in patients with primary biliary cholangitis and inadequate response to ursodeoxycholic acid treatment

Author

David Magrez, PD Dr. Schattenberg Jörn, Rémy Hanf, John M. Vierling, S. Megnien, Stephen H. Caldwell, David Jones, MB Bchir, Cynthia Levy, Kris V. Kowdley, Velimir A. Luketic, Daniel Pratt, Pascal Birman, Albert Parés, Alan Bonder, Gideon M. Hirschfield, and Michael A. Heneghan

Subjects
Agonist, Hepatology, Peroxisome proliferator, medicine.drug_class, business.industry, Alpha (ethology), Elafibranor, Pharmacology, Ursodeoxycholic acid, medicine, In patient, business, Receptor, medicine.drug
Published
2019
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26. Safety, efficacy and tolerability of half-dose sofosbuvir plus simeprevir in treatment of Hepatitis C in patients with end stage renal disease

Author

Kalyan Ram, Bhamidimarri, Bhamidimarri, Kalyan Ram, Frank, Czul, Czul, Frank, Adam, Peyton, Peyton, Adam, Cynthia, Levy, Levy, Cynthia, Maria, Hernandez, Hernandez, Maria, Lennox, Jeffers, Jeffers, Lennox, David, Roth, Roth, David, Eugene, Schiff, Schiff, Eugene, Christopher, O'Brien, O'Brien, Christopher, Paul, Martin, and Martin, Paul

Subjects
Adult, Male, Simeprevir, medicine.medical_specialty, Sofosbuvir, Antiviral Agents, Gastroenterology, End stage renal disease, Internal medicine, medicine, Humans, In patient, Aged, Hepatology, business.industry, Hepatitis C, Middle Aged, medicine.disease, Tolerability, Kidney Failure, Chronic, Drug Therapy, Combination, Female, business, medicine.drug
Published
2015
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27. Prospective validation of serum alkaline phosphatase for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis

Author

Christopher L. Bowlus, Mani Subramanian, M.P. Manns, Aldo J. Montano-Loza, B. Mccolgan, Catherine Jia, R. Myers, H.L.A. Janssen, John G. McHutchison, Gideon M. Hirschfield, Bertus Eksteen, D. Ding, Mitchell L. Shiffman, Zachary Goodman, Roger W. Chapman, Andrew J. Muir, and Cynthia Levy

Subjects
0301 basic medicine, medicine.medical_specialty, Pathology, Hepatology, business.industry, Disease progression, medicine.disease, Gastroenterology, law.invention, Primary sclerosing cholangitis, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, 030211 gastroenterology & hepatology, business, Serum alkaline phosphatase
Published
2017
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28. Common variation near glial-derived neurotrophic factor is associated with progression of hepatic collagen content in a genome-wide association study of liver fibrosis phenotypes in patients with primary sclerosing cholangitis

Author

Cynthia Levy, B. Mccolgan, Patrick R. Shea, M.P. Manns, Mani Subramanian, Aldo J. Montano-Loza, Andrew J. Muir, Zachary Goodman, Sarah E. Kleinstein, Roger W. Chapman, Mitchell L. Shiffman, H.L.A. Janssen, Gideon M. Hirschfield, John G. McHutchison, Christopher L. Bowlus, David Goldstein, Bertus Eksteen, and R. Myers

Subjects
Pathology, medicine.medical_specialty, Hepatology, biology, Liver fibrosis, Genome-wide association study, medicine.disease, Phenotype, Primary sclerosing cholangitis, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Glial cell line-derived neurotrophic factor, biology.protein, medicine, 030211 gastroenterology & hepatology, In patient
Published
2017
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29. Prospective evaluation of serum gamma-glutamyl transferase (GGT) for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis (PSC)

Author

B. Mccolgan, Gideon M. Hirschfield, Bertus Eksteen, Mitchell L. Shiffman, D. Ding, H.L.A. Janssen, M.P. Manns, Andrew J. Muir, Aldo J. Montano-Loza, Zachary Goodman, Roger W. Chapman, Stephen H. Caldwell, R. Myers, Velimir A. Luketic, Christopher L. Bowlus, and Cynthia Levy

Subjects
medicine.medical_specialty, Hepatology, business.industry, Disease progression, medicine.disease, Gastroenterology, Prospective evaluation, law.invention, Primary sclerosing cholangitis, Gamma glutamyl transferase, Randomized controlled trial, law, Internal medicine, medicine, business
Published
2018
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31. Pharmacokinetics and pharmacodynamics of seladelpar, a potent and selective PPAR-delta, in patients with primary biliary cholangitis

Author

John M. Vierling, Mitchell L. Shiffman, Christopher L. Bowlus, M Varga, Robert C.G. Martin, Paul J. Thuluvath, Stephen A. Harrison, G. Hirschfield, Joseph A. Odin, Cynthia Levy, Galambos Michael, Yun-Jung Choi, Norman Gitlin, Mcwherter Charles A, Tarek Hassanein, Pol Boudes, D. Thorburn, D.E.J. Jones, Alexandra Steinberg, and David Sheridan

Subjects
Primary (chemistry), Hepatology, Pharmacokinetics, business.industry, Medicine, Peroxisome proliferator-activated receptor delta, In patient, Pharmacology, business
Published
2018
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32. Real world evidence showing high rates of cardiovascular events in NAFLD patients regardless of liver disease

Author

Cheryl Schoen, L.M. Weiss, Arun J. Sanyal, Rajender Reddy, Anna S.F. Lok, Norman Gitlin, Kenneth Cusi, Cynthia Levy, Roberto J. Firpi, and Laura Malahias

Subjects
High rate, medicine.medical_specialty, Liver disease, Hepatology, business.industry, Internal medicine, medicine, Real world evidence, business, medicine.disease, Gastroenterology
Published
2018
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33. Correlations between Hepatic Morphometric Collagen Content, Histologic Fibrosis Stage, and Serum Markers in Patients with Primary Sclerosing Cholangitis (PSC)

Author

Christopher L. Bowlus, R. Aguilar, Cynthia Levy, L. Alaparthi, R. Myers, Kushang V. Patel, Andrew J. Muir, John G. McHutchison, M.P. Manns, G.M. Subramanian, Indra Neil Guha, Bilal Hameed, Kris V. Kowdley, Zachary Goodman, Roger W. Chapman, and F. Monge

Subjects
Pathology, medicine.medical_specialty, Hepatology, business.industry, medicine, In patient, Fibrosis stage, medicine.disease, business, Primary sclerosing cholangitis, Serum markers
Published
2016
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34. Renal Function Decline is Frequent in Patients Undergoing Hepatitis C Treatment Post Kidney Transplant

Author

Paul L. Martin, Kalyan Ram Bhamidimarri, Cynthia Levy, and David Roth

Subjects
0301 basic medicine, Nephrology, medicine.medical_specialty, Hepatology, business.industry, Renal function, Hepatitis C, medicine.disease, Gastroenterology, Kidney transplant, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Internal medicine, medicine, 030211 gastroenterology & hepatology, In patient, business
Published
2016
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36. Genome-Wide Association Study (Gwas) of Liver Fibrosis Phenotypes in Patients with Primary Sclerosing Cholangitis (Psc) Reveals Common Genetic Variation Influencing Serum Levels of Lysyl Oxidase-Like-2 (Loxl2)

Author

H.L.A. Janssen, M.P. Manns, Gideon M. Hirschfield, M.L. Shiftman, Zachary Goodman, Roger W. Chapman, Andrew J. Muir, Christopher L. Bowlus, Aldo J. Montano-Loza, R. Myers, Sarah E. Kleinstein, Cynthia Levy, Patrick R. Shea, David Goldstein, Bertus Eksteen, G.M. Subramanian, and John G. McHutchison

Subjects
Hepatology, LOXL2, Liver fibrosis, Genetic variation, Immunology, medicine, Genome-wide association study, In patient, Lysyl oxidase, Biology, medicine.disease, Phenotype, Primary sclerosing cholangitis
Published
2016
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37. Current management of primary biliary cirrhosis and primary sclerosing cholangitis

Author

Keith D. Lindor and Cynthia Levy

Subjects
education.field_of_study, medicine.medical_specialty, Hepatology, Liver Cirrhosis, Biliary, business.industry, Biliary cirrhosis, Cholangitis, Sclerosing, Population, Disease, Jaundice, medicine.disease, Asymptomatic, Primary sclerosing cholangitis, Primary biliary cirrhosis, Internal medicine, Etiology, Humans, Medicine, medicine.symptom, business, education
Abstract

Primary biliary cirrhosis (PBC) is a chronic, cholestatic autoimmune liver disease characterized by inflammation and progressive destruction of interlobular bile ducts, ultimately leading to biliary cirrhosis. Population based studies have estimated the incidence of PBC as 19.1–251/ 1 000 000 in the general population [1,2]. The etiology of PBC is attributed to autoimmunity mainly due to the association with antimitochondrial antibodies, present in 95% of PBC patients, but genetic and environmental factors are thought to contribute as well. In a large epidemiologic study conducted in the United States a survey was sent to 241 patients with PBC using standardized questions drawn from the National Health and Nutrition Examination Survey in an attempt to identify risk factors for the disease; 83.3% of the patients returned the questionnaires [3]. Surveys were also sent to siblings and friends of the cases. The female -to-male ratio among cases was 10:1, and the mean age of respondents was 53 years, accurately reflecting the general knowledge on epidemiology of PBC. The investigators identified that autoimmune diseases (Sjogren’s syndrome, Raynaud’s syndrome, autoimmune thyroid disease) were 3–15 times more frequent among PBC cases than their siblings or cases and there was a 6% prevalence of PBC in first degree relatives of cases. In addition, several illnesses were seen in association with PBC, such as urinary tract infection, tonsillectomy, cholecystectomy and shingles, raising the possibility that an infectious agent may also be involved in the pathogenesis of PBC. Symptoms begin insidiously. Fatigue is the most common symptom, present in up to 70% of patients [4], followed by pruritus, which can be quite distressing for the patient. Jaundice develops later, usually associated with progression of the disease. Other symptoms are related to portal hypertension and other sequelae of advanced cholestatic liver disease. There are several prognostic models for predicting survival, with the serum bilirubin level being the only variable common to all of them. The prognosis is noticeably different for asymptomatic or symptomatic patients, but it is clearly documented that even asymptomatic patients have a shorter survival compared to the general population [5]. The overall survival rate ranged from 5.5 to 11.9 years in the pre-transplant era [6]. A Kaplan–Meier graphic of the estimated survival in PBC is shown in Fig. 1. Therapy is aimed at preventing disease progression as well as treating or preventing its complications, namely osteoporosis, fat-soluble vitamin deficiencies, pruritus and portal hypertension.

Published
2003
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38. Efficacy and safety of simtuzumab for the treatment of primary sclerosing cholangitis: results of a phase 2b, dose-ranging, randomized, placebo-controlled trial

Author

B. Mccolgan, M.P. Manns, Nezam H. Afdhal, Cynthia Levy, R. Myers, Aldo J. Montano-Loza, Zachary Goodman, Roger W. Chapman, John G. McHutchison, H.L.A. Janssen, Andrew J. Muir, Bertus Eksteen, D. Ding, Mani Subramanian, Catherine Jia, and Christopher L. Bowlus

Subjects
medicine.medical_specialty, Hepatology, business.industry, Placebo-controlled study, medicine.disease, Gastroenterology, Primary sclerosing cholangitis, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, medicine, 030211 gastroenterology & hepatology, business
Published
2017
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39. Serum fibroblast growth factor 19, 7α-Hydroxy-4-Cholesten-3-one, and bile acids and their associations with clinical characteristics in primary sclerosing cholangitis

Author

Paul J. Pockros, Andrew J. Muir, Velimir A. Luketic, G. Y. Minuk, Stephen H. Caldwell, Mitchell L. Shiffman, A. Billin, Mani Subramanian, B. Mccolgan, Bertus Eksteen, S. Djedjos, R. Myers, Cynthia Levy, Zachary Goodman, Pietro Invernizzi, Christopher L. Bowlus, and D. Ding

Subjects
chemistry.chemical_compound, medicine.medical_specialty, Hepatology, chemistry, 7α-Hydroxy-4-cholesten-3-one, Internal medicine, medicine, Fibroblast growth factor, medicine.disease, Gastroenterology, Primary sclerosing cholangitis
Published
2017
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40. Prospective validation of the Enhanced Liver Fibrosis test for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis

Author

Christopher L. Bowlus, Mani Subramanian, Kushang V. Patel, B. Mccolgan, Gideon M. Hirschfield, D. Ding, John G. McHutchison, Zachary Goodman, Roger W. Chapman, Andrew J. Muir, R. Myers, William Rosenberg, Cynthia Levy, Catherine Jia, Olivier Chazouillères, and Indra Neil Guha

Subjects
medicine.medical_specialty, Hepatology, business.industry, Liver fibrosis, Disease progression, medicine.disease, Gastroenterology, Primary sclerosing cholangitis, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030220 oncology & carcinogenesis, Internal medicine, medicine, 030211 gastroenterology & hepatology, business
Published
2017
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41. P0878 : First ribavirin-free sofosbuvir and simeprevir treatment of Hepatitis C genotype 1 patients with severe renal impairment (GFR <30 ml/min or dialysis)

Author

Christopher B. O'Brien, Maria D. Hernandez, Eugene R. Schiff, Paul J. Martin, Kalyan Ram Bhamidimarri, Cynthia Levy, Jeffers Lj, Frank Czul, and Adam Peyton

Subjects
Simeprevir, medicine.medical_specialty, Hepatology, Sofosbuvir, business.industry, Ribavirin, medicine.medical_treatment, Hepatitis C, medicine.disease, Gastroenterology, chemistry.chemical_compound, chemistry, Internal medicine, Genotype, Medicine, business, Intensive care medicine, Dialysis, medicine.drug
Published
2015
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42. Serum LYSYL Oxidase-Like-2 (SLOXL2) Levels Correlate with Disease Severity in Patients with Primary Sclerosing Cholangitis

Author

Andrew J. Muir, Gideon M. Hirschfield, G.M. Subramanian, D. Ding, Christopher L. Bowlus, R. Aguilar, John G. McHutchison, Pietro Invernizzi, Velimir A. Luketic, Bertus Eksteen, Gerald Y. Minuk, R. Myers, Cynthia Levy, Zachary Goodman, and Stephen H. Caldwell

Subjects
medicine.medical_specialty, Hepatology, business.industry, 05 social sciences, Lysyl oxidase, medicine.disease, Gastroenterology, Primary sclerosing cholangitis, 03 medical and health sciences, 0302 clinical medicine, Disease severity, Internal medicine, 0502 economics and business, medicine, 050211 marketing, 030211 gastroenterology & hepatology, In patient, business
Published
2016
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43. Impact of Gender on Clinical Presentation, Response to Treatment, and Long-Term Outcomes in an Ethnically Diverse Population of Patients with Autoimmune Hepatitis

Author

Jean A. Donet, Kalyan Ram Bhamidimarri, Dani Gilinsky, Cynthia Levy, Erin Perlini, and Michael Huang

Subjects
Pediatrics, medicine.medical_specialty, education.field_of_study, Hepatology, business.industry, media_common.quotation_subject, Population, Autoimmune hepatitis, Ethnically diverse, medicine.disease, Response to treatment, Presentation, Immunology, Long term outcomes, medicine, education, business, media_common
Published
2016
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44. Clarity: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Lopixibat Chloride (Formerly Lum001), a Novel Apical Sodium-Dependent Bile Acid Transporter Inhibitor, in the Treatment of Primary Biliary Cirrhosis Associated with Itching

Author

Raj Vuppalanchi, A. Raychaudhuri, Gideon M. Hirschfield, Velimir A. Luketic, Bruce R. Bacon, M.J. Mayo, Alejandro Dorenbaum, Sharon Medendorp, Ciara Kennedy, I Patanwala, Cynthia Levy, S. Goyal, Christopher L. Bowlus, W. Abi-Saab, P. Novak, Paul J. Pockros, and D.E.J. Jones

Subjects
medicine.medical_specialty, Hepatology, business.industry, Apical sodium-dependent bile acid transporter, Placebo-controlled study, medicine.disease, Chloride, Gastroenterology, Double blind, 03 medical and health sciences, 0302 clinical medicine, Primary biliary cirrhosis, 030220 oncology & carcinogenesis, Internal medicine, medicine, Itching, 030211 gastroenterology & hepatology, medicine.symptom, business, medicine.drug
Published
2016
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45. P367 PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF USTEKINUMAB IN PATIENTS WITH PRIMARY BILIARY CIRRHOSIS WHO HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID

Author

Hanns-Ulrich Marschall, G. Hirschfield, Cynthia Levy, M. E. Gershwin, R. Strauss, Keith D. Lindor, M.J. Mayo, B. Zou, and Carlo Selmi

Subjects
medicine.medical_specialty, Hepatology, business.industry, Phases of clinical research, medicine.disease, Gastroenterology, Ursodeoxycholic acid, Primary biliary cirrhosis, Internal medicine, Ustekinumab, Medicine, In patient, business, medicine.drug
Published
2014
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46. Corrigendum to 'Safety, efficacy and tolerability of half-dose sofosbuvir plus simeprevir in treatment of Hepatitis C in patients with end stage renal disease' [J Hepatol 2015;63:763–765]

Author

Adam Peyton, Eugene R. Schiff, Kalyan Ram Bhamidimarri, Frank Czul, Cynthia Levy, Christopher B. O'Brien, Paul J. Martin, David Roth, Lennox J. Jeffers, and Maria D. Hernandez

Subjects
Simeprevir, Nephrology, medicine.medical_specialty, Hepatology, Sofosbuvir, business.industry, Hepatitis C, Pharmacology, medicine.disease, End stage renal disease, Tolerability, Internal medicine, medicine, In patient, business, medicine.drug
Abstract

Corrigendum to ‘‘Safety, efficacy and tolerability of half-dose sofosbuvir plus simeprevir in treatment of Hepatitis C in patients with end stage renal disease” [J Hepatol 2015;63:763–765] Kalyan Ram Bhamidimarri, Frank Czul1,⇑, Adam Peyton, Cynthia Levy, Maria Hernandez, Lennox Jeffers, David Roth, Eugene Schiff, Christopher O’Brien, Paul Martin University of Miami, Division of Medicine, Department of Hepatology, United States; University of Miami, Division of Medicine, Department of Nephrology, United States

Published
2015
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47. 1400 DISCOVERY OF A DIRECT ASSOCIATION BETWEEN PRIMARY BILIARY CIRRHOSIS AND LOW BONE MASS: IDENTIFICATION OF TNFSF11/RANKL AS A RISK LOCUS FOR PATIENTS WITH PBC

Author

Vito Annese, Maurizio Marconi, Joseph A. Odin, Landon L. Chan, Konstantinos N. Lazaridis, Catherine Vincent, Valentina Liakina, Daniele Cusi, Yafang Li, Christopher I. Amos, Erik M. Schlicht, R. Shigetta, Andre Franke, Velimir A. Luketic, Michael F. Seldin, Piotr Milkiewicz, Roman Kosoy, Craig Lammert, Pietro Invernizzi, M. de Andrade, P.K. Gregerson, Brian D. Juran, Yan V. Sun, Kathy Siminovitch, Gang Xie, Michael Ransom, Cynthia Levy, M. E. Gershwin, Andrew Mason, Ilaria Bianchi, Ana Lleo, Elizabeth J. Atkinson, Henry C. Bodenheimer, Francesca Bernuzzi, Catalina Coltescu, Tobias Balschun, Robert P. Myers, Gideon M. Hirschfield, and Bruce R. Bacon

Subjects
medicine.medical_specialty, Hepatology, biology, business.industry, Low bone mass, Locus (genetics), medicine.disease, Gastroenterology, Primary biliary cirrhosis, RANKL, Internal medicine, biology.protein, Medicine, business
Published
2012
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49. 1 THE NATURAL HISTORY OF HCV-RELATED CIRRHOSIS AFTER LIVER TRANSPLANTATION

Author

Roberto J. Firpi, Giuseppe Morelli, Roniel Cabrera, Virginia Clark, David R. Nelson, Consuelo Soldevila-Pico, C. Chen, Victor I. Machicao, and Cynthia Levy

Subjects
Natural history, medicine.medical_specialty, Cirrhosis, Hepatology, business.industry, Internal medicine, medicine.medical_treatment, medicine, Liver transplantation, medicine.disease, business, Gastroenterology
Published
2008
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