| Original language | English (US) |
|---|---|
| Pages (from-to) | 422-427.e1 |
| Journal | Gastroenterology |
| Volume | 159 |
| Issue number | 2 |
| DOIs | |
| State | Published - Aug 2020 |
ASJC Scopus subject areas
- Hepatology
- Gastroenterology
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In: Gastroenterology, Vol. 159, No. 2, 08.2020, p. 422-427.e1.
Research output: Contribution to journal › Editorial › peer-review
}
TY - JOUR
T1 - Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility
T2 - Recommendations From the Multi-stakeholder Liver Forum
AU - Liver Forum NASH Cirrhosis Working Group
AU - Noureddin, Mazen
AU - Chan, Jean L.
AU - Barradas, Katherine
AU - Dimick-Santos, Lara
AU - Schabel, Elmer
AU - Omokaro, Stephanie O.
AU - Anania, Frank A.
AU - Myers, Robert P.
AU - Miller, Veronica
AU - Sanyal, Arun J.
AU - Chalasani, Naga
AU - Bajaj, Jasmohan
AU - Berzigotti, Annalisa
AU - Birman, Pascal
AU - Bosch, Jaime
AU - Brower, Ashley
AU - Calboli, Dania
AU - Charlton, William
AU - Dickinson, Klara
AU - Filozof, Claudia
AU - Forsgren, Mikael F.
AU - Fuchs, Michael
AU - Garcia-Tsao, Guadalupe
AU - Gonzalez-Abraldes, Juan
AU - Gruss, Hans Juergen
AU - Hansen, Morten
AU - Hosman, Suneil
AU - Imperial, Joanne
AU - Jones, David
AU - Lalazar, Gadi
AU - Leinhard, Olof Dahlqvist
AU - Lyons, Erica
AU - McColgan, Brian
AU - Mehta, Ruby
AU - Mesenbrink, Peter
AU - Myers, Rob
AU - Pei, Veronica
AU - Ratziu, Vlad
AU - Regev, Arie
AU - Riccio, Robert
AU - Sanyal, Arun
AU - Seo, Suna
AU - Smith, Alastair
AU - Szitanyi, Peter
AU - Traber, Peter
N1 - Funding Information: Conflicts of interest The authors have made the following disclosures: Naga Chalasani has ongoing consulting activities (or had in preceding 12 months) with NuSirt, Abbvie, Allergan (Tobira), Madrigal, Siemens, Foresite, Genentech, Axcella, Zydus, and Galectin. Dr. Chalasani receives research grant support from Intercept, Galectin Therapeutics, and Exact Sciences where his institution receives the funding. Mazen Noureddin has been on the advisory board or a speaker for Allergan, Gilead, Intercept, Pfizer, Novartis, Blade, EchoSens North America, OWL, Simply Speaking, Terns, Fractyl, Siemens, Roche Diagnostics, and Abbott; has received research support from Allergan, BMS, Gilead, Galmed, Galectin, Genfit, Conatus, Enanta, Novartis, Shire, and Zydus; is a minor shareholder or has stocks in Anaetos and Viking. Arun Sanyal is President of Sanyal Biotechnology and has stock options in Genfit, Akarna, Tiziana, Indalo, Durect, and Galmed. He has served as a consultant to Astra Zeneca, Nitto Denko, Enyo, Ardelyx, Conatus, Nimbus, Amarin, Salix, Tobira, Takeda, Jannsen, Gilead, Terns, Birdrock, Merck, Valeant, Boehringer-Ingelheim, Lilly, Hemoshear, Zafgen, Novartis, Novo Nordisk, Pfizer, Exhalenz, and Genfit. He has been an unpaid consultant to Intercept, Echosens, Immuron, Galectin, Fractyl, Syntlogic, Affimune, Chemomab, Zydus, Nordic Bioscience, Albireo, Prosciento, Surrozen, and Bristol-Myers Squibb. His institution has received grant support from Gilead, Salix, Tobira, Bristol-Myers, Shire, Intercept, Merck, Astra Zeneca, Malinckrodt, Cumberland, and Novartis. He receives royalties from Elsevier and UptoDate. Elmer Schabel, Lara Dimick-Santos, Stephanie O. Omokaro, Frank Anania, Veronica Miller and Katherine Barradas have nothing to disclose. Jean L. Chan was an employee of Conatus Pharmaceuticals during the preparation of this manuscript. Robert P. Myers is an employee of Gilead Sciences. The Liver Forum receives financial support from the following: Aligos Therapeutics, Allergan, AMRA, Arrowhead Pharmaceuticals, Blade Therapeutics, Bristol-Myers Squibb, Boehringer-Ingelheim, ChemomAb Ltd., Cirius Therapeutics Inc., Coherus BioSciences, Conatus Pharmaceuticals Inc., Covance Inc., CymaBay Therapeutics, EA Pharma Co., Ltd., Echosens, Eli Lilly, Enanta Pharmaceuticals, Inc., ENYO Pharma, E-SCOPICS, Ferring Pharmaceuticals, Galectin Therapeutics Inc., Genesis Imaging Services, GENFIT, Genkyotex, Gilead, Glympse Bio, GlaxoSmithKline, HepQuant, HighTide Therapeutics, HistoIndex Pte Ltd, Indalo Therapeutics, Intercept Pharmaceuticals, Inventiva Pharma, Madrigal Pharmaceuticals, Merck, Metacrine Inc., Mirum Pharmaceuticals, Morphic Therapeutic, NGM Biopharmaceuticals, Inc., Nitto BioPharma, Inc., Nordic Bioscience, NorthSea Therapeutics, Novartis, Novo Nordisk, Pfizer Inc., Pliant Therapeutics, ProSciento, Resoundant Inc., Robarts Clinical Trials, Sagimet Biosciences, Shire, Syneos Health, Takeda, TARGET PharmaSolutions, WuXiNextCODE, and Zafgen. The content of this paper represents the considerations and reflections of the authors, and does not necessarily represent the views of the US Food and Drug Administration, the U.S. Department of Health and Human Services, or the US government, Bundesinstitut fuer Arnzeimittel und Medizinprodukte, or the European Medicines Agency. Funding Information: Conflicts of interest The authors have made the following disclosures: Naga Chalasani has ongoing consulting activities (or had in preceding 12 months) with NuSirt, Abbvie, Allergan (Tobira), Madrigal, Siemens, Foresite, Genentech, Axcella, Zydus, and Galectin. Dr. Chalasani receives research grant support from Intercept , Galectin Therapeutics , and Exact Sciences where his institution receives the funding. Mazen Noureddin has been on the advisory board or a speaker for Allergan, Gilead, Intercept, Pfizer, Novartis, Blade, EchoSens North America, OWL, Simply Speaking, Terns, Fractyl, Siemens, Roche Diagnostics, and Abbott; has received research support from Allergan , BMS , Gilead , Galmed , Galectin , Genfit , Conatus , Enanta , Novartis , Shire , and Zydus ; is a minor shareholder or has stocks in Anaetos and Viking. Arun Sanyal is President of Sanyal Biotechnology and has stock options in Genfit, Akarna, Tiziana, Indalo, Durect, and Galmed. He has served as a consultant to Astra Zeneca, Nitto Denko, Enyo, Ardelyx, Conatus, Nimbus, Amarin, Salix, Tobira, Takeda, Jannsen, Gilead, Terns, Birdrock, Merck, Valeant, Boehringer-Ingelheim, Lilly, Hemoshear, Zafgen, Novartis, Novo Nordisk, Pfizer, Exhalenz, and Genfit. He has been an unpaid consultant to Intercept, Echosens, Immuron, Galectin, Fractyl, Syntlogic, Affimune, Chemomab, Zydus, Nordic Bioscience, Albireo, Prosciento, Surrozen, and Bristol-Myers Squibb. His institution has received grant support from Gilead, Salix , Tobira , Bristol-Myers , Shire, Intercept, Merck , Astra Zeneca , Malinckrodt , Cumberland , and Novartis. He receives royalties from Elsevier and UptoDate. Elmer Schabel, Lara Dimick-Santos, Stephanie O. Omokaro, Frank Anania, Veronica Miller and Katherine Barradas have nothing to disclose. Jean L. Chan was an employee of Conatus Pharmaceuticals during the preparation of this manuscript. Robert P. Myers is an employee of Gilead Sciences. The Liver Forum receives financial support from the following: Aligos Therapeutics, Allergan, AMRA, Arrowhead Pharmaceuticals, Blade Therapeutics, Bristol-Myers Squibb, Boehringer-Ingelheim, ChemomAb Ltd., Cirius Therapeutics Inc., Coherus BioSciences, Conatus Pharmaceuticals Inc., Covance Inc., CymaBay Therapeutics, EA Pharma Co., Ltd., Echosens, Eli Lilly, Enanta Pharmaceuticals, Inc., ENYO Pharma, E-SCOPICS, Ferring Pharmaceuticals, Galectin Therapeutics Inc., Genesis Imaging Services, GENFIT, Genkyotex, Gilead, Glympse Bio, GlaxoSmithKline, HepQuant, HighTide Therapeutics, HistoIndex Pte Ltd, Indalo Therapeutics, Intercept Pharmaceuticals, Inventiva Pharma, Madrigal Pharmaceuticals, Merck, Metacrine Inc., Mirum Pharmaceuticals, Morphic Therapeutic, NGM Biopharmaceuticals, Inc., Nitto BioPharma, Inc., Nordic Bioscience, NorthSea Therapeutics, Novartis, Novo Nordisk, Pfizer Inc., Pliant Therapeutics, ProSciento, Resoundant Inc., Robarts Clinical Trials, Sagimet Biosciences, Shire, Syneos Health, Takeda, TARGET PharmaSolutions, WuXiNextCODE, and Zafgen. The content of this paper represents the considerations and reflections of the authors, and does not necessarily represent the views of the US Food and Drug Administration, the U.S. Department of Health and Human Services, or the US government, Bundesinstitut fuer Arnzeimittel und Medizinprodukte, or the European Medicines Agency.
PY - 2020/8
Y1 - 2020/8
UR - http://www.scopus.com/inward/record.url?scp=85089549468&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85089549468&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2020.04.039
DO - 10.1053/j.gastro.2020.04.039
M3 - Editorial
C2 - 32353369
AN - SCOPUS:85089549468
SN - 0016-5085
VL - 159
SP - 422-427.e1
JO - Gastroenterology
JF - Gastroenterology
IS - 2
ER -