Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations From the Multi-stakeholder Liver Forum

Liver Forum NASH Cirrhosis Working Group

doi:10.1053/j.gastro.2020.04.039

Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations From the Multi-stakeholder Liver Forum

Liver Forum NASH Cirrhosis Working Group

Research output: Contribution to journal › Editorial › peer-review

Original language	English (US)
Pages (from-to)	422-427.e1
Journal	Gastroenterology
Volume	159
Issue number	2
DOIs	https://doi.org/10.1053/j.gastro.2020.04.039
State	Published - Aug 2020

ASJC Scopus subject areas

Hepatology
Gastroenterology

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10.1053/j.gastro.2020.04.039

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@article{9ce3847da3fe46d2bcff918562db6ae2,

title = "Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations From the Multi-stakeholder Liver Forum",

author = "{Liver Forum NASH Cirrhosis Working Group} and Mazen Noureddin and Chan, {Jean L.} and Katherine Barradas and Lara Dimick-Santos and Elmer Schabel and Omokaro, {Stephanie O.} and Anania, {Frank A.} and Myers, {Robert P.} and Veronica Miller and Sanyal, {Arun J.} and Naga Chalasani and Jasmohan Bajaj and Annalisa Berzigotti and Pascal Birman and Jaime Bosch and Ashley Brower and Dania Calboli and William Charlton and Klara Dickinson and Claudia Filozof and Forsgren, {Mikael F.} and Michael Fuchs and Guadalupe Garcia-Tsao and Juan Gonzalez-Abraldes and Gruss, {Hans Juergen} and Morten Hansen and Suneil Hosman and Joanne Imperial and David Jones and Gadi Lalazar and Leinhard, {Olof Dahlqvist} and Erica Lyons and Brian McColgan and Ruby Mehta and Peter Mesenbrink and Rob Myers and Veronica Pei and Vlad Ratziu and Arie Regev and Robert Riccio and Arun Sanyal and Suna Seo and Alastair Smith and Peter Szitanyi and Peter Traber",

note = "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. ",

year = "2020",

month = aug,

doi = "10.1053/j.gastro.2020.04.039",

language = "English (US)",

volume = "159",

pages = "422--427.e1",

journal = "Gastroenterology",

issn = "0016-5085",

publisher = "W.B. Saunders Ltd",

number = "2",

}

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 -

Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations From the Multi-stakeholder Liver Forum

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