Gastroenterology

Gastroenterology

Volume 161, Issue 5, November 2021, Pages 1657-1669
Gastroenterology

AGA Section
Clinical Care Pathway for the Risk Stratification and Management of Patients With Nonalcoholic Fatty Liver Disease

https://doi.org/10.1053/j.gastro.2021.07.049Get rights and content

Find AGA's NASH Clinical Care Pathway App for iOS and Android mobile devices at nash.gastro.org. Scan this QR code to be taken directly to the website.Nonalcoholic fatty liver disease (NAFLD) is becoming increasingly common, currently affecting approximately 37% of US adults. NAFLD is most often managed in primary care or endocrine clinics, where clinicians must determine which patients might benefit from secondary care to address hepatic manifestations, comorbid metabolic traits, and cardiovascular risks of the disease. Because NAFLD is largely asymptomatic, and because optimal timing of treatment depends on accurate staging of fibrosis risk, screening at the primary care level is critical, together with consistent, timely, evidence-based, widely accessible, and testable management processes. To achieve these goals, the American Gastroenterological Association assembled a multidisciplinary panel of experts to develop a Clinical Care Pathway providing explicit guidance on the screening, diagnosis, and treatment of NAFLD. This article describes the NAFLD Clinical Care Pathway they developed and provides a rationale supporting proposed steps to assist clinicians in diagnosing and managing NAFLD with clinically significant fibrosis (stage F2–F4) based on the best available evidence. This Pathway is intended to be applicable in any setting where care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.

Keywords

Nonalcoholic Fatty Liver Disease
NAFLD
Nonalcoholic Steatohepatitis
NASH
Liver Disease
Clinical Care Pathway

Abbreviations used in this paper

CI
confidence interval
FIB-4
Fibrosis-4
GLP-1RA
glucagon-like peptide 1 receptor agonist
HCC
hepatocellular cancer
LSM
liver stiffness measurement
MRE
magnetic resonance elastography
NAFLD
nonalcoholic fatty liver disease
NASH
nonalcoholic steatohepatitis
NIT
novel imaging technique
RCT
randomized controlled trial
SGLT2
sodium-glucose co-transporter-2
T2D
type 2 diabetes
VCTE
vibration controlled transient elastography

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Conflicts of interest These authors disclose the following: Jay H. Shubrook has served as an advisor to Sanofi, Eli Lilly, Novo Nordisk, Bayer, and MannKind. Leon A. Adams has served on advisory boards for Novartis, Pfizer, and Metavention and holds patents for Hepascore. Vincent Wai-Sun Wong served as a consultant or advisory board member for 3V-BIO, AbbVie, Allergan, Boehringer Ingelheim, Center for Outcomes Research in Liver Diseases, Echosens, Gilead Sciences, Hanmi Pharmaceutical, Intercept, Inventiva, Merck, Novartis, Novo Nordisk, Perspectum Diagnostics, Pfizer, ProSciento, Sagimet Biosciences, TARGET PharmaSolutions, and Terns; and a speaker for Abbott, AbbVie, Bristol-Myers Squibb, Echosens, and Gilead Sciences. He has received a grant from Gilead Sciences for fatty liver research, and is a co-founder of Illuminatio Medical Technology Limited. Manal F. Abdelmalek has received research funding (paid to her institution) from Genfit, Gilead, Galmed, Galactin, BMS, NGM Bio, Intercept, Allergan, Novo-Nordisk, Novartis, Celgene, Genentech, Hanmi, Boeringher-Ingelheim, Madrigal, Viking, Progenity, TARGET NASH, Enyo, Enanta, Inventiva, Poxel, and Durect. She has served as a consultant or advisory board member to BMS, NGM, Intercept, Madrigal, Hanmi, SonicIncytes, Inventiva, Merck, 89Bio, and NovoNordisk. Elisabetta Bugianesi has served as a consultant to Gilead, BMS, Boehringer, Intercept, and Innova. Robert H. Eckel has served on advisory boards for Novo Nordisk, Provention Bio, Kaleido, and KOWA, and a scientific advisory committee for PROMINENT (CVOT). He has received research funding from Gilead (2014-2015), Merck (2016-2018), and Wako (2014-2017). Christos S. Mantzoros reports grants, personal fees, and other from AltrixBio, Coherus Biosciences, and Novo Nordisk, personal fees and nonfinancial support from Ansh, Aegerion, California Walnut Commission, and personal fees from Lumos, GENFIT, Intercept, Regeneron, CardioMetabolic Health Conference, The Metabolic Institute of America and Amgen. Kenneth Cusi has received research support for the University of Florida as principal investigator from Cirius, Echosens, Inventiva, Novo Nordisk, Poxel, and Zydus and is a consultant for Allergan, Arrowhead, Astra-Zeneca, Axcella, BMS, Boehringer Ingelheim, Coherus, Eli Lilly, Fractyl, Hanmi, Genentech, Gilead, HighTide, Inventiva, Intercept, Ionis, Janssen, Pfizer, Poxel, Prosciento, Madrigal, and Novo Nordisk. Rohit Loomba serves as a consultant for Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Bristol-Myer Squibb, CohBar, Eli Lilly, Galmed, Gilead, Glympse bio, Hightide, Inipharm, Intercept, Inventiva, Ionis, Janssen Inc, Madrigal, Metacrine, Inc, NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89 bio, and Viking Therapeutics. In addition, his institution has received grant support from Allergan, Astrazeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galectin Therapeutics, Galmed Pharmaceuticals, Genfit, Gilead, Intercept, Inventiva, Janssen, Madrigal Pharmaceuticals, Merck, NGM Biopharmaceuticals, Pfizer, and Sonic Incytes. He is also co-founder of Liponexus, Inc. Stephen A. Harrison serves as a consultant for Akero, Alentis, Altimmune, Arrowhead, Axcella, Canfite, Cirius, CiVi Bopharma, Echosens, Fibronostics, Forest Labs, Galectin, Genfit, Gilead, Hepion, Hightide, HistoIndex, Intercept, Inipharm, Madrigal, Medpace, Metacrine, NGM Bio, Northsea, Novartis, Novo Nordisk, Path AI, Poxel, Liminal, Sagimet, Terns, Viking and 89Bio. The remaining authors disclose no conflicts.

Funding This article is based on work sponsored by the American Gastroenterological Association, with the financial support of independent medical education grants from Intercept Pharmaceuticals, Inc, Pfizer Inc, Allergan, and GENFIT, and the support of the following collaborating medical associations: American Association of Clinical Endocrinologists, American Academy of Family Physicians, American Association for the Study of Liver Diseases, American College of Osteopathic Family Physicians, American Diabetes Association, the Endocrine Society, and The Obesity Society. Dr Kanwal is an investigator at the Veterans Administration Center for Innovations in Quality, Effectiveness and Safety (CIN 13-413), Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas and is supported in part by the National Cancer Institute (NCI U01 CA230997) and Cancer Prevention and Research Institute of Texas grant (RP150587). Dr Abdelmalek is supported in part by the National Institute of Health Nonalcoholic Steatohepatitis Clinical Research Network (DK061713-19). Dr Loomba receives funding support from National Institute of Environmental Health Science (5P42ES010337), National Center for Advancing Translational Sciences (5UL1TR001442), Department of Defense Peer Reviewed Cancer Research Program (W81XWH-18-2-0026), National Institute of Diabetes and Digestive and Kidney Diseases (U01DK061734, R01DK106419, R01DK121378, R01DK124318, P30DK120515), National Heart, Lung, and Blood Institute (P01HL147835), and National Institute on Alcohol Abuse and Alcoholism (U01AA029019).

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