NASH_Tool_2

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PRIMARY CARE MASLD * Toolkit * Metabolic dysfunction-associated Steatotic Liver Disease (formally called NAFLD: Non-alcoholic Fatty Liver Disease) SCREENING PATHOPHYSIOLOGY and EPIDEMIOLOGY DIAGNOSIS PATIENT EDUCATION BIBLIOGRAPHY and GUIDELINES MANAGEMENT

Screening Who’s at greatest risk and would benefit most from screening? • Patients who are overweight (85-94th percentile for pediatrics; BMI 25*-29.9kg/m²) or have obesity (≥ 95th percentile for pediatrics; BMI ≥ 30kg/m²). • Patients with Type 2 diabetes or prediabetes (fasting glucose ≥ 100mg/dL, A1C ≥ 5.7, or 2-h OGTT ≥140 mg/dL). • Patients with one or more features of metabolic dysregulation: ◦ Central adiposity (weight circumference > 94 cm in males, 80 cm in females, or 95th percentile for pediatric patients). ◦ Insulin resistance (polycystic ovary syndrome, acanthosis nigricans). ◦ Obstructive sleep apnea. ◦ Triglycerides > 150 mg/dL in those 10 years or older (≥ 100mg/dL in people under 10 years). ◦ HDL-C < 50 mg/dL (men) or < 40mg/dL (women and pediatrics). ◦ Blood pressure ≥ 130/85 mm Hg (or ≥ 95th percentile for pediatric patients). • Patients with a family history of MASLD. When and how often should I screen? • Start at ages 9-11 for pediatric patients. • Screen every two to three years thereafter (more often if more risk factors develop). How should I screen? • For pediatrics, screen with ALT (considered a positive screen if 22 U/L for girls and 26 U/L for boys). • For adults, ALT and Fibrosis-4 (FIB- 4) score or nonalcoholic fatty liver disease score (NFS)^. What do I do with a positive screen? • MASLD is a diagnosis of exclusion, so rule out other causes of elevated ALT/AST with history, physical exam and appropriate laboratory tests. See the diagnostic tools page. • Determine risk of advanced fibrosis. *23kg/m² for those with Asian genetic heritage, ^ requires ALT,AST, and platelets level to be drawn first. NFS requires addition of albumin. Abbreviations: A1C, glycosylated hemoglobin A1C; ALT, alanine aminotransferase, BMI, body mass index; FIB-4HDL-C, high-density lipoprotein-cholesterol; OGTT, oral glucose tolerance test; Kanwal et al., 2021, Rinella, Lazarus, et all., 2023, Rinella, Neuschwander-Tetri, et al., 2023, Vos et al., 2017

Pathophysiology, epidemiology and nomenclature • MASLD affects 25% of adults in the United States, and more than 25% of those with MASLD have the more severe form — metabolic dysfunction-associated steatohepatitis (MASH). (Figure 1) • MASLD was formerly known by terms such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic fatty liver (NAFL) and non- alcoholic steatohepatitis (NASH). In 2023, international experts reached a consensus to rename the condition to reduce the stigma associated with old nomenclature and better capture the pathophysiology of the problem (Rinella et al., 2023). MASLD is now considered a type of steatotic liver disease (SLD). (Figure 2) • It can be hard to predict who will go on to develop MASH (the more severe form). Genetics influences much of this and is an area of ongoing research. • MASLD and MASH are increasing in prevalence and are expected to become leading reasons for liver transplantation in the near future. • Patients with MASLD have an increased risk of liver-related mortality and morbidity, but it is actually cardiovascular disease (CVD) that is the leading cause of mortality for patients with MASLD. • Patients with Asian or Hispanic genetic heritage may develop MASLD at a leaner body mass than other patients. • It is possible to have SLD from both metablic dysfunction and excess alcohol use. In the presence of both, the term MetALD is used. (Figure 2) Calzadilla Bertot, L., & Adams, 2016, Cholenkeril & Ahmed, 2016; Dielhl & Day, 2017, Rinella, Lazarus, et all., 2023, Rinella, Neuschwander-Tetri, et al., 2023 Figure 1. Pathophysiologic progression of SLD. First, steatosis develops. Over time and with the influence of genetics and multiple other factors, inflammation can develop, however, in some patients, inflammation never develops and these patients never progress into the severe forms of SLD. When inflammation is present, the term steatohepatitis is used. Eventually, steatohepatitis can cause fibrosis, which can progress to advanced stages and eventually cirrhosis. The progression to advanced fibrosis can occur as quickly as six years in some patients but usually happens over 10-15 years. With MASLD, the focus is to differentiate patients with early versus advanced fibrosis, since patients with advanced fibrosis are best managed by hepatology and gastroenterology. The challenge is that MASLD is often a silent disease with few signs or symptoms, requiring an astute clinician! Figure 2. SLD is used to refer to liver damage from a variety of etiologies, including MASLD, alcohol overuse (ALD), both metabolic dysfunction and alcohol overuse (MetALD) or other causes, such as autoimmune conditions or medication side effects (drug-induced liver injury [DILI]) (Rinella et al., 2023).

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DiagnosTIC TOOLS • SLD is often silent and, without high suspicion, may only be identified incidentally from ALT/AST elevations or steatosis on liver ultrasound. • MASLD should be a diagnosis of exclusion. Rule out other etiologies, such as alcohol, autoimmune conditions and infectious hepatitis, with history, physical and laboratory testing. • Normal ALT/AST is not sensitive enough to exclude the possibility of MASLD, so patients could still have MASLD despite normal AST/ALT. In adults, if suspicion for MASLD is high enough, continue to screen for advanced fibrosis with FIB-4 or NFS, even if AST/ALT levels are normal. • A liver biopsy was traditionally the only way to differentiate between mild and advanced fibrosis. However, a biopsy is costly, has risks and requires expert training. So, easier, more accessible and safer approaches like the NFS, FIB-4 and LSM have been developed. • The NFS and FIB-4 are only validated for adult use and should not be used in patients under age 18. They are most accurate in people older than age 35. Cusi et al., 2022, Kanwal et al., 2021, Rinella, Neuschwander-Tetri, et al., 2023, Vos et al., 2017 DiagnosTIC TIPS The Audit-C is a tool used to screen for excessive use of alcohol, and it can help determine if alcohol could be contributing to liver dysfunction. The FIB-4 Score is one of two non- invasive options that can be used to screen and diagnose advanced fibrosis in patients with suspected MASLD. The NAFLD Fibrosis Score (NFS) is one of two non-invasive options that can be used to screen and diagnose advanced fibrosis in patients with suspected MASLD. All patients being evaluated for MASLD should have hepatitis C ruled out before a diagnosis of MASLD is made. Also, consider hepatitis B screening if at risk. Liver stiffness measurement (LSM) is measured through vibration-controlled transient elastography (VCTE). Figure 1. MASLD identification algorithm AUDIT-C FIB-4 NFS HEPATITIS C SCREEN LSM/VCTE

Patient Education The Harvard Healthy Eating Plate is recommended by MASLD experts for nutrition counseling. The Mediterranean diet is recommended by MASLD experts for nutrition counseling and weight loss. Avoiding excess sugar in the diet, including sugar-sweetened beverages, is important. Sugar Stacks is a website to help illustrate how much sugar is in food and drinks. Exercise recommendations for patients with MASLD are the same as those for cardiovascular health. This resource from the American Heart Association helps patients understand target heart rate and exercising for health. Patients should be encouraged to exercise at least 150 minutes per week. Healthy Eating Plate Mediterranean Diet Sugar Stacks Targeting Heart Rate This is a good video to show your patients and educate them about MASLD. This patient education handout has good pictures to use when teaching patients about MASLD. This patient education resource reviews safe alcohol consumption guidelines. Download this brief one-pager, which can be used to help you educate patients. Fighting Fatty Livers Patient Handbook What Is a Standard Drink Patient One-pager

Management Management of MASLD in primary care also heavily focuses on encouraging healthy nutrition, exercise and weight loss. Motivational interviewing skills are helpful when motivating patients to adopt these lifestyle practices! Click above for some resources on how to use motivational interviewing! The link above will take you to guidelines for the management of obesity. Even 5-10 % weight loss can improve fibrosis severity or minimize chances of progression. Motivational Interviewing Resources Obesity Management Guidelines • Management of MASLD in primary care focuses on maximizing treatment of metabolic dysfunction through controlling diabetes, dyslipidemia and hypertension with both pharmacotherapy and nonpharmacotherapy strategies, as recommended by guidelines. • In patients with diabetes, GLP-1RAs and pioglitazone are recommended for prioritized consideration as part of the treatment plan, since these medications have been shown to benefit patients with MASLD. • Patients should also be counseled to refrain from using alcohol since alcohol use can accelerate fibrosis progression. • Several novel pharmacotherapies are in Stage 2-3 trials, so be sure to stay tuned for updates in the near future! • When MASLD occurs in a patient who also has excess alcohol use, the condition is diagnosed as MetALD and the management plan includes both management of excess alcohol use and metabolic dysfunction. WHEN TO REFER TO HEPATOLOGY OR GASTROENTEROLOGY • LSM is unavailable in your area and recommended based on FIB-4 or NFS. • High risk score on FIB-4, NFS or LSM. • Evidence of cirrhosis — may be identified for the first time by imaging or during evaluation for a new GI bleed. Note: Decompensated cirrhosis occurs when ascites, hepatic encephalopathy or esophageal varices are present. Compensated cirrhosis can often be “silent.” Rinella, Neuschwander-Tetri, et al., 2023, Vos et al., 2017, Yee et al., 2017

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Bibliography • Agency for Healthcare Research and Quality. (2020). Screening and Treating Non-Alcoholic Fatty Liver Disease. https://effectivehealthcare.ahrq.gov/system/files/docs/na_liver_disease_topic_brief_topic_brief.pdf • Calzadilla Bertot, L., & Adams, L. (2016). The Natural Course of Non-Alcoholic Fatty Liver Disease. International Journal of Molecular Sciences, 17(5), 774. https://doi.org/10.3390/ijms17050774 • Cholankeril, G., & Ahmed, A. (2018). Alcoholic Liver Disease Replaces Hepatitis C Virus Infection as the Leading Indication for Liver Transplantation in the United States. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association, 16(8), 1356–1358. https://doi.org/10.1016/j.cgh.2017.11.045 • Cusi, K., Isaacs, S., Barb, D., Basu, R., Caprio, S., Garvey, W. T., Kashyap, S., Mechanick, J. I., Mouzaki, M., Nadolsky, K., Rinella, M. E., Vos, M. B., & Younossi, Z. (2022). American Association of Clinical Endocrinology Clinical Practice Guideline for the Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Primary Care and Endocrinology Clinical Settings: Co-Sponsored by the American Association for the Study of Liver Diseases (AASLD). Endocrine Practice: Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, 28(5), 528–562. https://doi.org/10.1016/j.eprac.2022.03.010 • Diehl, A. M., & Day, C. (2017). Cause, Pathogenesis, and Treatment of Nonalcoholic Steatohepatitis. New England Journal of Medicine, 377(21), 2063–2072. https://doi.org/10.1056/NEJMra1503519 • Kanwal, F., Shubrook, J. H., Adams, L. A., Pfotenhauer, K., Wai-Sun Wong, V., Wright, E., Abdelmalek, M. F., Harrison, S. A., Loomba, R., Mantzoros, C. S., Bugianesi, E., Eckel, R. H., Kaplan, L. M., El-Serag, H. B., & Cusi, K. (2021). Clinical Care Pathway for the Risk Stratification and Management of Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology, 161(5), 1657–1669. https://doi.org/10.1053/j.gastro.2021.07.049 • National Institute on Alcohol Abuse and Alcoholism (NIH). (n.d.). What Is A Standard Drink? https://www.niaaa.nih.gov/alcohols-effects-health/overview-alcohol-consumption/what-standard-drink • Rinella, M. E., Lazarus, J. V., Ratziu, V., Francque, S. M., Sanyal, A. J., Kanwal, F., Romero, D., Abdelmalek, M. F., Anstee, Q. M., Arab, J. P., Arrese, M., Bataller, R., Beuers, U., Boursier, J., Bugianesi, E., Byrne, C., Castro Narro, G. E., Chowdhury, A., Cortez-Pinto, H., … on behalf of the NAFLD Nomenclature consensus group. (2023). A multi-society Delphi consensus statement on new fatty liver disease nomenclature. Hepatology, Publish Ahead of Print. https://doi.org/10.1097/HEP.0000000000000520 • Rinella, M. E., Neuschwander-Tetri, B. A., Siddiqui, M. S., Abdelmalek, M. F., Caldwell, S., Barb, D., Kleiner, D. E., & Loomba, R. (2023). AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology, 77(5), 1797–1835. https://doi.org/10.1097/HEP.0000000000000323 • Vos, M. B., Abrams, S. H., Barlow, S. E., Caprio, S., Daniels, S. R., Kohli, R., Mouzaki, M., Sathya, P., Schwimmer, J. B., Sundaram, S. S., & Xanthakos, S. A. (2017). NASPGHAN Clinical Practice Guideline for the Diagnosis and Treatment of Nonalcoholic Fatty Liver Disease in Children: Recommendations from the Expert Committee on NAFLD (ECON) and the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Journal of Pediatric Gastroenterology & Nutrition, 64(2), 319–334. https://doi.org/10.1097/MPG.0000000000001482 • Yee, H. F. (2017). The Role of Pioglitazone in the Management of Nonalcoholic Steatohepatitis: Are We There Yet? JAMA Internal Medicine, 177(5), 640. https://doi.org/10.1001/jamainternmed.2016.9669 GUIDELINES American College of Gastroenterology: Evaluation of Elevated Liver Chemistries North American Society of Pediatric Gastroenterology, Hepatology and Nutrition MASLD Guidelines American Association for the Study of Liver Disease MASLD Guidelines Supported by independent medical educational grants from Madrigal Pharmaceuticals & Novo Nordisk Inc.

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