The study highlights critical need to take urgent actions for proactive and routine screening of NAFLD/NASH among at-risk asymptomatic adults in the United States

November 30, 2021; Boise, IDAHO — The Fatty Liver Foundation (FLF) today announced data from its SUNN-1 study published in PLOS ONE, a peer-reviewed, open access scientific journal, evaluating risk factors for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) based on vibration controlled transient elastography (VCTE) and controlled attenuation parameter (CAP) among a self-selecting group of undiagnosed and asymptomatic individuals in real-life, community-based settings. 

NAFLD is a growing cause of chronic liver disease worldwide. It is characterized by steatosis or infiltration of liver cells with fat, liver inflammation, hepatocellular or liver cells injury, and progressive fibrosis. NASH, an advanced form of NAFLD, is clinically significant and can lead to progressive liver fibrosis, cirrhosis, and eventually advanced liver disease, liver cancer, and death. 

NAFLD has become the most common form of chronic liver disease in the United States and places a heavy burden on individuals, families, and healthcare resources and utilization. The number of NAFLD cases among the adult population (aged ≥ 15 years) in the United States is anticipated to increase exponentially due to the growing epidemic of obesity and diabetes. By 2030, the overall prevalence of NAFLD is projected at 33.5% with NASH increasing to 27%.[1] Despite recent scientific and medical advances, there are currently no effective treatments for NAFLD. Currently, the only proven effective therapy for NAFLD/NASH is sustained weight loss achieved through diet and exercise or bariatric surgery. 

The level of screening for NAFLD among at-risk and asymptomatic populations remains woefully inadequate especially in primary care and community-based settings. Majority of patients with cirrhosis due to NASH are diagnosed incidentally or have never had prior evaluation or diagnosis. Currently, the American Association for the Study Liver Diseases (AASLD) does not recommend routine screening of NAFLD among at-risk, asymptomatic populations. 

This study sponsored by FLF sought to determine whether a self-selecting group of asymptomatic individuals would have scores based on VCTE and CAP correlated with risk factors to suggest that routine screening for at-risk individuals should be recommended. 

The study recruited 1,070 self-selected participants in South Houston and Galveston County, Texas at various community-based settings, including health fairs, the Mexican Consulate General in Houston, Federally Qualified Health Centers (FQHCs), the Galveston County Health Department, and workplace wellness initiatives through the Domestic Workers Association and local small businesses. A pre-screening survey was used to collect demographic and health history information, such as metabolic and other health conditions, diet and exercise habits, alcohol intake, and presence of other liver diseases. Community-based screening for NAFLD/NASH was performed using FibroScan®, a portable non-invasive imaging device that measures fat content or steatosis and liver stiffness or fibrosis. Participants were categorized into four groups based on fibrosis and steatosis findings: no fat and no stiffness, no fat with stiffness, fat without stiffness, and fat with stiffness. Each participant was provided with a copy of her or his FibroScan® results that could be used for future healthcare decisions. In addition, each participant was provided with a packet of information about NAFLD/NASH, all current treatment options, a status report on treatments being studied in FDA-approved clinical trials, and contact information for additional resources. Those with elevated FibroScan® scores were strongly advised to seek follow-up care with their primary care provider or a liver specialist. 

Results of 940 individuals were analyzed. The median age was 48 and women accounted for 67% of the population. The majority of participants were overweight or obese, and the most commonly reported comorbidities were diabetes (26%), high blood pressure (28%), and high cholesterol (28%). 

The majority of the study population, 57%, had fibrosis and steatosis scores that indicated liver fat without stiffness. 24% indicated no fat and no stiffness, 16% indicated fat with stiffness, and 2% indicated no fat with stiffness. 

Among the study population with a proxy NAFLD diagnosis, defined by the study as CAP score of S3, 67% were clinically obese (BMI≥30), 38% were diabetic, 34% had hypertension, 33% had high cholesterol, and 16% had high triglyceride levels. Among the study population with a proxy NASH diagnosis, defined by the study as a TE score of F3 or F4, 90% were clinically obese, 45% had hypertension, 6% had a history of stroke, and 35% had a history of arthritis. 

“Based on these findings, this study sponsored by FLF establishes the substantial burden of NAFLD/NASH using VCTE in real-life, community-based settings and underscores the urgent and critical need for public health measures to more proactively screen and detect NAFLD/NASH among at-risk and asymptomatic populations,” said Wayne Eskridge, CEO and Co-Founder of FLF and the study’s co-primary investigator. 

“Most patients with NASH have no symptoms and when first diagnosed may have already developed advanced disease,” said Dr. John M. Vierling, Professor of Medicine and Surgery, Chief of Hepatology at Baylor College of Medicine, Director of Advanced Liver Therapies Program, and the study’s co-primary investigator. “This is why these findings from this FLF-sponsored screening study are so important and that urgent actions to address the unmet needs for awareness of NAFLD are crucial for at-risk individuals to take personal action to seek a diagnosis.”

“Community-based screening efforts create an opportunity for at-risk and undiagnosed individuals to become informed about their disease status and can spark a teachable moment to encourage care seeking behavior from providers who would be otherwise unlikely to recommend screening, diagnosis, and downstream disease management,” said Dr. Neeraj Mistry, Chief Medical Officer of FLF. 

Reference

[1] Estes C, Razavi H, Loomba R, Younossi Z, and Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology 2018; 67(1):123-133. 

About the Fatty Liver Foundation

The Fatty Liver Foundation is a non-profit patient organization dedicated to improving the identification, diagnosis, treatment and support of people living with fatty liver, NAFLD or NASH through awareness, screening, education, and patient outreach. FLF’s goal is to improve the lives of both asymptomatic and diagnosed patients by raising awareness, advancing wellness screening, educating patients, and championing the development of responsive support systems for individuals of the growing epidemic of fatty liver disease. Connect with us on www.fattyliverfoundation.org, Facebook (Fatty Liver Foundation JUST LIVER NEWS), Twitter (@LiverSaver), and YouTube (Fatty Liver Foundation).

Media Contact

Fatty Liver Foundation

Henry E. Chang | Mobile +1 917 400 8900 | [email protected]

In your coverage, please use this URL to provide access to the freely available paper in PLOS ONE entitled “Screening for undiagnosed non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH): a population-based risk factor assessment using vibration controlled transient elastography (VCTE): https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0260320 

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