The NAFLD Screening Fund is a collaborative effort led by FLF. Our partners and supporters will continue to grow as the Fund expands.

Our partners, those who support the Fund, are:

Ms. Athena Pei Tung

Our supporters, those who have expressed interest in becoming a partner of the Fund, are:

WHAT'S THE PROBLEM?

100 million people have NAFLD and don't know it

20 million people have NASH and don't know it

5 million people have cirrhosis and don't know it

• A tsunami of disease is building in society and being exacerbated by the current COVID-19 pandemic
• Most people have no knowledge of NASH and doctors rarely warn patients of risk or attempt diagnosis absent symptoms
• There are no treatments and not enough patients to fill clinical trials necessary for approval

THE SOLUTION

Mobilize a public-private partnership

• Supporting broad outreach through patient advocates
• Mobilizing local community peer-to-peer groups
• Increasing uptake of preventive screening practices

THE PAYOFF 

Healthier, smarter patients, better care, reduced cost, improved participant pool

• Saving lives through continued education & monitoring
• Encouraging participation via robust clinical trial support
• Improving collaboration instead of stifling competition

With recent advancements in the diagnostics and potential treatments for NAFLD, screening and testing are now the critical nexus between identification of disease and effective intervention. To meet this need, the NAFLD Screening Fund’s primary objective is to scale-up evidence-based screening and testing for NAFLD. Funded activities would boost the screening practices needed to identify asymptomatic disease and staging of NAFLD/NASH patients.

The expansion of screening and staging of fatty liver disease is a model of community outreach that has been proven by FLF in medical and non-medical settings. The Fund’s impact will be expanded education and awareness of NAFLD, achieved through screening, which has been shown to empower individuals’ ownership and participation in their health and healthcare. Through multiple site collaborations, new screening technologies, improved data management systems, and more trained personnel, the Fund will be leveraged to rapidly scale up community screening efforts. The NAFLD Screening fund will be the catalyst for greater patient engagement in research and development, including treatment preparedness as new therapies become available. It is a mechanism through which many streams of financial support, both public and private, can be coordinated and focused on this rapidly growing health threat.

Thank you for your interest in the NAFLD Screening Fund!

We are looking for both partners and supporters for the Fund. If you would like to learn more about what being a partner or supporter entails or have any other questions, please email us at [email protected]. We are happy to communicate over email or to set up a time to connect over Zoom. Please let us know your preference and we will get back to you as soon as possible. 

Fatty Liver Foundation Launches a Public-Private Partnership to Combat the Silent Epidemic of Nonalcoholic Fatty Liver Disease (N)

Liver disease is an ignored epidemic. FLF intends to change the paradigm with the NAFLD Screening Fund.

 Building on the experience of FLF, the leading patient advocacy organization, the NAFLD Screening Fund aims to identify and support at-risk populations to combat the rising incidence and mortality of NAFLD in the United States.

The Fatty Liver Foundation (FLF) is launching the NAFLD Screening Fund, a new five-year, multi-stakeholder, public-private partnership aimed at accelerating progress in the detection, diagnosis, staging, care, and research of non-alcoholic fatty liver disease (NAFLD) among at-risk and asymptomatic populations in the United States, where there is a significant unmet need.

Despite advances in research, diagnosis, and care, NAFLD places a heavy burden on individuals, families, and health care systems. Before COVID-19, it was estimated that more than 100 million Americans had NAFLD or its more advanced and aggressive form, non-alcoholic steatohepatitis (NASH), and most were unaware of it. Since the onset of COVID-19, the average American has gained 29 pounds, contributing to the growing burden of noncommunicable lifestyle diseases such as obesity and diabetes, and greatly increasing the at-risk population who remain undiagnosed for NAFLD. The societal tragedy is that if diagnosed and addressed early enough, NAFLD can be reversed.

The level of screening for NAFLD among high-risk and asymptomatic populations remains woefully inadequate in medical and community-based settings and this lack of services has only been exacerbated by COVID-19. People with NAFLD and metabolic syndrome are four times more likely to develop severe manifestations of COVID-19 than those without NAFLD, regardless of the presence of diabetes. With COVID-19 disproportionately impacting people at-risk for and living with NAFLD by threatening their timely diagnosis and care, and increasing their risk of severe disease, it is more urgent than ever to address these health disparities. Though these same issues exist nationwide, they are particularly acute in under served and non-white communities.

“Our commitment to re-imagining NAFLD screening goes beyond FLF’s SUNN-1 (Screening for Undiagnosed NAFLD and NASH) study, to helping close the gaps in prevention and linkage to care and/or clinical trials for at-risk, asymptomatic populations through innovative screening models in underserved communities,” said Wayne Eskridge, CEO and Co-Founder of FLF. “We must work with other organizations and stakeholders in order to successfully raise awareness, address health disparities, and increase access to screening. We are at a tipping point where we can help catalyze and change the course of NAFLD diagnosis and care for all Americans.”

“The number of NAFLD cases is rising rapidly among the U.S. adult population (aged ≥15 years), and prior to COVID-19 was projected to reach 33.5% in 2030. We don’t yet know how extensive the long-term damage of the pandemic will be for chronic disease patients, but we can expect that it will likely catalyze more serious problems. Unfortunately, we are already making most diagnoses late in the course of disease, leading to potentially serious complications and outcomes,” says Neeraj Mistry, MD, MPH, Chief Medical Officer of FLF. “The NAFLD Screening Fund is part of FLF’s broader commitment to mobilize new resources and strengthen the capacity of key NAFLD stakeholders to reverse these trends. This new initiative not only promises to prevent thousands of premature deaths, but also to contribute to greater equity in NAFLD care and research.”

FLF’s NAFLD Screening Fund is a public-private partnership to mobilize leading organizations from the private sector, philanthropic foundations, public health agencies, and non-profit organizations. The Fund is supported by leading companies and individuals from the private and philanthropic sectors including Applied Clinical Education, CME Zone, Gastroenterology & Endoscopy News, Madrigal Pharmaceuticals, Inc., McMahon Group, and Terns Pharmaceuticals, Inc., and Ms. Athena Pei Tung.

The NAFLD Screening Fund aims to achieve the following outcomes by 2026:

1. Fund community-based screening projects for NAFLD/NASH in undiagnosed, asymptomatic at-risk populations.
2. Drive awareness of NAFLD and the importance of early detection.
3. Foster education about healthy lifestyles.
4. Support NAFLD and NASH patients with linkage to care and clinical trial enrollment education.
5. Strengthen networks and collaborations for NAFLD/NASH screening at local, regional, and national levels.
6. Unite the voice of the NAFLD/NASH community, including patient organizations and groups, to advocate for more effective NAFLD/NASH screening, staging and care.
7. Provide data to guide research and regulatory decision making where patient interests are impacted.

“Key to reversing the rise in NAFLD cases and mortality rates is our ability to work together to leverage and expand the will and resources that currently exist, supporting the creation of a common agenda to maximize impact through collective action,” says Henry E. Chang, Executive Director of FLF. “In practical terms, with the necessary funding and expertise, the NAFLD Screening Fund has the potential to support 50,000 NAFLD patients, fund various scalable and sustainable NAFLD screenings and linkage to care projects that are designed to address health disparities among at-risk and under served populations, and help accelerate the development of drug regimens for the treatment of NAFLD and NASH.”

Learn how you can help support the NAFLD Screening Fund and address this significant unmet need by signing up here.

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). 

About the NAFLD Screening Fund

With recent advancements in the diagnostics and potential treatments for NAFLD, screening and testing are now the critical nexus between identification of disease and effective intervention. To meet this need, the NAFLD Screening Fund’s primary objective is to scale-up evidence-based screening and testing for NAFLD. Funded activities will boost the screening practices needed to identify asymptomatic disease and staging of NAFLD/NASH patients.

The expansion of screening and staging of fatty liver disease is a model of community outreach that has been proven by FLF in medical and non-medical settings. The Fund’s impact will be expanded education and awareness of NAFLD, achieved through screening, which has been shown to empower individuals’ ownership and participation in their health and healthcare. Through multiple site collaborations, new screening technologies,  improved data management systems, and more trained personnel, the Fund  will be leveraged to rapidly scale up community screening efforts. The NAFLD Screening Fund will be the catalyst for greater patient engagement in research and development, including treatment preparedness as new therapies become available. It is a mechanism through which many streams of financial support, both public and private, can be coordinated and focused on this rapidly growing health threat.

FACT SHEET

Many patients in our forums report experiencing right upper quadrant (RUQ) pain. Though NAFLD and NASH are largely asymptomatic, RUQ pain occurs in about one-third of NAFLD/NASH patients and varies in character and severity; some people report a mild aching fullness sensation, while others experience steady sharp pains that can disrupt their sleep.[i] Unfortunately, when patients report RUQ to their primary care providers, routine testing such as bloodwork or an ultrasound may not show anything wrong. With no physical indication that something is wrong or anything identifiable as the issue, pain may go unaddressed for years. If it is addressed, it isn’t uncommon for patients to be referred to psychiatric care, as if the RUQ pain were a symptom of a mental disorder as opposed to a physical disorder like NAFLD. This dismissal of RUQ pain as a symptom is unfortunate and means that the very real pain patients are experiencing is not taken seriously and that fatty liver disease that could have been caught earlier remains undetected.

As doctors always like to remind us, the liver itself has no pain receptors. It has been hypothesized that RUQ pain associated with and near the liver may be caused by distension of Glisson’s capsule, which surrounds the liver and has many pain receptors.[ii] In other words, people who have an abnormally large liver due to inflammation, steatosis, or fibrosis may be putting pressure on the liver capsule, which manifests as pain in the RUQ. As you can see in the microscopic liver picture below, Glisson's capsule is partially highlighted in green, and is a thin layer around the liver.

Though RUQ pain may be a sign of NAFLD or NASH, it may also be caused by other factors, so your doctor may only consider it a symptom if you are also experiencing unexplained fatigue or if you are a member of a population considered high-risk.[iii] That being said, it is one of the two more common symptoms that present in people with any stage of NAFLD/NASH. Even though NAFLD and NASH are mostly asymptomatic, RUQ pain could be a hint that you should consider thinking about your liver.

Some patients who are able to lose weight and reduce steatosis in their liver may experience reductions in RUQ pain as they continue to decrease their stress on the liver. Other patients are successful at losing weight and still experience RUQ pain. On the flip side, people who have been temporarily successful at changing their diets and lifestyles may have reductions in RUQ pain that reemerge when they revert to their old habits. Know that everyone’s bodies react to changes in weight and diet differently, so don’t be discouraged if your RUQ pain doesn’t immediately disappear once you have made lifestyle changes. Remember that lifestyle changes are truly a commitment for life—not temporary or quick fixes.

If you would like to read more about a patient's story involving RUQ pain, check out Terri's cautionary tale by clicking here.

[i] cancertherapyadvisor.com/home/decision-support-in-medicine/gastroenterology-hepatology/nonalcoholic-steatohepatitis-and-nonalcoholic-fatty-liver-disease/

[ii] cancertherapyadvisor.com/home/decision-support-in-medicine/gastroenterology-hepatology/nonalcoholic-steatohepatitis-and-nonalcoholic-fatty-liver-disease/

[iii] https://www.healthgrades.com/right-care/liver-conditions/5-signs-and-symptoms-of-fatty-liver-disease

PPAR -- Peroxisome proliferator-activated receptor

Lanifibranor by Inventiva leads the way

Wayne, you must be crazy to think I'll read something that starts out like that!!!

Be calm, I promise, it will make sense and if liver disease interests you this will be worth your time.

Therapies for NAFLD/NASH have been an elusive target and recent history is littered with promising molecules that many thought were finally going to lead to treatments for our disease. This is not a trivial problem. People are dying and our weapons are coffee and vitamin E.

Don't get on me about lifestyle right now.  I know that tune but I also connect through our peer groups with thousands of people who need more than that and drugs will be part of a proper management of this disease if we can ever find something that works.

Becky Taub and Paul Friedman, the founders of Madrigal Pharmaceuticals, are heroes of mine.

There has been a lot of disappointing news about NAFLD/NASH therapy research this past year.  I thought you might enjoy a look at some new data that is very encouraging. Terns Pharmaceutical just reported very positive 12 week results of the drug TERN-101. Below is a chart from their report about changes in results using a fairly new non-invasive test by Perspectum, the Liver MultiScan measuring a value called cT1 or corrected T1.  I'll explain it a bit later but for the moment just know that it is an indirect measure of fibrosis.  Click the image to see a larger view.  As a phase 2 study this is a small number of patients but the effect on their livers in only 12 weeks is among the best early data that we have seen.

We all know the issues. Too much disease, no treatments, a looming health crisis made worse by the pandemic. We are here on International NASH day and it seems like an apt time to wonder if there might be a better way.  If you haven't registered for the event I invite you to do so by clicking on the image below, but I also invite you to think about the future of research and how we as patients can support a better way.

CLICK HERE to view the recording of Wellness Webinar Part 3

Welcome to Fatty Liver Foundation's Wellness Webinar Series. This six-part webinar series will deliver the latest research and medical information to people living with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) and their medical providers. Our goal is to keep the patient community up-to-date on medical research and to build an archive of the important historical evolution of the field, while creating a space for patients to have their questions answered by top experts.

FLF believes independent, clear, timely, and accurate information is vital for empowering patients to help them develop self-awareness, self-care, make informed decisions about participating in clinical trials, and promote understanding that patients can be equal partners in their healthcare decisions.

Are you ready to join us for part-three of the FLF Wellness Webinar Series? This installment of the series will be brought to you by our Moderator Dr. Neeraj Mistry and a panel of patients who will be discussing the impact of COVID-19 on patients with liver disease. The session will be in a fireside chat format with the chance to answer your questions. This webinar will be limited to 100 registrants, sign up today to secure your spot!

We look forward to your participation!

Host: Wayne Eskridge, Co-Founder and CEO, Fatty Liver Foundation
Moderator: Neeraj Mistry, MD, MPH, Chief Medical Officer, Fatty Liver Foundation
Panelists: Terri Milton, Meagan Paullin, Tony Villiotti

I remember Google before it became mostly an advertising farm.  To be able to get to information easily was magic. Today no matter where you go it is a parade of ads and cleverly designed hustles. Like search, now that video is so easy to do, the webinar world has exploded with ads. Since we don't sell anything and our only interest is having you not die of liver disease, getting past all the noise so that you might consider joining us is a real challenge.

Velacur

What it measures: fibrosis, steatosis
Who should take it: undiagnosed and diagnosed NAFLD/NASH patients
Where to get it: certain primary care providers, specialty centers, and hospitals; clinical trials 

Velacur is an imaging-based diagnostic test developed by SonicIncytes that looks at liver fibrosis (stiffness, scarring) and steatosis (fat) using ultrasound technology. Velacur can be used to help diagnose and monitor NAFLD/NASH and is a quick and comfortable procedure. Velacur uses technology similar to MRI elastography, using multiple frequency steady-state waves to generate a 3D liver tissue sampling.[1] The images produced are enhanced by machine-learning and multiple clinical studies have demonstrated consistently high correlation to MRI for measuring steatosis and fibrosis.[2]

Your physician or a trained technician perform the procedure on you while you are lying down, placing a gently vibrating pad under the right side of your back and running an ultrasound probe over your ribs to scan your liver. The entire process takes only about 5 minutes and results are immediately available.[3]

Results from a Velacur reading can be seen in the image below. The two main results from the scan are elasticity and attenuation. Elasticity is a measure of fibrosis and attenuation is a measure of steatosis. Together, these scores will allow your provider to diagnose and monitor the severity of your NAFLD/NASH.

In comparison to transient or ultrasound elastography, Velacur’s advantages are deeper tissue measurement, larger tissue sampling, 3D data acquisition, using a single probe for all body types, fewer user readings required, machine-learning enhanced image guidance, and greater comfort.[4] In comparison to other diagnostic tools, Vealcur is the most cost-effective and has the advantage of not requiring pre-approval from insurance.[5]

[1] SonicIncytes, Products, https://www.sonicincytes.com/products/

[2] SonicIncytes, Products, https://www.sonicincytes.com/products/

[3] SonicIncytes, Patient Brochure, https://sonicincytes.com/wp-content/uploads/2020/12/SI_VelacurBrochure_WEB.pdf

[4] SonicIncytes, Technology, https://www.sonicincytes.com/technology/

[5] SonicIncytes, Products, https://www.sonicincytes.com/products/

By Gabriella Wan

CBD, or cannabidiol, is a non-psychoactive component of the cannabis plant with anti-inflammatory properties.[1]  To ensure avoidance of psychoactive effects, CBD must be extracted from hemp, not traditional marijuana.[2] In recent years, CBD has become a popular supplement. CBD works in the body through the endocannabinoid system, which is highly upregulated during chronic liver disease, affecting multiple steps along the disease’s progression.[3]

Some research has been done concerning the interactions between CBD and liver disease, with mixed but promising results. The first thing to understand about CBD is that there are two important related receptors in our bodies, called CB1 and CB2. As noted in a 2008 study, cannabinoid receptors (CB1 and CB2) and their binding molecules (endocannabinoids) have emerged as novel mediators of liver diseases. While activation of CB1 receptors can contribute to NAFLD and fibrosis, activation of CB2 receptors have been characterized as antifibrogenic and regulators of inflammation.[4] With this understanding, it makes sense that inhibiting CB1 receptors has been shown to inhibit the progression of fibrosis, while activating CB2 receptors has been shown to inhibit growth and cause cell death for cultured liver fibrogenic cells. Because CB1 and CB2 receptors exert opposite effects on liver fibrosis, evaluating the net impact of using endocannabinoid signaling on liver fibrosis in a clinical setting is complicated and far from clear cut.[5]

“EC receptors expression and functions in the liver. Cannabinoid receptors CB1 and CB2 are expressed in all liver cell types at different basal levels. Both receptors are upregulated during chronic liver damage and mediate opposite functions: CB1 promotes and CB2 protects from liver damage. The experimental and clinical evidences indicate CB1 as a stronger player, contributor and an attractive target in the development of CLD. Abbreviations: ALD, alcoholic liver disease; HCC, hepatocellular carcinoma; NASH, nonalcoholic steatohepatitis; PBC, primary biliary cirrhosis; PSC, primary sclerosing cholangitis; TG, triglyceride; VLDL, very low density lipoprotein.”[6]

In animal tests, the relationship between CB1 receptors and fatty liver (both diet-induced and obesity-associated) has been made clear. Research has shown that high-fat diets induce fatty liver via activation of CB1 receptors, which are necessary for the development of diet-induced steatosis, dyslipidemia, and insulin resistance.[7] Studies with obese rats have shown that the administration of CB1 inhibitors reduced obesity-associated hepatic steatosis and certain features of metabolic syndrome.[8] The drug Rimonabant was the first selective CB1 inhibitor used in clinical practice after clinical trials showed its benefit on weight reduction, abdominal obesity, liver steatosis, and other cardiometabolic syndromes.[9] Though this may seem like good news, it is important to note the increased appearance of psychiatric disorders including depression, anxiety, irritability, and aggression.[10] Consequently, the FDA never approved Rimonabant for the treatment of obesity.

While we have lots of research on CB1 receptors and fatty liver, investigations regarding the role of CB2 receptors in this disease area are minimal. In human studies, liver samples from patients with steatosis and steatohepatitis have expressed CB2 receptors, while liver samples from normal livers showed no CB2 receptor expression.[11] In fibrogenesis, CB2 activation has exhibited some evidence of an anti-fibrogenic role.[12] In rats, studies have shown that activating CB2 receptors in the liver significantly reduced collagen content in rats with pre-existing cirrhosis and improved regenerative response to acute liver injury.[13] It is important to note that other studies have shown conflicting results regarding CB2 and NAFLD.[14]

While you should always consult with your doctor before starting to use any supplement, CBD has some special considerations. If you decide to take it even though the jury is still out on the effects of CB1 and CBD on NAFLD, please be cautious of the following things:

• Dosage
  • The amount of CBD recommended for therapeutic use in humans ranges from 0.5mg/kg/day to 20mg/kg/day.[15]
  • FDA hasn’t created any measures to regulate CBD products, so potency labels can be inaccurate.
• Quality
  • FDA hasn’t created any measures to regulate CBD products, so they may be contaminated or misrepresented.
  • To find safe and reputable products, make sure the company has third-party lab testing, good reviews, and transparency for its products (including sourcing, extraction methods, packaging, and return policies).
• Interactions with other medications being processed by CYP450 family of liver enzymes
  • Many conventional doctors do not know much about CBD since it’s not taught in medical school, so it may be best to ask them if any of the drugs you’re taking are affected by eating grapefruits, since grapefruit also affects the same liver functionality.[16]

Gabriella Wan is a Program Coordinator at the Fatty Liver Foundation with a background in public health. She is passionate about improving quality of life through lifestyle change, awareness raising, and education.

Sources

[1] Avraham, Y, et al, Cannabidiol improves brain and liver function in a fulminant hepatic failure-induced model of hepatic encephalopathy in mice, British Journal of Pharmacology, April 2011, doi: 10.1111/j.1476-5381.2010.01179.x

[2] Tesséra Naturals, Does CBD cause liver damage?, CBD Education, August 2020, https://tesseranaturals.com/does-cbd-cause-liver-damage/

[3] Mallat, A and Lotersztajn, S, Endocannabinoids and liver disease. I. Endocannabinoids and their receptors in the liver, American Journal of Gastrointestinal Liver Physiology, January 2008, doi: 10.1152/ajpgi.00467.2007

[4] Mallat, A and Lotersztajn, S.

[5] Mallat, A and Lotersztajn, S.

[6] Patsenker, E and Stickel, F, Cannabinoids in liver diseases, Clinical Liver Disease, February 2016, doi: 10.1002/cld.527

[7] Osei-Hyiaman, D, et al, Hepatic CB1 receptor is required for development of diet-induced steatosis, dyslipidemia, and insulin and leptin resistance in mice, Journal of Clinical Investigation, September 2008, doi: 10.1172/JCI34827

[8] Gary-Bobo, M, et al, Rimonabant reduces obesity-associated hepatic steatosis and features of metabolic syndrome in obese Zucker fa/fa rats, Hepatology, July 2007, doi: 10.1002/hep.21641

[9] Christopoulou, FD and Kiortsis DN, An overview of the metabolic effects of rimonabant in randomized controlled trials: Potential for other cannabinoid 1 receptor blockers in obesity, Journal of Clinical Pharmacy and Therapeutics, February 2011, doi: 10.1111/j.1365-2710.2010.01164.x

[10] Christopoulou, FD and Kiortsis DN

[11] Mendez-Sanchez, N, et al, Endocannabinoid receptor CB2 in nonalcoholic fatty liver disease, Liver International, March 2007, doi: 10.1111/j.1478-3231.2006.01401.x

[12] Julien, B, et al, Antifibrogenic role of the cannabinoid receptor CB2 in the liver, Gastroenterology, March 2005, doi: 10.1053/j.gastro.2004.12.050

[13] Muñoz-Luque, J, et al, Regression of fibrosis after chronic stimulation of cannabinoid CB2 receptor in cirrhotic rats, Journal of Pharmacology and Experimental Therapeutics, November 2007, doi: 10.1124/jpet.107.131896

[14] Dibba, P, et al, Mechanistic Potential and Therapeutic Implications of Cannabinoids in Non Alchoholic Fatty Liver Disease, Medicines, May 2018, doi: 10.3390/medicines5020047

[15] Curley, Christopher, Worried About CBD Hurting Your Liver? Here’s What the Experts Have to Say, healthline.com Health News, August 2019, https://www.healthline.com/health-news/can-cbd-hurt-your-liver-what-to-know-about-a-new-study?c=672391731507

[16] Tesséra Naturals.

      +     

The physician resource Healio.com has interviewed FLF CEO and Co-Founder Wayne Eskridge twice. We hope that sharing Wayne's experience as a patient with the physician community may help in changing the landscape towards more patient-centered care. If you are interested in watching the short interviews, they can be found at the links below.

The first interview was conducted at the International Liver Congress in Vienna, Austria in 2019. In this video, Wayne discusses the need for physicians to support patients who are engaged in their health care. To watch click here. 

The second interview was conducted over Zoom in 2021. In this video, Wayne speaks about FLF's recent efforts to help blunt the epidemic of liver disease and how the Foundation's goals for this year have been shaped by the COVID-19 pandemic. To watch click here.

FibroScan

What it measures: fibrosis, steatosis
Who should take it: undiagnosed and diagnosed NAFLD/NASH patients
Where to get it: specialty care centers, hospitals, some primary care providers

FibroScan is an imaging-based diagnostic test developed by Echosens that looks at liver fibrosis (stiffness, scarring) and steatosis (fat) using transient-elastography technology. FibroScan can be used on patients in need of staging of their NAFLD/NASH, whether their condition is suspected or biopsy-confirmed. FibroScan works similarly to an ultrasound, emitting a small pulse of energy, called a shear wave. The speed of the shear wave is measured as it travels through your liver, generating two scores to determine overall liver health. The first score measures liver stiffness and the second score measures liver fat. In combination, these scores can help you understand your overall liver health and how it may change over time with lifestyle or medical interventions.[1] The only thing you will feel while taking the test is a light vibration on your skin and the entire procedure takes less than 10 minutes.

Depending on where you get a FibroScan may determine the scoring system used in your diagnosis. Typically, a 5-pointscoring system is used to grade the degree of liver fibrosis, from F0-F4. Scores from the FibroScan will be in kilopascals (kPa), ranging from 2 to 75 kPa. Normal livers fall between 2 and 6 kPa, with anything outside this range indicating some degree of liver disease.[2] The table below, adopted from MSK, considers different scores in the context of different liver diseases and can be used to help determine fibrosis score. It is important to remember that the ranges in the table are estimates, and your actual fibrosis score may not match what the table says. When determining your actual fibrosis score, in addition to your fibrosis measurement, your provider will take into consideration your health history and the grade of steatosis.

To use the table, find the liver disease that you have on the left side of the table. Read across the row from left to right until you find the range that includes your fibrosis result. Then, look at the top of that column to see the fibrosis score.[3]

FibroScan has been in available in the European market since 2003 and was expanded to China, Canada, Brazil, Japan, and many other countries before being approved by the FDA in 2013.[4] It is reimbursable by insurance. To find a location near you with a FibroScan machine, use Echosens’ locator, which can be found here.

[1] Echosens, For Patients, https://echosens.us/for-patients/

[2] Memorial Sloan Kettering Cancer Center, Understanding Your FibroScan Results, February 2018, https://www.mskcc.org/cancer-care/patient-education/understanding-your-fibroscan-results

[3] Memorial Sloan Kettering Cancer Center

[4] Echosens, FDA Approves FibroScan® for Non-invasive Liver Diagnosis, April 2013, https://www.prnewswire.com/news-releases/fda-approves-fibroscan-for-non-invasive-liver-diagnosis-203186961.html#:~:text=%2D%20Echosens%E2%84%A2%20is%20pleased%20to,technology%20in%20the%20United%20States.

We are partnering with Johns Hopkins on a COVID-19 project vital to patients with NAFLD/NASH. As you know, we have been critical of the vaccine developers and the CDC for not engaging patients with liver disease. We want to know what to expect from this vaccine and the only way to find out is to do the testing.

We are pleased to announce a clinical trial for patients with diagnosed liver disease. It is very important that we as patients support this effort. It means having several blood tests but we are used to that and most importantly we can find out just how well the vaccine protects us. The link to sign up is below. I urge you to participate.

Enhanced Liver Fibrosis (ELF) Panel

What it measures: fibrosis

Who should take it: diagnosed NAFLD/NASH patients

Where to get it: Europe

The Enhanced Liver Fibrosis (ELF) panel, is a blood test developed by Siemens Healthineers that measures fibrosis using serum markers. Though this test is not commercially available in the United States, ELF is typically used to assess the risk of progression to cirrhosis and liver-related clinical events, most commonly to diagnose advanced fibrosis, ≥F2, in patients with NAFLD/NASH.[1]

The ELF test is a panel of three biomarkers: type III procollagen peptide (PIIINP), hyaluronic acid (HA), and tissue inhibitor of metalloproteinase-1 (TIMP1). These values are summarized into a single score, which can be compared to different thresholds for diagnosis. The thresholds recommended by Siemens are 7.7 (lower threshold) and 9.8 (higher threshold). Meta-analysis has shown that the lower threshold of 7.7 had a sensitivity of 0.93 and a specificity of 0.34; this means that 93% with advanced fibrosis will be identified, while 34% of those without advanced fibrosis will be identified.[2] The higher threshold of 9.8 showed a specificity of 0.86 and a sensitivity of 0.65; this means that 86% of those with advanced fibrosis will be identified, while 65% of those without advanced fibrosis will be identified. As you can see, the lower threshold ensures that more people with advanced fibrosis will be accurately identified, at the expense of accurately identifying those without advanced fibrosis.

Interestingly, the National Institute for Health Care and Excellence (NICE), a guideline-publishing public health body in England, sets the threshold for ELF at 10.51. At this value, ELF demonstrates a specificity of 0.93 and sensitivity of 0.51.[3] In other words, a cutoff of 10.51 means that 93% of those with advanced fibrosis will be identified and 51% of those without advanced fibrosis will be identified.

While it is important to consider the effects of these various thresholds, the prevalence of advanced fibrosis in a population also has a significant impact. How much advanced fibrosis is present in a population determines which threshold should be used. In settings with a low prevalence, ELF is a useful tool to rule out NAFLD/NASH patients from having advanced fibrosis and less certain when trying to rule in advanced cirrhosis. At a prevalence >30%, the ability of the test to accurately identify those with advanced cirrhosis is much lower.[4]

[1] Vali, Yasmin et al., Enhanced liver fibrosis test for the non-invasive diagnosis of fibrosis in patients with NAFLD: A systematic review and meta-analysis, Journal of Hepatology, April 2020, doi: https://doi.org/10.1016/j.jhep.2020.03.036

[2] Vali et al.

[3] Vali et al.

[4] Vali et al.