May NASH News
Fatty liver disease (FLD) and non-alcoholic steatohepatitis (NASH) are increasing in prevalence worldwide, creating a major global public health crisis. To adequately educate patients, practitioners and policy makers, there is a need to collect, curate and share relevant information. NASH News, published on behalf of the Global Liver Institute’s NASH Council, intends to meet that need and to facilitate collaboration across the emerging NASH community on a monthly basis.
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International NASH Day, June 12, 2019
Non-alcoholic steatohepatitis (NASH) has been called an epidemic, a ticking time bomb, and a silent tsunami. It is the progressive form of non-alcoholic fatty liver disease (NAFLD), and affects more than 115 million people worldwide. An estimated 357 million people will be affected by 2030.
Because NASH symptoms are not overt, NASH is often underdiagnosed and underreported. NAFLD and NASH are major risk factors for concurrent conditions: more than 70% are obese, up to 75% have type 2 diabetes, and anywhere from 20-80% have hyperlipidemia. Unchecked, NASH may lead to cirrhosis, liver cancer, and liver transplant.
Against this backdrop, the first International NASH Day (IND) was launched on June 12, 2018, with the goal of raising awareness about NASH and the actions people can take to prevent the disease. The program successfully launched events, briefings, media outreach, and social media interactions globally. Now under the Global Liver Institute’s leadership, International NASH Day is set to build off last year’s successes.
For 2019, International NASH Day will again be held on June 12th, but this year it will also serve as a kick-off for awareness and education initiatives year round.
For those in Washington, I would like to highlight a local IND launch event, a Capitol Hill Briefing titled, The Rising Risks of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH). This educational briefing will be held from 12:00-1:00PM in Senate Russell 188, June 12, 2019. Other events in New York City, Brussels, Mexico City, Moscow and elsewhere globally will soon be listed on our website with more details in the near future.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
This Perspective was first published in the May 2019 issue of GLI’s Liver Health Policy Update
International NASH Day Events Slated Around the World!
Join GLI and stakeholders worldwide as we mark International NASH Day on June 12.
Promote on social media: Follow @globalliver and @intNASHday on Twitter and /intNASHday and /globalliver on Facebook.
Host an event on or around June 12. An ideal event has the following components:
Linkage to care/clinical trials information
Entertainment or “wow” factor such as spokesperson appearance or film screening
Invitations to policymakers and press
Use of IND social media hashtag #NASHday
Would you like to be recognized as an International NASH Day sponsor? Contact firstname.lastname@example.org.
Patients Share Their NASH Stories
How do people learn they have NASH? What effect has it had on their lives? How do patients feel and what is their outlook? Answers to these and other questions are being provided by NASH patients from around the world who are clicking on “Take Action” and “Share Your Story” on the International NASH Day website. Story snippets from last year are already available and GLI will be posting complete statements very soon. All are anonymous. Here is one from the United States:
I was diagnosed with NASH 3 years via biopsy by me being my own advocate. I felt something was not right. I was having symptoms and every test was coming back normal except my liver enzymes . I was bloating so bad I looked 6 months pregnant and had a constant pain from under my right rib cage that I now felt in my back. I now suffered a daily itch all over my body. I was diagnosed with fatty liver 20 years ago and always told it’s common, just lose weight and exercise. The ultrasound showed fatty liver like always but this time an MRI was ordered because a cyst was seen on the ultrasound. The MRI came back a 3cm fluid filled cyst- no surgery needed. It would dissolve on its own. Eat healthy and exercise, that(s) all you can do (I was told). I was frustrated by that point and demanded a biopsy.
At that time, I was down 50lbs and walked 5 miles a day and on Sundays hiking 10 to 15 miles. Yes, I was still overweight but in my best health. I did finally get the biopsy and I was diagnosed as NASH stage 0-1 fibrosis. I showed very mild fibrosis and my new gastroenterologist said I was on the fence and at a stage (where) it was reversible. Eat a clean diet, no preservatives, no prepackaged foods, exercise, only two glasses of wine per week (I was told). The very first time I heard clean diet and no more than two lbs of weight loss per week. 20 years of all kinds of fad diets and eating prepackaged foods, not once have I been informed (of) the importance of a clean diet until that day. I walked away educated for the first time. I ate clean for a year and my symptoms subsided, my enzymes were normal. I thought, great, I’m better, I must have reversed it.
I injured my knee and there went my daily exercise and I started bad eating habits and put on 10 lbs. My symptoms returned and I kept coming across ads for NASH liver pharmaceutical studies and I found one near me. I thought I wouldn’t be accepted since they were looking for NASH patients with stage 2-3 fibrosis with no chronic liver disease. They did a biopsy along with a complete liver panel and MRI. I got the call and was so excited, I would take a drug that may help me. After I signed all the consents and started my medication, it finally hit me that I qualified because I met their requirements. I’m now a stage 2-3 fibrosis; how did that happen so fast? It’s been less than two years since my initial biopsy.
(At) my next appointment with my study doctor I had so many questions. I can say I have a great study doctor and team. I am now 6 months into the study. The hardest part of this disease is that there is no current treatment and my family’s reactions. Because I do not look physically sick, some just can’t believe the seriousness of the disease. My son who researches everything has taken the news the hardest due to statistics of life expectancy. The hardest part is coming home after getting certain results and trying to keep a poker face when a recent Fibroscan test came back showing advanced fibrosis. It’s not an easy disease to live with and primary care doctors need more education on NASH. I know now being overweight, having diabetes, PCOS, and insulin resistance contributed to my NASH. Every day is a struggle, just because I feel better does not mean (I should) stop eating clean. I hope the study helps me and if it doesn’t I hope I contributed to a future treatment regimen for NASH. I pray for a cure one day soon.
Editor’s Note: These are the exact words of the submitter. GLI has added words in parentheses, added punctuation where helpful and/or corrected typos or spelling errors.
In March, GLI submitted a letter to the U.S. Center for Medicare and Medicaid Services (CMS) formally recommending diagnostic coding changes to better distinguish stages of liver fibrosis. The coding standards are collected in a compendium known as the International Classification of Diseases and Related Health Problems, 10th edition (ICD-10). GLI’s presentation stressed that revisions to the coding are necessary to enable liver fibrosis to be classified more accurately and more consistently with current clinical perspectives and documentation, particularly for nonalcoholic steatohepatitis (NASH).
GLI’s proposal was discussed at a subsequent meeting of the ICD-10 Coordination and Maintenance Committee and then was posted for public comment, which ended May 10, 2019. The following organizations submitted their own comments in support of GLI's proposal:
American Association for the Study of Liver Disease
American Gastroenterological Association
Fatty Liver Foundation
Gilead Sciences, Inc.
Individual patient alumni of GLI’s Advanced Advocacy Academy (A3)
Obesity Action Coalition
GLI had created talking points to provide background that could assist in the creation of submission by other liver advocates.
GLI Releases Beyond the BiopsyTM Campaign Statement
Beyond the BiopsyTM is the Global Liver Institute’s new awareness campaign, dedicated to accelerating the acceptance and adoption of noninvasive technologies as an alternative to biopsy. Read our brief program description and learn how you can get involved.
A3 Alum Creates NASH Education Program
Global Liver Institute is now recruiting for its third class of liver patients for advocacy training. Called Advanced Advocacy Academy (A3), GLI has trained more than 40 patient advocates from the U.S. and applicants from around the world.
A 2018 grad, liver patient Tony Villiotti and his caregiving wife Betsy, have created a NAFLD and NASH education program in Pittsburgh, PA, working with local hospitals and patients. They are creating a documentary and Tony, an engineer, has also drafted a “roadmap” (an algorithm) as an educational aid. Additionally, by working with a communications company, they were able to create a billboard to further generate awareness about NASH.
NASH Research & Development
Experts Warn of Fatty Liver Disease 'Epidemic' in Young People
A large population-based study in the UK has revealed that one in five of 4,000 young adults studied has steatosis (fatty liver), and that one in 40 of these has already developed fibrosis. The Children of the 90s study, based at the University of Bristol, suggests that greater awareness of nonalcoholic fatty liver disease (NAFLD) is needed among young adults if a public health crisis is to be avoided.
EASL Releases Policy Recommendations at ILC 2019
EASL has released new policy recommendations on five key areas of European public health concern: obesity in NAFLD, liver disease in migrant populations, the screening of blood donations for hepatitis E virus, elimination of hepatitis C, and reducing the burden of alcohol-related liver disease.
HIV-Infected Individuals at High Risk of NAFLD
Two studies highlighted the increasing burden and risk of NAFLD associated with HIV infection. These studies found that, while prevalence and mortality rates associated with viral hepatitis in individuals infected with HIV have been declining, rates associated with NAFLD are increasing, leading to a risk of progressive liver disease.
U.S. Public Policy
U.S. House of Representatives Includes NAFLD and NASH Language in Appropriations Report
For the first time, NAFLD and NASH have been included in the U.S. House Committee on Appropriations report, and the Fiscal Year 2020 report includes directive language to the CDC (page 63):
“Fatty Liver Disease—The Committee recognizes that the prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis is growing dramatically in the U.S. The Committee encourages CDC to develop prevention, education, diagnosis, and treatment programs to combat existing incidence and provide appropriate prevention activities to mitigate further increases.”
NASH Council Members in the News
The prevalence of obesity, measured by body mass index, has risen to unacceptable levels in both men and women in the United States and worldwide resulting in hazardous health implications. Genetic, environmental, and behavioral factors influence the development of obesity, and both the general public and health professionals stigmatize those who suffer from the disease.
Liver Forum Publication Addresses Clinical Trial NASH Endpoints
The Liver Forum has announced that the second manuscript prepared by its Case Definitions Working Group has been accepted by Hepatology. The publication, “Defining improvement in nonalcoholic steatohepatitis for treatment trial endpoints: Recommendations from the Liver Forum, can be read online.
Genfit Phase 3 Elafibrinor Clinical Trial Achieves Safety Milestone
Genfit announced that the Data Safety and Monitoring Board has recommended continuation of the company’s RESOLVE-IT clinical trial without modification. Elafibranor is an oral, once-daily, drug developed to treat nonalcoholic steatohepatitis (NASH).
Intercept Pharmaceuticals released results from the phase 3 REGENERATE clinical trial showing obeticholic acid improves liver fibrosis, scarring, and other difficulties of NASH. "This is a watershed moment," said Zobair Younossi, MD, from Virginia Commonwealth University in Fairfax. "It's the first trial that shows efficacy for NASH."
Gilead Sciences and Novo Nordisk announced they intend to collaborate on a clinical trial combining compounds from their respective company drug development pipelines in NASH. The intended clinical trial will be a proof of concept study combining Novo Nordisk’s semaglutide (GLP-1 analogue) and Gilead’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the treatment of patients with NASH.
Fact of the Month
Nonalcoholic fatty liver disease (NAFLD) costs the United States healthcare system $32 billion annually. For comparison purposes, stroke costs the United States about $34 billion annually.