Fatty liver disease (FLD) and nonalcoholic steatohepatitis (NASH) are increasing in prevalence worldwide, creating a major global public health crisis. To adequately educate patients, practitioners, and policymakers, 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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I had the opportunity to participate in the NASH-TAG 2022 Conference in Park City, Utah. Thank you to course directors Michael Charlton, MBBS, FRCP; Vlad Ratziu, MD; Stephen Harrison, MD, and Rohit Loomba, MD, MHSc for setting a standard for high-quality scientific presentations, and even higher expectation and tone for collaboration and innovative thinking.
As a liver patient involved in the field professionally in clinical trial recruitment, regulatory affairs, and health system innovation for two decades here are my takeaways:
- We have an opportunity to reset in 2022. Take the lessons learned, good and bad, in drug development and choose what we will do from this point forward.
- Biopsy is misapplied to this disease (or set of diseases). Should patients be expected to take a test we cannot accurately, dependably interpret? Artificial intelligence (AI) will help, but we should be brave enough to address the foundational issue.
- Focus on endpoints that are achievable and have meaning to patients, such as non-progression (which has models in other liver diseases like primary sclerosing cholangitis (PSC)
- Secure commitment from our regulatory partners when we meet the agreed upon endpoints that will be sufficient for approval.
- Standardize the standard of care for placebo groups.
- Let’s not gloss over what we know does work – 7-10% weight loss – and continue both research in those therapies that induce that level of weight loss and facilitate patient access to all methods, services, and treatments.
- Take action in the timeframe that reflects the urgency of patients; hundreds of whom are progressing to cirrhosis, cancer, and transplant every day.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
Global Liver Institute and TriSalus Life Sciences Partner To Launch “Liver Central,” a New Resource Hub for Liver Cancer Researchers, Clinicians and Patients
The Global Liver Institute (GLI), the only patient-led liver health nonprofit operating internationally, in partnership with TriSalus Life Sciences®, an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors, announced the launch of Liver Central, a comprehensive online guide for all things related to liver cancer. Learn more about the educational resources offered through Liver Central at livercentral.org.
Become a Partner or Sponsor for International NASH Day – June 9, 2022
Global Liver Institute (GLI) is pleased to announce that the 2022 International NASH Day (#NASHday) will be held on June 9, 2022! Please join us in a global effort to raise awareness about NASH and the actions that people can take to address this life-threatening disease worldwide. Last year, we transformed #NASHday into an engaging multi-platform experience, convening 120 IND partners from 73 countries and 33 remarkable international speakers to declare the urgency of combating the parallel epidemics of NASH and COVID-19. Contact NASH@globalliver.org for more information.
View the 2021 NASH Day Summary Report
Surfing the NASH Tsunami
Every week, a global community of fatty liver disease stakeholders comes together to explore the most important challenges in diagnosing, treating, and developing medications for patients. Catch the latest episode of Surfing the NASH Tsunami featuring commentary from GLI Founder and CEO, Donna Cryer, on Day 1 of the recent NASH-TAG Conference 2022, held January 6-8.
Join GLI President and CEO, Donna Cryer in conversation with world experts in policy, research, clinical care, and wellness as they put liver patients and the challenges they face front and center. Join GLI LIVE with your questions on Facebook, Twitter, or GLI’s YouTube channel every Wednesday at 12 PM ET.
Upcoming GLI Events
February 3: NASH Council Policy Working Group. Contact Andrew Scott for more information
February 4: PBC Externally-Led Patient-Focused Drug Development Symposium. Contact Andrew Scott for more information
March 3: NASH Council Policy Working Group. Contact Andrew Scott for more information
May TBD: NASH Council Meeting. Contact Jeff McIntyre for more information
June 9:International NASH Day. Contact NASH@globalliver.org for more information
How do people learn they have NASH?
The excerpt below is taken from a patient story featured on our International NASH Day website. Read the patient’s full story.
“I was diagnosed with NASH 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 six months pregnant and had a constant pain from under my right rib cage that I now felt in my back. I was diagnosed with fatty liver 20 years ago and always told it’s common…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… 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 thought, great, I’m better, I must have reversed it.”
GLI Partner Highlight
GLI is pleased to welcome Madrigal Pharmaceuticals as one of the newest members of the GLI NASH Council. Madrigal Pharmaceuticals, is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver. The company has advanced its lead candidate, resmetirom, (also known as MGL-3196) through Phase 2 clinical trials in NASH and are expecting it to demonstrate multiple benefits across the broad spectrum of NASH and NAFLD patients.
Research & Development
Can Non-Invasive Medical Devices Help Speed Intervention in Liver Disease?
Studies show that detecting and monitoring liver disease using vibration-controlled transient elastography (VCTE) is a non-invasive, convenient, and cost-effective way for clinicians to quantify the stiffness of liver tissue and to estimate liver fat at the point of care. VCTE also offers consistent results to enable clinics to monitor fatty liver disease and provide feedback to patients about their diet and lifestyle modifications. Read more
GLI NASH Resources
NAFLD/NASH: How Can Patients Participate in Clinical Trials
GLI recently released a guide to participating in clinical trials for patients with NAFLD/NASH. NAFLD/NASH: How Can Patients Participate in Clinical Trials is a comprehensive resource that provides answers to your questions about clinical trials for NAFLD/NASH patients and caregivers – what they are, why they are important, questions to ask, and where to find them. Coming soon in French and Spanish.
2021 U.S. NASH Action Plan Scorecard
This year-end scorecard lists the accomplishments achieved according to the detailed agenda in the U.S. NASH Action Plan for each relevant stakeholder group — patients/carepartners, clinicians, medical societies, patient advocacy organizations, industry, payors, health systems, regulators, and policymakers. While gaps and challenges remain, tracking and acknowledging NASH successes according to the U.S. NASH Action Plan is pivotal for the field to respond on a national scale in 2022 and beyond.
U.S. NASH Action Plan
GLI and the GLI NASH Council released the U.S. NASH Action Plan to comprehensively address NASH and its impact on patients and families, public health, and the economy. It includes a set of actionable recommendations for the full spectrum of groups involved in NASH prevention and treatment.
NASH Core Curriculum: A Comprehensive Online Resource Center
GLI, in collaboration with Clinical Care Options, launched the CME course, NASH Core Curriculum: A Comprehensive Online Resource Center to improve clinician understanding of foundational concepts in NASH diagnosis, management, and emerging pharmacologic treatment strategies. Resources are developed primarily for clinicians, including advanced practice clinicians, in hepatology, gastroenterology, endocrinology, and primary care. The full curriculum includes CME/CE-certified video modules, ClinicalThought™ expert commentaries, and downloadable presentations and resources. NASH Core Curriculum is supported by educational grants from Gilead Sciences and Novo Nordisk Inc.
GLI Nutrition App with NutriStyle
GLI and NutriStyle Inc. have partnered to create a personalized nutrition app for people living with liver disease, diabetes, and other chronic conditions or who want to maintain good liver health. The app will create personalized meal plans to meet the specific requirements set out by GLI nutritional advisors for people with NASH or a general interest in liver health. Visit NutriStyle to learn more.
Reaching At-Risk Patients Through COVID-19 Vaccination Sites
GLI launched a collaborative effort with Summit Clinical Research to promote NASH awareness in the context of liver health and COVID vaccination via partnerships through city vaccination sites and direct patient education. Providers will be giving people who have just received their COVID-19 vaccination our new resource, After Your COVID-19 Vaccination, Take the Next Step for Your Liver. Please contact NASH@globalliver.org if you would like to share this resource through a COVID-19 vaccination site.
Millions are suffering from diet-related diseases. What number will make us pay attention?
A recent analysis from the Rockefeller Foundation on “The True Cost of Food” said the nation spends $1.1 trillion on food, and loses another $1.1 trillion in health-care spending and lost productivity attributable to diet-related diseases. Read the article
Educational Interventions Are Needed to Address Knowledge Gaps for Management of NASH
While hepatologists and other specialists make most NASH diagnoses and are the primary care coordinators, there is a need for educational interventions to address knowledge gaps. Read more about the two posters presented at The Liver Meeting Digital Experience (TLMdx) addressing areas of unmet need among specialists.
More Seniors Need Liver Transplants, Often Due to NASH
A new study has revealed that the proportion of older people requiring a liver transplant has greatly increased, likely due to the concurrent rise in NASH. “In the past, older patients were routinely denied listing for liver transplantation because doctors believed they were less likely to survive the surgery and post-transplant management…age limits are largely being abandoned as exclusion criteria.” Maria Stepanova, PhD, Center for Outcomes Research in Liver Diseases, said in a press release.
Current Clinical Trials
Clinical trials are at the heart of all medical advances. The goal of clinical trials is to determine if a new test or treatment works and is safe as well as other aspects of care, such as improving the quality of life for people with NAFLD or NASH. Since there are currently no medications approved for the treatment of NAFLD or NASH, clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.