NASH News December 2019
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.
We would appreciate your feedback and content contributions. Please contact nash@globalliver.org
GLI Perspective
This month, the Global Liver Institute (GLI) is excited to introduce its NASH Program Director, Jeff McIntyre, who joined us this autumn. The December GLI Perspective comes from Jeff, who provides the outlook for growing GLI’s NASH programs and the need for patient’s voices at all stages of NASH and NAFLD.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
Jeff McIntyre - GLI NASH Program Director, GLI Guest Perspective
Jeff McIntyre, GLI NASH Program Director
I’m Jeff McIntyre and am excited to join the Global Liver Institute as the NASH Program Director. It has been an exciting running start with GLI. I met many of you during a full fall schedule of meetings, including the recent AASLD Liver Meeting where Global Liver Institute staff were selected to participate in 3 committees:
Donna Cryer, JD - AASLD Patient Advisory Committee, AASLD NAFLD Task Force
Andrew Scott - AASLD Policy Committee
Jeff McIntyre - AASLD Practice Guidelines Committee
I met others at GLI’s successful Hill Day and Advanced Advocacy Academy in Washington. I was also part of Global Liver Institute staff who, in one day, presented in-person at meetings in 3 different countries - the United States, England, and Germany. The request and need for patient input has never been as great as it is now. With our established NASH programs, GLI is leading the way in representing patient voices at all stages of engagement in liver disease.
Our goal with the NASH Council is to grow Council member’s capacity and effectiveness in addressing NASH. As the leading global liver patient advocacy organization, GLI presents a unique opportunity to bring stakeholders together to address the prevalence and incidence of NAFLD and NASH in a positive manner. In the upcoming months, we will be diving into our NASH Council workgroups - Clinical Workflow, Lifestyle, Policy, and Communications (New!) - to refine best practices, create a common language for patients and clinicians, and deliver solid policy recommendations.
I will be working with Livia Alimena, GLI’s European Office Director - who you met in the recent NASH News - to help coordinate International NASH Day (IND) on June 12, 2020. I am particularly excited about this as NASH and NAFLD are truly international concerns. While we work to expand the reach of International NASH Day, we also scale the work of the NASH Council to impact patients and at-risk populations around the world. As we see NASH and NAFLD incidences increase globally, GLI will work beyond borders to empower patients and at-risk populations.
I am honored to support the work of leaders and patients in the liver disease field, such as GLI President and CEO, Donna Cryer - and the growing team here at the Global Liver Institute. As Jane Goodall said, “What you do makes a difference. And you have to decide what kind of difference you want to make.”
Updates
Why do we Need a NASH drug? NASH Leaders Weigh in
There is no approved drug for nonalcoholic steatohepatitis (NASH), the buildup of fat in the liver that’s predominantly caused by obesity rather than alcohol misuse. But it irks hepatologist Tarek Hassanein, M.D. when people equate that to a lack of treatment options. “When someone says we don’t have anything to manage NASH—no, we have the key thing, which is lifestyle modification,” said Hassanein, a Professor of Medicine and Director of Outreach Services for liver transplantation at the University of California San Diego School of Medicine.
Coming Soon: NASH Treatment Approaching the Horizon
Physicians and patients can look forward to a very exciting future when it comes to NASH therapy. There are a number of cutting-edge options in mid-to-late stage development for NASH and NASH with fibrosis. Additionally, our understanding of the pathogenesis of the disease and our ability to detect disease activity through noninvasive testing are advancing incrementally at a rapid pace.
Using AI to Find a Less-Invasive Alternative to Liver Biopsy
Endocrinologists at Beth Israel Deaconess Medical Center (BIDMC) have developed a non-invasive test that can help doctors keep tabs on patients’ liver health. By measuring combinations of fats, hormones, carbohydrates and sugar molecules present in patients’ blood serum, the team of scientists used machine learning to develop models that can differentiate various stages of liver disease with near-perfect accuracy.
Riveting Story About Non-Alcoholic Fatty Liver Disease Debuts on WQED-TV in Pittsburgh
"Silent Epidemic: The Liver Disease NASH" was the brainchild of local man and NASH kNOWledge President & Founder, Tony Villiotti, who received a life-saving liver transplant following an arduous journey that started with a simple fatty liver diagnosis that progressed to nonalcoholic steatohepatitis (NASH), cirrhosis and liver cancer. Villiotti teamed up with The Videohouse and award-winning film director Susan Brozek Scott to produce the film, intending to help others prevent a similar fate.
Map of Liver Cells Provides Insights That Could Boost the Search for NASH Drugs
Now a team of scientists led by the University of Michigan has created a detailed map of liver cells, showing how different cells communicate with each other. By comparing healthy and diseased livers, they also identified changes to these cells that could drive the progression of NASH. They hope the map will inspire new targets for drug development.
Going Global - Personal Struggles with Liver Disease led Donna Cryer to Advocacy
Donna Cryer is a liver policy wonk par excellence. She’s not only a Harvard graduate and lawyer but also the founder and CEO of the five-year-old Global Liver Institute, whose aim is to improve the lives of people living with liver disease, which affects up to 30 million Americans.
Impact of Exercise on Physical Frailty in Patients With Chronic Liver Disease
Physical frailty is common in chronic liver disease and the setting of liver transplantation. It is associated with poor quality of life, increased hospitalization, and mortality. Despite this, the impact of exercise in these patients remains poorly understood.
First Investigational Drug Therapy for Liver Disease NASH Awaiting FDA Approval
Patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease and a leading cause for liver transplantation in the U.S., currently lack an approved drug therapy, but this may soon change. A large Phase III clinical trial designed in collaboration with Virginia Commonwealth University is the first to demonstrate the safety and efficacy of an oral medication to treat the disease.
Obeticholic Acid for the Treatment of Non-Alcoholic Steatohepatitis: Interim Analysis from a Multicentre, Randomized, Placebo-Controlled Phase III Trial
Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase III study of obeticholic acid for NASH.
Leveraging Clinical Pharmacology to Optimize Drug Development for NASH & Cholestatic Liver Diseases
To further assist in drug development for NASH and cholestatic liver disease indications, Duke-Margolis and the FDA are convened a public meeting on December 9 to discuss clinical pharmacology driven considerations and promising approaches to optimize drug safety and efficacy. View the video of that meeting.
Patient Perspective
Kim - NASH and transplant patient
Kimberly discovered she had NASH when she lost weight to become a living kidney donor for her older brother, Paul.
"I wish I would have been told that cirrhosis could be caused by things other than drinking or drug abuse. I was clueless, and no one told me [that] being heavy my whole life was most likely the reason I developed cirrhosis. I only found out my diagnosis, NASH, from my discharge papers. I found out what NASH was by looking it up on Google. I definitely would have benefitted from point-of-care patient counseling." (Source: Global Liver Institute)
NASH Council
GLI held a NASH Council virtual meeting on Thursday, November 21 attended by NASH Council members to discuss updates and develop the NASH Council Workgroups - Clinical Practice, Lifestyle/Nutrition, Policy, and Communications (New!). A report on the meeting has been made available for NASH Council members.
For more information on the NASH Council or workgroups, please contact us at nash@globalliver.org.
View the membership list. Want to be a member? Fill out the Membership Application Form.
GLI NASH Partner Highlight
The Liver Forum
The Liver Forum is an initiative of the Forum for Collaborative Research, part of the University of California, Berkeley School of Public Health. The Liver Forum was launched in 2014 in response to The Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (NAFLD) meeting sponsored in 2013 by the U.S. Food and Drug Administration (FDA) and the American Association for the Study of Liver Disease (AASLD).
The Liver Forum aims to advance the regulatory sciences for the treatment of Non-Alcoholic Steatohepatitis and liver fibrosis by providing an independent and neutral venue for ongoing multi-stakeholder dialogue to identify and address gaps in the field. Neutrality and objectivity is ensured through representation and active engagement of scientific experts from all stakeholder groups, including academia, industry, patient community, and regulatory agencies.
GLI President and CEO Donna R. Cryer, JD is included in this expert group of stakeholders on the steering committee as a community representative.
Learn more at The Liver Forum
Global Liver Institute Partner Events
5/1-3/2020 - Cardiometabolic Congress West - Scottsdale, AZ, USA
6/26-28/2020 - Medical University of South Carolina Metabolic Disorders Conference - Kiawah Island, SC, USA
10/21-24/2020 - Cardiometabolic Congress Boston - Boston, MA, USA
Upcoming Events
1/23-25/2020 - ASCO GI Symposium - San Francisco, CA, USA
1/9-11/2020 - NASH-TAG Conference - Park City, UT, USA
1/13-14/2020 - 13th Paris Hepatology Conference - Paris, France
03/13-14/2020 - Swiss Autoimmune Liver Patient conference - Lugano, Switzerland
04/15-19/2020 - EASL 2020, London, UK
5/4-7/2020 - 4th Annual NASH Summit - Boston, MA, USA