August 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.
We would appreciate your feedback and content contributions. Please contact nash@globalliver.org
GLI Perspective
Although summer is normally a time for vacationing, the GLI NASH Council has been actively working on policy and clinical workflow issues that will impact NASH for years to come. In July, GLI CEO Donna R. Cryer, JD and VCU Professor Arun J. Sanyal M.D. submitted a letter of request for modifications of the ICD-10 CM codes in distinguishing between early and advanced stages of fibrosis of NASH. The purpose of this request is to bring greater clarity and usefulness to the medical coding around NASH, as currently there is limited ability to specify the severity of fibrosis in the existing code. These changes would enable more nuanced tracking of patients, and facilitate claims-based research on disease progression and potential impact of interventions on various stages of the disease. Adding to this, these revisions would allow for clearer identification of patients at all stages of the disease, particularly those who are at greater risk for liver-related mortality and other hepatic complications, and align with the capabilities of non-invasive diagnostic and staging tests. GLI’s next steps include supporting Dr. Sanyal’s presentation of the clinical aspects of NALFD/NASH to CMS in the September ICD-10 CM proposal.
GLI Updates
AJMC Podcast
The Global Liver Institute CEO Donna Cryer, JD was a featured guest on an American Journal of Managed Care’s (AJMC) recent podcast. The podcast involved in depth discussions regarding the increased prevalence of NAFLD and NASH in the United States, as well as the lack of current approved treatments on the market. Listen to the full podcast here.
GLI Advocacy Facebook Group
GLI recently launched its Liver Health Advocates Facebook group! This platform is being used as an online space for you and your peers to discuss your advocacy needs, share your experiences, and connect with each other. We encourage you to invite your fellow liver patients, support networks, and others who help advocate for liver health! Email a3@globalliver.org for an invitation.
NASH Council
Our June 1st 2018 NASH Council meeting report is now available through the members’ portal.
Members have the benefit of accessing the secure NASH Council portal and participating in our all member council meeting. View our membership list.
Want to become a member? Complete the Membership Application Form.
NEW MEMBER: American College of Physicians
The American College of Physicians (ACP) is the largest medical speciality organization in the world, consisting of over 154,000 members globally. Their members are primarily physicians and internists specializing in the prevention, detection, and treatment of illnesses in adults. The ACP provides information, advocacy and education for their members as they practice internal medicine and related specialities such as cardiology and hepatology.
Patient Opportunity: coreNASH
Interested in making a difference in the future of NASH treatments? Consider participating in coreNASH, a project run by the Center for Medical Technology Policy (CMTP). The goal of coreNASH is to define a core set of outcomes for drug developers to incorporate in their development programs so their assessments can sufficiently measure, differentiate, and demonstrate the value of new therapies relative to the existing standard of care for NASH patients. The project employs a structured Delphi consensus process and includes two online surveys and one in-person meeting. Each patient who participates will be provided $600, find out more here.
NASH Facts
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), between 30-40% of adults in the United States have NAFLD, although they might not know it.
- It’s estimated that about 20% of people with NAFLD have NASH.
- Children are also affected, research suggests that close to 10% of US children ages 2-19 have NAFLD.
Industry
Breathtec Biomedical Inc.
On August 2nd, a Vancouver company, Breathtec Biomedical Inc., announced the opening of a new drug development branch and signed a letter of intent to acquire all of Nash Pharmaceuticals Inc. shares. Nash Pharmaceuticals is a drug development company that repurposes drugs with a research focus on NASH, chronic kidney disease, and inflammatory bowel disease. Currently, Nash Pharmaceuticals researchers have identified up to two potential compounds for the treatment NAFLD & NASH in their ongoing research projects.
Conatus Pharmaceuticals
Conatus Pharmaceuticals, a biotechnology company that focuses on liver disease research and drug development is working with Novartis. Conatus is currently in phase 2b of clinical trials for ENCORE (EmricasaN, a Caspase inhibitOR, for Evaluation). These trials aim to evaluate the effects of the drug Emricasan on patients with fibrosis or cirrhosis caused by NASH. EmricasaN modulates functions affecting cell death and inflammation. The trials for ENCORE are broken up into ENCORE-PH to test patients with portal hypertension, ENCORE-NF to test patients with NASH fibrosis, and ENCORE-LF to test the liver function in patients with NASH cirrhosis. The Conatus website includes detailed background information on liver disease.
Regulatory
Food and Drug Administration (FDA)
On July 31, 2018, Shionogi Inc received approval from the FDA for the drug lusutrombopag (Mulpleta) to treat thrombocytopenia in adults with chronic liver disease who are about to undergo a medical procedure. Thrombocytopenia is frequently seen in patients with chronic liver disease, including NAFLD & NASH. It is characterized by low blood platelets due to reduced production of thrombopoietin. The FDA gave approval based on two randomized, double blind, placebo controlled trials involving 312 chronic liver disease patients with severe thrombocytopenia. The ability to treat thrombocytopenia in liver disease patients could lead to reduced risks of complications for “diagnostic procedures and patient care, such as liver biopsies or clinical trials for cirrhotic patients.” Full press release from Shionogi Inc. can be found here.
Research & Studies
Center for Disease Control and Prevention
The results from a Center for Disease Control (CDC) study conducted between 1999-2016 on liver disease related mortality rates in the US have been released. A major finding of the study was that NASH, alcohol-induced cirrhosis, and hepatocellular carcinoma rates have all drastically increased, contributing to the evidence that preventable liver disease is a growing problem. Donna Cryer, CEO and President of GLI, commented on the findings of the study here: Liver Cancer Has Risen to the Sixth Deadliest Cancer in the U.S.
Pfizer
Do Unhealthy Shift Work Hours Contribute to NASH?
In one of its recent publications regarding NASH, Pfizer includes a helpful list of risk factors for NASH. One of those risks is shift work. The National Sleep Foundation defines shift work as “work that takes place on a schedule outside the traditional 9 am – 5 pm day. It can involve evening or night shifts, early morning shifts, and rotating shifts.”
Shift work is not a new phenomenon, however, it has a growing interest from public health personnel. Specifically, “night workers and shift workers were recently shown to be at greater risks of obesity, metabolic syndrome, and fatty liver disease.” Inadequate and disrupted sleep durations caused by shift work schedules often induce inappropriate dietary habits (unusual eating schedules) and overeating among shift workers. When one routinely sleeps an insufficient amount of hours (<7 hours a night for adults) the appetite-stimulating hormone Ghrelin rises in the body, causing the person to crave and eat more food, including energy-dense foods.
Over-ingesting simple carbohydrates, lipids and saturated fatty acids, and cholesterol (all traditionally found in energy-dense foods) is closely associated with the onset of obesity, and in turn the development of Nonalcoholic Fatty Liver Disease (NAFLD). Additionally, deficient intakes of vitamins D and E are often observed in many NAFLD and NASH patients. Vitamin D reduces inflammation and assists autoimmunity and vitamin E relieves oxidative stress and increases liver health. Deficiencies of both of these micronutrients contribute to the progression of NAFLD and NASH in the body and these collaterally persist with poor dietary habits. From these findings, nutritional therapy is advised to NAFLD patients.
In the United States, our 24/7 economy encourages shortened and disrupted sleep schedules (via shift work), which in turn promotes malnutrition among other unhealthy dietary habits, which may adversely lead to the further development of NASH (or NAFLD).
For Your Calendar
September 21-22: GLI’s Advanced Advocacy Academy
October 22-24: 2nd NASH Summit. Frankfurt, Germany
November 9-13: The Liver Meeting 2018. San Francisco, CA.
