March 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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LIVER BIOPSY: “Proceed with Caution!”
On its website, the Agency for Healthcare Research and Quality (USDHHS) has published a case study titled “Liver Biopsy: Proceed with Caution” prepared by Don C. Rocky, MD, Professor and Chairman, Department of Medicine, Medical University of South Carolina in Charleston, SC.
The case describes a 42 year old woman with a history of multiple cancer malignancies who arrived at an emergency room in an acute condition. Following an abdominal ultrasound, she was admitted and a liver biopsy was performed. The report describes her condition and the failure of the hospital staff to recognize her post-biopsy internal hemorrhaging from which she died a few hours later.
Dr. Rocky has provided an important service by documenting the case and also reviewing uses of liver biopsy, its contraindications, potential complications, and the need for post-biopsy monitoring. The article includes three useful summary tables: contraindications to liver biopsy, complications of liver biopsy, and factors important in determining the risk of complications of liver biopsy.
For GLI’s perspective on liver biopsy, “Beyond the Biopsy,” see the December 2018 issue of NASH News.
Second International NASH Day | June 12, 2019
International NASH Day is a call to action campaign launched by the NASH Education Program in June 2018 to raise awareness and promote early intervention to treat fatty liver disease and its more advanced form, nonalcoholic steatohepatitis (NASH), which affect more than 115 million people globally. This year, GLI is honored to spearhead International NASH Day and collaborative efforts with the American Liver Foundation, EASL-International Liver Foundation & European Liver Patients Association. This unified initiative will elevate the voice of the patients, promote innovation and improve the impact of the liver community through social media, congressional briefings, clinical trials and screenings.
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A Real World Health Care interview with Donna Cryer
“We want to change the culture around liver disease to reduce stigma, change policies so patients have better access to care, and change healthcare delivery systems and reimbursement frameworks so new treatments get to the patients who need them.” -Donna Cryer
“Where Does NASH Stand on the Global Public Health Agenda?”
Last month, Donna Cryer was interviewed by Real World Health Care as part of an ongoing series about NASH. Cryer reports that GLI is “working with physicians in hepatology, diabetes, cardiovascular and primary care to delineate how and by whom patients with NASH and other fatty liver diseases can be diagnosed earlier and referred to the appropriate specialist in a timely manner.” She urges greater priority for liver health on the global health agenda and focuses on the need for noninvasive screening and imaging technologies. See the July issue for the full interview.
NASH Guidelines & Quality Measures
GLI has researched and created a chart comparing NAFLD and NASH definitions and guidelines published by six organizations: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Association for the Study of Liver Diseases (AASLD) and American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), European Association for the Study of the Liver (EASL), and World Gastroenterological Organization (WGO). For each organization listed in the chart, GLI recorded their guidelines for five factors: 1. definition of NASH; 2. risk factors; 3. threshold for screening; 4. recommendations for screening; and 5. recommendations for management. Source references are included at the end of the chart.
Call to Action: Kiss & Click Challenge
Amsety and the Fatty Liver Foundation have joined forces to raise awareness on liver disease and encourage donations for those who are unable to afford fatty liver disease screenings and examinations. If you are interested in participating, determine your Liver Health Score at www.amsety.com/liver-healthy-score , post a video on social media with the hashtags #kissandclick and #livermatter and tag three friends to join the challenge.
GLI NASH Council Announcements
New NASH Program Director: Yolanda Gule
Thank you for the warm welcomes during my first weeks at GLI. I have had the chance to learn more about our plans for 2019, and I want to keep the momentum going! Hearing your ideas and suggestions is valuable to me as I work to accelerate our focus on NAFLD and NASH. So, let’s keep talking!
In addition to group calls, I’m setting aside time to speak with each NASH Council member. I will be reaching out soon to connect, but if you would like to contact me, please feel free to email me at firstname.lastname@example.org.
New Member Spotlight
Apollo Endosurgery, Inc. is a medical device company focused on less invasive surgical therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal conditions. Apollo’s device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 70 countries today and include the OverStitch™ Endoscopic Suturing System and the ORBERA® Intragastric Balloon.
Lifestyle Intervention Workgroup
Clinical Workflow Workgroup
More details coming soon!
May/June in Washington, DC
November in Boston, MA (consecutive with AASLD meetings)
More details coming soon!
NASH Council Members in the News
Research & Treatments are Moving Toward Conclusion - Intercept Pharmaceuticals
On Feb. 19, Intercept Pharmaceuticals announced positive results for its obeticholic acid (OCA) treatment for NASH. The Phase 3 trial enrolled 931 patients with liver fibrosis who were randomly assigned to a daily placebo or OCA at one-to-two doses. After 18 months, the study concluded that higher OCA doses showed a reduction in liver fat and inflammation. The company plans to submit its application for approval of the treatment, obeticholic acid (OCA), to the Food and Drug Administration (FDA) during the second half of 2019. For a review article, click here.
NASH Research & Development
HepQuant SHUNT Liver Diagnostic Test - | HepQuant, LLC
The HepQuant SHUNT Liver Diagnostic Kit is used for assessment of liver function through the quantitative detection of 13C-cholate and d4-cholate in blood serum, collected after the intravenous administration of 13C-cholate and the oral ingestion of d4-cholate. It is being studied as an aid in the determination of the likelihood of large esophageal varices in patients with chronic liver disease (CLD). The SHUNT-V clinical trial will enroll 420 subjects at up to 20 U.S. research sites.
Dr. Ron Newfield encourages, “clinicians to take a closer look a diabetic patients with abnormal liver enzymes.”
Dr. Ron S. Newfield, MD, a pediatric endocrinologist at the University of California, San Diego and Rady Children’s Hospital, motivates clinicians to take a closer look at diabetic patients with abnormal liver enzymes.
A study published in Pediatric Diabetes analyzed data from 38 children who had been diagnosed with type 2 diabetes mellitus. The study’s goal was to determine the histologic characteristics in children with type 2 diabetes, and to determine what factors contribute to the development of NASH inlcuding phenotypes, ethnicity, lipid profiles and diabetes management and control.
Pioglitazone or Vitamin E for NASH Study (PIVENS)
Researchers found that a daily dose of the natural form of vitamin E—the type of vitamin E that comes from food sources and is not synthetic (laboratory-made)—improved NASH in study participants overall. Pioglitazone also improved some features of NASH, although researchers couldn’t prove that the improvements did not occur randomly. Many study participants taking pioglitazone gained weight, and many participants did not improve from either treatment. More research is needed to determine whether treatment with vitamin E or Pioglitizone causes long-term risks.
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC) Trial
The TONIC trial found that the natural form of vitamin E—the type of vitamin E that comes from food sources and is not synthetic (laboratory-made)—improved the most severe form of fatty liver disease in some children. More research is needed to determine whether treatment with vitamin E causes long-term risks.
NASH (Lifestyle Intervention) - articles on nutrition, exercise and sleep
Try the “Balanced Plate Method”
Try to incorporate the following tips in your healthy lifestyle
Drink more water, avoid alcohol
Keep a food journal and track all meals
Practice portion control and mindful eating
Combat stress through a faith practice, meditation, counseling and/or activity
Swap-out processed and calorie-dense foods for raw and nutrient-dense foods
Get a minimum of 7-8 hours of sleep each night and try to maintain the same bedtime throughout the week
Be consistent! Do your best to incorporate these tips into your healthy lifestyle. Over time, your body will adapt to these changes and this new lifestyle will become easier to follow
Try balancing your plate using Glass Meal Prep Containers