A Worldwide Effort to Defeat Nonalcoholic Steatohepatitis (NASH)
• The silent disease known as NASH is on the rise worldwide. Therefore, stronger public awareness is needed in detecting NASH and fibrosis early in order to facilitate timely and quality medical intervention.
• With the liver biopsy as the current gold standard for NASH diagnosis, HistoIndex can greatly facilitate the development of precise and effective therapeutics for a huge unmet need for NASH diagnosis and treatment.
• As part of the international NASH Education Program™, HistoIndex has joined over 150 world experts in a global call of action to promote the awareness of NASH in Singapore. In addition, HistoIndex is the first local benefactor of the 1st International NASH Day event, set to take place on 12 June 2018.
SINGAPORE, 8 JUNE 2018 – Functioning as one of the vital organs in our body, the liver is prone to many insults such as Hepatitis B, C and frequent alcohol intake. More recently, the liver has fallen victim to adverse conditions caused by unhealthy diet and sedentary lifestyle habits, a condition known as Nonalcoholic Fatty Liver Disease (NAFLD).
Amongst those with NAFLD, the most aggressive form is Nonalcoholic Steatohepatitis (NASH) – a condition where there is continuous fatty injury to the liver among those who consume little or no liquor. NASH is now a global burden that affects all populations facing a rise in diabetes and obesity, and Singapore is not spared from this pandemic as well. According to a 2016 study by doctors from the Singapore General Hospital, NAFLD was found to be on the rise in Singapore, and could well be affecting half of the adult population1.Video Credits: NASH Education Program™
Threat to Liver Health in Singapore
In 2015, the International Diabetes Foundation reported that Singapore has the second highest proportion of diabetics among developed nations2. The results reflected the reality of the general lifestyle of Singaporeans, involving less physical activity and more high-calorie diets, both of which increase the risk of obesity and diabetes. These are in fact well-known risk factors for the development and progression of NAFLD.
Says Prof Dan Yock Young, Senior Consultant from the Division of Gastroenterology & Hepatology at the National University Hospital (NUH), “Unfortunately, NASH is a silent disease with no symptoms or signs until the liver is significantly damaged by scarring – a condition known as cirrhosis – and starts to fail. Most patients diagnosed with NAFLD or NASH today are usually discovered when they have had a health screening or related blood test done for another medical condition. Typically, an abnormal liver function test or fatty liver on an ultrasound procedure would highlight the first clue that the liver is not doing well.”
While multiple non-invasive strategies are being tested and evaluated as potential population screening tools, Prof Dan highlights the liver biopsy as the definitive gold standard diagnosis today after excluding other causes, “Although an invasive procedure with minor risk of complications such as bleeding, the liver biopsy is performed for patients who are at risk and whose liver cannot be definitively assessed by non-invasive means. This will determine the amount of fat in the liver, the degree of inflammation and the extent of fibrotic scarring, therefore allowing us to clinch the diagnosis, assess the severity and prognosticate the fatty liver.”
“NUH has witnessed the same worrying sign worldwide – an exponential rise in NAFLD contributing to liver cirrhosis, transplant and liver cancer in the last three decades. As such, together with other hospitals, we are focusing our research and attention on improving diagnostics, care and management for patients with NASH”, added Prof Dan.
The Need for Early Intervention
If NASH is detected early, it can be reversed as the inflamed liver would not have developed any thick scarring. If detected late, the liver will progress to an advanced stage of fibrosis, where the liver cells would have been replaced by scar tissue, making the organ dysfunctional. This advanced stage of fibrosis also increases the risk of hepatocellular carcinoma (liver cancer). A patient at this stage faces a poor outcome due to limited therapeutic options.
Although there are no approved drugs today, there are currently more than 50 US Food and Drug Administration (FDA) Phase 2 and 3 clinical trials to find a treatment for NASH3. Therefore, stronger public awareness is needed in detecting NASH and fibrosis early – incorporating both screening and biopsy – that will facilitate timely and quality medical intervention. And innovative medical technologies have entered the healthcare scene with the promise to enhance liver diagnosis.
Prof Dan explains “Current interventive trials are anchored on determining the efficacy of therapy to improve steatosis, inflammation and fibrosis using a consensus scoring formula, administered by expert liver pathologists. As understanding of NAFLD evolves, the scientific community is learning more about the pathogenesis of disease and how complications develop. New technologies such as advanced imaging, high throughput scanning and novel molecular markers are also being incorporated to better ascertain and objectively quantify the severity of different aspects of the disease. This is of tremendous importance in the current phase of drug development to understand the extent of what each therapeutic strategy can achieve.”
In addition, Dr Gideon Ho, CEO of HistoIndex, explains, “Liver biopsy remains as the gold standard of NASH diagnostics as well as drug development. To help address the unmet needs of both diagnosis and treatment would mean having an advanced and integrated tissue diagnostics tool that can help in accurately tracking responses to treatment during clinical trials. Therefore, we are looking at a comprehensive management of NASH for patients, ensuring that they have the best opportunity for a positive health outcome.”
This is echoed by the NASH Education Program™, a global awareness initiative that has built a coalition of key stakeholders in the world to launch the 1st International NASH Day on June 12, 2018. The inaugural event features informative and educational on-site activities in more than 20 cities/countries at the same time, as well as a massive online activity, with a content-rich programme developed in six languages.
Mr Jean-François Mouney, President of the NASH Education Program™, commented, “There is a clear threat on individuals as well as on the healthcare system in Singapore, just like in many countries across the globe. If media can help to increase the level of awareness within the Singaporean population at risk of developing severe complications of NASH, it would certainly be a real benefit for the whole country. It would save costs and most importantly lives!”
HistoIndex aims to be a facilitator that bridges innovative digital pathology systems with clinical care, research, and drug development for hospitals, universities and pharmaceutical companies in Singapore and around the globe. With this mission, HistoIndex has stepped on board as the first local benefactor of the inaugural International NASH Day event. The company has also joined over 150 world experts in a global call of action – led by the NASH Education Program™ – to promote the awareness of NASH in Singapore.
1. What is the NASH Education Program™?
The NASH Education Program™ is an awareness initiative that seeks to address unmet needs on a global scale to the following audience, and highlight the importance of early diagnosis and appropriate treatment options specific for NASH:
i) Physicians from all relevant medical specialties who have a key role to play in the clinical management of NASH patients;
ii) Patients and individuals at risk of developing the disease, as they are in need of understanding the causes, mechanisms and consequences of the disease to better manage its progression.
2. Who is involved in the NASH Education Program™?
Key partners include non-profit organisations such as patient advocacy groups (e.g. American Liver Foundation, Global Liver Institute, Fatty Liver Foundation, British Liver Trust, etc.) and learned societies (e.g. ALEH in Latin American, AEEH in Europe). It also involves most prominent KOLs in the space and world experts in NASH, with an ideal footprint in both hepatic and metabolic diseases. Last, it gathers a large coalition of industrial players developing therapeutic and diagnostic solutions.
3. Additional Information
On this 1st International NASH Day, Prof Dan Yock Young will join his peers worldwide in a global “call-to-action”, aimed at promoting disease awareness. “NASH a silent disease, but it is also a severe condition that can lead to clinical outcomes such as cirrhosis, cancer or cardiovascular event.As it increases in prevalence, it is important that the public is aware of this major healthcare threat.”
4. Additional Quote - Prof Stephen Harrison
*As a renowned hepatologist, Prof Harrison is currently involved in working with pharmaceutical companies and their clinical trials for the development of NASH treatments.
“The ability to accurately assess liver disease severity in a timely and efficient manner is critically important to the NASH drug development field. This will allow for efficient diagnosis of patients as well as proper staging of disease by local clinicians, thereby reducing unnecessary screening of many patients that do not meet enrolment criteria.”
Prof Stephen Harrison, Medical Director, Pinnacle Clinical Research, and one of four international liver and metabolic diseases experts from the Scientific Committee of the NASH Education Program™.