Non-alcoholic fatty liver disease (NAFLD), an umbrella term for a range of liver conditions affecting people who drink little to no alcohol, affects approximately 100 million individuals in the United States. Its more serious form is called non-alcoholic steatohepatitis (NASH). NAFLD affects approximately 25% of the worldwide population and as many as 6% are affected by NASH, with NASH prevalence expected to increase by 63% by 2030.
For this reason, a new study validating the cost-effectiveness and efficiency of innovative tools designed to identify people at risk for active fibrotic NASH is good news for patients and physicians alike. NASH is an asymptomatic, progressive and burgeoning liver disease that can lead to increased liver-related mortality and morbidity.
The Rise in Liver Disease
The rise in adult obesity rates in the United States and worldwide has led to more people experiencing liver damage and associated health issues. In fact, obesity rates are increasing across America, with rates ranging from 25 to 38% of the adult population.
There is a growing awareness of the devastating impact of obesity on vital organs, especially on the liver. Obesity can cause insulin resistance, resulting in a buildup of blood sugar and an increase in the amount of free fatty acids circulating in the blood and inside the liver cells.
Also, a buildup of fat in the liver is common in those with Type 2 diabetes, increasing the risk of liver fibrosis, cirrhosis or ultimately liver cancer. Furthermore, NAFLD has been found to be a strong and independent risk factor for pre-diabetes in the general adult population.
The good news is that most liver disease is avoidable, and health care providers have new tools that provide rapid, painless and consistent results that enable them to make the most informed treatment decisions, while also ruling out the need for an expensive liver needle biopsy or another invasive test.
Study Gives Hope for Treating Liver Disease
Published in The Lancet Gastroenterology & Hepatology, a recent study, “FibroScan-AST (FAST) Score For The Non-Invasive Identification Of Patients With Non-Alcoholic Steatohepatitis With Significant Activity And Fibrosis: A Prospective Derivation And Global Validation Study,” demonstrates that FAST — which is available on the myFibroScan app—helps clinicians cost-effectively identify individuals.
The FAST Score is a combination of three components — two physical biomarkers: liver stiffness by VCTE™ and CAP™, estimating fibrosis and steatosis from an examination with FibroScan, plus AST, a readily available blood marker of inflammation.
Based on this prospective study including 1,400 patients undergoing a liver biopsy, this publication demonstrates the value of FAST as a tool to enhance the diagnostic capabilities of healthcare providers to efficiently identify patients with a high probability of active fibrotic NASH. With these study results, FAST emerges as a vital tool for cost effectively and efficiently identifying the 12.2 million people in the United States and European Union who may be living with active, asymptomatic fibrotic-NASH.
The study is timely and significant because the efficient identification of active fibrotic NASH has long been a challenge for drug companies, with many now developing drugs that target this health crisis.
In clinical trials to develop NASH drugs, over 50% of patients fail to meet the inclusion criteria, with the majority not having active fibrotic-NASH. As treatments become available for active fibrotic NASH, FibroScan, and tools like FAST support diagnosis efficiency at the point of care, improving diagnostic accuracy and reducing costs.
FAST is inexpensive, reducing unnecessary, invasive assessments and the need for expensive, complex blood tests. It’s simple to determine and interpret – requiring just three numbers entered into a calculator on the myFibroScan app. Furthermore, the clinician can set the threshold for referral based on their goals, balancing sensitivity vs. specificity. The FibroScan examination is a simple, noninvasive test that provides biomarkers that can be used to diagnose and monitor liver health, providing immediate results for the treating clinician.
FAST represents a significant advancement for FibroScan-based models of care and the first of many scores where the FibroScan physical biomarkers could potentially be combined with circulating biomarkers to enhance assessment and monitoring of liver health.
Scott Howell DO, MPH&T, CPE, is an Advisor with Echosens.