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The Academy of Managed Care Pharmacy (AMCP) Nexus 2019

NASH Has Gone Under the Radar, but It Is the "Elephant in the Room," Panelists Say

Laura Joszt
Although the number of people with nonalcoholic fatty liver disease, which progresses to nonalcoholic steatohepatitis (NASH), is growing, the health system is still trying to get a handle on which patients to target and how to identify them before the first treatments come to market, explained panelists during a session at AMCP Nexus 2019.
Although the number of people with nonalcoholic fatty liver disease (NAFLD) is growing, the health system is still trying to get a handle on which patients to target before the first treatments come to market, explained panelists during a session at AMCP Nexus 2019.

Wing-Kin Syn, MD, PhD, attending physician, Medical University of South Carolina, started the session with a discussion of clinical progression and how to identify patients for treatment. NAFLD is a result of accumulation of fat in the liver, and it is commonly associated with risk factors like obesity, type 2 diabetes, hypertension, and hyperlipidemia. Some of the less known risk factors are obstructive sleep apnea, polycystic ovary syndrome, gout, and hypothyroidism, explained Syn.

NAFLD states as simple fat, which impacts and 20% to 30% of those individuals who progress to nonalcoholic steatohepatitis (NASH). Another 20% to 30% of individuals progress to more advanced NASH fibrosis, and the final stage is NASH cirrhosis. It used to be thought that progression from early stage NAFLD to cirrhosis took decades, but recent studies have shown that some people progress rapidly within 2 years. However, research has also shown that there is reversibility.

“The question, then, is who are the individuals who regress?” Syn asked. “Well, that remains a challenge to identify.” It is also unclear how to identify those people who have slow progression versus rapid progression.

Not all fatty liver disease is the same, Syn added. Patients with a lot of scar damage are at the most risk of liver death. Patients can be stratified by stages of fibrosis (0-4) and those in stages 2-4 have additional complications and are most likely to succumb to liver death. Patients who have NASH fibrosis also have lower patient-reported outcomes with worse physical health, more fatigue, and less vitality.

It’s important to pay attention to NAFLD because of the cost of the disease and the real public health impact it is having. About 2% to 3% of the US population has NASH cirrhosis, which compares with 8% for type 2 diabetes, 2% for hepatitis C virus (HCV) infection, 0.5% for HCV cirrhosis, and 0.3% for colorectal cancer.

“The elephant in the room really is this condition,” Syn said. He added that the annual direct medical costs are estimated to be more than $100 billion.

An important area will be figuring out which patients to target. Right now, liver biopsy is the gold standard, but it is expensive and painful with bleeding. Other tests being used include liver function tests, which are neither predictive nor indicative of NASH or fibrosis; ultrasound, which is the cheapest and quickest to do; and cross-sectional imaging, which isn’t routinely done and only can distinguish very extreme cirrhosis.

There are some noninvasive tests available that are not widely used, such as vibration-controlled transient elastography, which measures liver fat, and magnetic resonance elastography. However, a lot of the modalities are still under research.

“It is clinically important to identify those with significant or advanced fibrosis,” but at this time it’s difficult to identify those patients at risk, Syn said.



 
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