Noninvasive Liver Screening Technology Enables Providers to Detect Liver Disease in Asymptomatic Patients, Identify At-Risk Patients for Referral

By Juan Pablo Frias, M.D., Endocrinologist and Principal Investigator, Velocity Clinical Research, Los Angeles

Nonalcoholic fatty liver disease (NAFLD) is an asymptomatic and underdiagnosed disease that affects approximately 37% of U.S. adults and 70% of individuals with type 2 diabetes. An estimated 85.3 million Americans have NAFLD, and 17.3 million have nonalcoholic steatohepatitis (NASH), the more severe form of NAFLD marked by inflammation and hepatocellular damage (“ballooning”), which can lead to hepatic fibrosis, cirrhosis and hepatocellular cancer (HCC) if left untreated. These conditions contribute billions of dollars to the country’s healthcare costs.

Liver disease is frequently asymptomatic, challenging early identification in the primary care setting. For this reason, more healthcare providers are seeking options to help them better identify patients with NAFLD, and particularly those who have progressed to NASH and have hepatic fibrosis, so that they can improve referrals to a specialist and care management. 

NAFLD commonly occurs in people with obesity and type 2 diabetes. Importantly, NASH is more prevalent in certain populations, and in persons with overweight/obesity, type 2 diabetes, and/or multiple cardiometabolic risk factors such as hypertension and dyslipidemia. Hispanic populations, for example, have a high prevalence of fatty liver disease compared to non-Hispanic groups. 

Effective Referral Process

It’s important for primary care healthcare providers and other non-specialists/non-hepatologists to look for NAFLD and properly stage it so that a standard process for making referrals to specialty care can be followed. In a patient with NAFLD/NASH, the most important predictor of poor outcomes (cardiovascular and liver-related) is the presence of advanced hepatic fibrosis.

NAFLD is a diagnosis of exclusion. Therefore, one must exclude alcohol liver disease (ALD), which may be determined based on the patient’s degree of alcohol consumption. Fatty liver disease can also be caused by certain medications and rare genetic disorders. As mentioned above, an estimate of liver fibrosis, should it exist, is important to know for patient prognosis, referrals, treatment and follow-up.

Typically, when type 2 diabetes co-exists with NAFLD, it worsens the patient’s metabolic profile and increases the risk for cardiovascular disease. The combination of these two conditions makes NAFLD more difficult to treat, and NAFLD has a prevalence of 70% among type 2 diabetes patients versus a prevalence of approximately 57% among the general population in the US.

High-risk populations, including patients with type 2 diabetes, should be screened for NAFLD and fibrosis. This can be done with non-invasive tests, including FIB-4, a blood test that uses common parameters to determine risk of advanced fibrosis, and technologies such as FibroScan, a non-invasive tool that uses liver stiffness measurement (LSM) by vibration-controlled transient elastography(VCTE),controlled attenuation parameter(CAP) andspleen stiffness measurement(SSM by VCTE) to provide a powerful level of support at the point of care. This rapid, office-based, non-invasive technology can quickly identify asymptomatic individuals and help determine if they have NAFLD and fibrosis.

High-risk patients, including those with obesity, diabetes and high cholesterol, can be examined easily to gain fast results that can be used to stage a patient and determine who can be followed in the primary care clinic or referred to a hepatologist.

One study using this FibroScan technology found 70% of a high-risk population had significant hepatic steatosis (fatty liver), 20% had abnormal liver stiffness (fibrosis), and 15% had clinically significant liver stiffness. Among this group, 90% of those who underwent a liver biopsy had a positive correlation between the FibroScan LSM result and the liver biopsy reading. Liver fibrosis is the strongest predictor of important outcomes, including hepatic decompensation, liver cancer and overall mortality.

Clinical Practice Guidelines 

LSM by VCTE combines standardization, clinical performance and accessibility for early patient identification, first in line after FIB-4, either in primary care, diabetology clinics or liver clinics. Using non-invasive tests helps to determine the most appropriate care pathway for asymptomatic NAFLD, which is important because timing of treatment relies on accurate staging and a consistent, timely and evidence-based management approach.

The American Association of Clinical Endocrinology (AACE) recently issued a clinical practice guideline for the diagnosis and management of NAFLD in primary care and endocrinology clinical settings, stating that to stage the risk of fibrosis in people with NAFLD, clinicians should choose VCTE as the best validated to identify advanced disease and predict liver-related outcomes. 

Guidelines from the European Association for the Study of the Liver (EASL) also recommend LSM by VCTE screening for at-risk populations, such as patients with NAFLD. All recommended cut-off values are clearly specified for LSM by VCTE. 

For primary care physicians who want to improve diagnosis and prognosis for patients with NAFLD—and for following patients over time, during and post-treatment—LSM by VCTE is an essential tool.