Clinical Care Pathway Released for NAFLD, NASH

A new clinical care pathway is available for clinicians managing patients with nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH).

That includes primary care, endocrine, obesity medicine, and gastroenterology practices, according to the American Gastroenterological Association (AGA). The AGA worked with other professional societies, including the American Diabetes Association, American Osteopathic Association, Endocrine Society, and the Obesity Society, to develop an NAFLD/NASH Clinical Care Pathway that the groups say will facilitate “value-based, efficient, and safe care that is consistent with evidence-based guidelines, and setting the stage for future studies to examine the outcomes of such pathways.”

NAFLD is a largely asymptomatic, silent disease and the incidence is rising. About 37% of US adults and as many as 70% of individuals with type 2 diabetes (T2D) have NAFLD. NASH is a subtype of NAFLD and is marked by inflammation, ballooning, and Mallory’s hyaline on liver biopsy; it can lead to hepatic fibrosis, cirrhosis, and hepatocellular cancer (HCC).

The pathway outlines a 4-step screening process for NAFLD/NASH:

• Identifying patients with clinically significant hepatic fibrosis (fibrosis stage 2 or higher) in order to prevent disease progression, including those with T2D, patients with 2 or more metabolic risk factors, and those with incidental findings of hepatic steatosis or elevated aminotransferases.
• Screening all at-risk patients for alcohol use and provide liver function tests (or comprehensive metabolic panel) and a complete blood count as part of the initial screening process.
• Conduct non-invasive testing in at-risk patients for clinically significant liver fibrosis using simple, nonproprietary fibrosis scores.
• Referrals to specialists for patients with discordant or indeterminate Liver Stiffness Measurement (LSM) results (8.0 to 12.0 kPa) for further diagnostic evaluations, such as a liver biopsy or magnetic resonance elastography (MRE).

Care should be managed by a multidisciplinary team, due to the complexity of care created by obesity, diabetes, cardiovascular disease (CVD), and NALFD with fibrosis. Early interventions aim to prevent the development of cirrhosis and liver-related and all-cause mortality in an environment of shared decision-making.

In addition, providers must also try to help patients reverse metabolic trends in CVD, which is the main cause of morbidity and mortality before cirrhosis sets in.

The pathway lays out what is needed for both low-risk and high-risk patients.

Patients at low risk of advanced fibrosis should be managed using therapeutic lifestyle interventions, such as weight loss, nutritional strategies, stress management, regular physical exercise, and avoiding excess alcohol intake. Specific drug treatment targeting liver steatosis is not necessary in a low-risk population, according to the pathway.

Patients at high-risk advanced fibrosis should be managed by a multidisciplinary team closely coordinated by a hepatologist who can monitor for cirrhosis, hepatocellular carcinoma, and other cirrhosis-related complications. Lifestyle changes aimed at long-term weight loss should be more aggressive at this stage, including a greater use of formal weight loss programs and possibly surgery.

Patients with an indeterminate risk of advanced disease should be managed using a similar approach to high-risk patients, along with additional diagnostics to confirm the stage of hepatic fibrosis. In some cases, proprietary plasma biomarker tests for fibrosis staging or additional imaging-based fibrosis measurement studies may be used.