Noninvasive Tests May Enable Some Patients With NAFLD Avoid Biopsy

NEW YORK (Reuters Health) – In patients in with non-alcoholic fatty liver disease (NAFLD), noninvasive test result cutoffs may help clinicians diagnose cirrhosis without liver biopsy, a new sudy suggests.

“Patients referred to secondary care often need to have a liver biopsy to assess their disease severity. Because of this study, fewer patients may be referred for liver biopsy in secondary care,” said Dr. Michael Pavlides of the University of Oxford in the U.K.

“Our study confirms that simple noninvasive tests like Fibrosis-4 Index (FIB-4) and liver stiffness measurement by vibration-controlled transient elastography (LSM-VCTE) can be used to screen patients with NAFLD and identify those with low-risk disease who can be managed in primary care,” he told Reuters Health by email. “We also propose noninvasive test upper cutoffs to rule in cirrhosis combined with lower cutoffs to rule out advanced fibrosis.”

As reported in Gut, Dr. Pavlides and his research team conducted an individual-patient-data meta-analysis of studies evaluating noninvasive tests versus liver histology, as part of the imaging study in the multicenter LITMUS (Liver Investigation: Testing Marker Utility in Steatohepatitis) study to evaluate NAFLD biomarkers.

The researchers investigated the individual ability of LSM-VCTE, FIB-4, and NAFLD Fibrosis Score (NFS) to be used as screening biomarkers to rule out advanced fibrosis in 37 primary studies involving 5,735 patients. The median age was 54 years and their BMI, 30 kg/m2; 33% had type 2 diabetes, and 30% had advanced fibrosis.

Area under the receiver operating curve (AUROCs) of individual LSM-VCTE, FIB-4, and NFS for advanced fibrosis were 0.85, 0.76 and 0.73, respectively. Sequential combination of FIB-4 cutoffs (<1.3; 2.67 or greater) followed by LSM-VCTE cutoffs (<8.0; 10.0 or above kPa) to rule in or rule out advanced fibrosis had 66% sensitivity and 86% specificity, and 33% of patients required biopsy to establish diagnosis.

FIB-4 cutoffs (<1.3; 3.48 or greater) followed by LSM cutoffs (<8.0; 20.0 or above kPa) to rule out advanced fibrosis or rule in cirrhosis had 38% sensitivity and 90% specificity, and 19% of patients needed biopsy.

“Non-invasive tests have been studied a lot as screening tests applied at the interface of primary and secondary care,” Dr. Pavlides noted. “It was important to conduct this study and develop algorithms that could help doctors in secondary care evaluate the severity of NAFLD without the need for liver biopsy.”

“NAFLD is one of the leading causes of liver disease, with up to 30% of the global population affected. About every 5 people out of 100 with NAFLD will have advanced liver disease or cirrhosis,” explained Dr. Sonali Paul, an assistant professor of medicine at the University of Chicago Medicine Center for Liver Diseases. “Liver biopsy currenly remains the gold standard for cirrhosis diagnosis, but it is invasive.”

“This meta-analysis of individual patient data nicely shows using a combination of FIB-4 and LSM-VCTE with lower cutoffs to rule out advanced fibrosis and higher cutoffs to diagnose cirrhosis without the need for liver biopsy,” Dr. Paul, who was not involved in the study, told Reuters Health by email. “Given the disease burden, using this noninvasive testing that is readily available can greatly save healthcare dollars and mitigate patient risk and safety.”

Dr. Stuart C. Gordon, a hepatologist at Henry Ford Health System in Detroit, Michigan, told Reuters Health by email, “Ideally, patient care can be enhanced by wider implementation of these tests in clinical practice.”

But, said Dr. Gordon, who was not involved in the study, “While FIB4 is readily available, transient elastography, unfortunately, is not.”

SOURCE: Gut, online May 17, 2021.

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