Noninvasive methods as good as biopsy for NAFLD prognosis, meta-analysis finds

Noninvasive tests perform as well as biopsy for prognosis in nonalcoholic fatty liver disease (NAFLD), a meta-analysis found.

Researchers conducted a meta-analysis of individual-participant data on the prognostic performance of histologically assessed fibrosis stage, liver stiffness measured by vibration-controlled transient elastography (LSM-VCTE), fibrosis-4 index (FIB-4), and NAFLD fibrosis score (NFS). They included data on 2,518 patients with biopsy-proven NAFLD from 25 studies (44.7% women; median age, 54 years; 46.1% with type 2 diabetes). Results were published by The Lancet Gastroenterology & Hepatology on June 5.

The primary outcome was a composite end point of all-cause mortality, hepatocellular carcinoma, liver transplantation, or cirrhosis complications (i.e., ascites, variceal bleeding, hepatic encephalopathy, or progression to a Model for End-Stage Liver Disease score ≥15). After a median follow-up of 57 months, the primary outcome occurred in 5.8% of the patients. At five years, the time-dependent receiver-operating characteristic curves were 0.72 (95% CI, 0.62 to 0.81) for histology, 0.76 (95% CI, 0.70 to 0.83) for LSM-VCTE, 0.74 (95% CI, 0.64 to 0.82) for FIB-4, and 0.70 (95% CI, 0.63 to 0.80) for NFS. All index tests were significant predictors of the primary outcome.

The authors concluded that the noninvasive tests performed as well as histologically assessed fibrosis in predicting clinical outcomes in patients with NAFLD and that they could be considered as alternatives to liver biopsy in some cases. They also noted that most data came from Europe and Asia, with very few cases from Australia and North America.

Although liver biopsy “underpinned the emergence of hepatology as a medical specialty,” it has become redundant in many contexts, the authors said. “NAFLD remains one of the last areas of hepatology for which liver biopsy is used for disease-staging purposes. We hope that our data provide the first validation step towards the use of non-invasive tests instead of histology by clinicians and regulators for the ultimate benefit of patients,” they wrote.

An accompanying editorial agreed that the study shows “clinicians in non-hepatology settings can now assess the risk of future liver-related complications without the need for liver biopsy” but cautioned that “successful implementation and uptake of the use of non-invasive tests in non-hepatology settings will require greater engagement with clinicians, including delivery of targeted education, and access to relevant tests.”