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The use of Agile scores based on vibration-controlled transient elastography (VCTE) accurately predicted liver-related events in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), according to a cohort study.

Among over 16,000 patients, incidence of liver-related events was 0.7 per 1,000 person-years in those with a baseline Agile 3+ score for advanced fibrosis of less than 0.451, 3.3 per 1,000 person-years in those with a score between 0.451 to 0.678, and 24.9 per 1,000 person-years in those with a score of 0.679 or greater (P<0.001), reported Vincent Wai-Sun Wong, MD, of the Prince of Wales Hospital in Hong Kong, and colleagues.

Meanwhile, incidence of liver-related events was 1.2 per 1,000 person-years in patients with a baseline Agile 4 score for cirrhosis of less than 0.251, 23.5 per 1,000 person-years for those with a score between 0.251 to 0.842, and 105.5 per 1,000 person-years for those with a score of 0.843 or greater (P<0.001), they noted in .

The researchers also assessed the accuracy of serial Agile scores in the 65.8% of patients who underwent another VCTE after a median 15 months: 81.9% had stable Agile 3+ scores, and 92.1% had stable Agile 4 scores.

MASLD, previously known as nonalcoholic fatty liver disease (NAFLD), affects about Americans and more than a third of the global population. MASLD is a leading cause of cirrhosis and liver cancer, with a dose-dependent relationship between the severity of liver fibrosis and the risk of liver-related events, including hepatocellular carcinoma, liver transplant, and death.

Liver biopsy is currently the most accurate way to stage hepatic fibrosis, necessitating more noninvasive options. This study's findings suggested that VCTE is a viable noninvasive alternative to liver biopsy for predicting the progression of MASLD.

Wong and team compared the accuracy of VCTE-derived Agile 3+ scores for advanced fibrosis and Agile 4 scores for cirrhosis with histologic tests and the following other noninvasive tests: liver stiffness measurement (LSM); aspartate aminotransferase (AST) to alanine aminotransferase (ALT) ratio; FibroScan-AST; Fibrosis-4 index; NAFLD fibrosis score; AST to platelet ratio index; and the BMI, AST:ALT ratio, and diabetes (BARD) score.

"In the baseline model, both the Agile 3+ and Agile 4 scores had the highest overall accuracy in predicting liver-related events," the authors wrote. "Although the difference in prognostication between the Agile scores and LSM might be marginal, the Agile scores were stable over time, and changes in the scores over time provide insights that can affect clinical management."

The area under the receiver operating characteristic (AUROC) ranged from 0.87 to 0.91 for Agile 3+ and Agile 4 scores compared with a range of 0.86 to 0.88 for histologic fibrosis stage, 0.86 for LSM, and 0.66 to 0.86 for the fibrosis scores.

"By pairwise comparison, the AUROC for liver-related events of both Agile scores was significantly higher than histologic fibrosis staging and other comparator fibrosis tests at 3 and 5 years, with the exception of a similar performance between the Agile scores and LSM at 3 years," the authors wrote. "The Agile scores better reclassified patients with and without liver-related events at 3 and 5 years according to their risk compared with LSM, while other noninvasive tests generally had a similar or reduced correct reclassification compared with LSM."

In an , Zobair M. Younossi, MD, MPH, of the Global NASH Council at the Center for Outcomes Research in Liver Disease in Washington, D.C., highlighted the importance of having noninvasive tests in clinical practice that can both exclude patients who don't have cirrhosis and identify patients with significant fibrosis, bridging fibrosis, or cirrhosis.

"Currently, most single noninvasive tests have good negative predictive value but lack adequate positive predictive value to identify patients with MASLD who are considered at high risk of adverse outcomes," Younossi wrote, adding that it's particularly important to identify patients with significant fibrosis without cirrhosis because such patients "may be treatment candidates for upcoming drug regimens in patients with MASLD."

He noted that the study results revealed a reduction in the risk of a liver-related event in patients with a high Agile 3+ score at baseline who have a score decrease of at least 20%, though the Agile 4 score's predictive ability was not as high.

"The finding that a reduction in the score could potentially reflect a reduction in the risk of liver-related events in these high-risk patients and thus provide another marker of disease regression is valuable in clinical practice," Younossi wrote.

For this study, the researchers analyzed data collected mostly prospectively from a cohort of 16,603 adults with MASLD who underwent VCTE at one of 16 centers in the U.S., Europe, or Asia from February 2004 to January 2023. All patients had been diagnosed by histology (with steatosis in at least 5% of hepatocytes) or imaging (ultrasound, CT, MRI, or controlled attenuation parameter).

Mean age was 52.5, 57.8% were men, and 81.8% were from Asia. Just over a third (34.7%) had diabetes and/or hypertension (34.8%). Among the 3,532 patients with liver biopsy, 33.5% had F3 or F4 fibrosis.

Patients were excluded if they had a history of chronic viral hepatitis, HIV, excessive alcohol consumption, cancer, hepatic decompensation, liver resection or transplant, or hepatic steatosis from steroids or similar secondary causes.

The primary outcome was liver-related events, including hepatocellular carcinoma, liver transplant, liver-related deaths, or hepatic decompensation (ascites, variceal hemorrhage, hepatic encephalopathy, or hepatorenal syndrome). After a median follow-up of 51.7 months, 1.9% of patients had liver-related events, including 139 cases of hepatocellular carcinoma and 209 cases of hepatic decompensation.

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