For U.S. users: The VLVbio K18 assays have not been approved by the U.S. Food and Drug Administration

Alcoholic Steatohepatitis

Alcoholic Liver Disease (ALD) and Alcoholic Steatohepatitis (ASH)

Excessive alcohol use is a large global problem where around 300 million people around the world have an alcohol use disorder. This can lead to alcohol associated liver disease (ALD), a chronic liver disease that can further lead to Alcoholic Steatohepatitis (ASH), liver fibrosis and eventually cirrhosis. Routine liver function tests used today often fail to detect and monitor liver damage due to ALD.

Studies show that excessive hepatocyte cell death is a key disease mechanism in chronic and acute liver diseases such as ASH. The VLVbio K18 assays therefore frequently perform better than traditional parameters in the detection of the disease 



M30 Apoptosense® ELISA correlates well with inflammation and fibrosis in patients with ASH 

The M30® and M65® ELISAs have been proven to be more sensitive than traditional biomarkers for the detection of ASH

The M30® and M65® ELISAs can predict non-hepatocellular carcinoma related mortality in patients with cirrhosis due to ALD

The M30® and M65® assays in diagnosing ASH

ASH is challenging to diagnose; a definitive diagnosis requires characteristic clinical and laboratory features with histological confirmation of steatohepatitis on liver biopsy. Given that, readily assayed serum biomarkers that aid diagnosis and prognostication would significantly aid in clinical decision-making. Serum markers of hepatocellular death, the M30 Apoptosense® ELISA and M65® ELISA have shown to be good diagnostic markers in those with alcohol-related liver disease of varying severity.

The M30® values are dramatically elevated in severe ASH, while serum M30® and M65® levels are strongly associated with the presence of steatohepatitis and severity of inflammation on biopsy. With a threshold of M65® at 2,000 U/L, the diagnostic positive predictive value was at 94% for the presence of steatohepatitis on biopsy.

M30® levels also predict the presence of severe inflammation and are associated with clinical outcome, independent of the severity of liver injury at presentation. Application of these thresholds to triage patients to biopsy in and ASH population would result in a dramatic 84% reduction in the numbers requiring biopsy. Furthermore, our biomarker assays can be completed within 24 hours of sample collection. 

The M30® and M65® assays in ASH treatment prediction

Corticosteroids are the first-line treatment option in severe ASH. However, steroids carry a risk of severe adverse events, particularly they predispose to the development of infection. Consequently, careful patient selection is required to ensure those treated derive benefit, and others are not unduly exposed to the risk of infection, especially when liver transplantation remains a potential treatment option.

Given that prednisolone constitutes the only routine treatment option in AH, the M30® and M65® assays give you and idea on the usefulness of this treatment. It has been shown that a specific threshold of serum hepatocyte cell death showed that prednisolone treatment would be beneficial in that individual.

Application of this cutoff in clinical practice could restrict prednisolone usage to around 13% of patients— maximizing benefit while dramatically reducing the risk of steroid related complications. An 824 patient, severe ASH, biopsy controlled study which investigated the VLVbio assays in this patient population, concluded the following: 

“The ability to predict the presence of steatohepatitis on biopsy seen here and the validation of findings from previous studies indicates that K18-M65 should be considered for adoption into clinical practice as a diagnostic adjunct. In addition, K18 has prognostic utility, independent of the MELD score. Finally, K18 may act as a theragnostic biomarker, guiding triage to prednisolone therapy.” (Atkinson et al. 2020)

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