Health Rounds: New blood test matches gold standard for liver disease diagnosis

By Nancy Lapid

Nov 5 (Reuters) - Hello Health Rounds readers! Today we feature two studies being presented at The Liver Meeting, the annual gathering of the American Association for the Study of Liver Diseases, which got underway on Thursday in Denver.

“Liquid biopsy” stages liver disease from blood sample

An experimental blood test precisely determines the extent of patients’ chronic liver disease, researchers reported on Thursday at the AASLD meeting in Denver.

The test’s performance on routine blood samples matched that of magnetic resonance elastography, the most accurate non-invasive method for assessing liver disease.

MRE is largely confined to specialist centers and clinical trials, however.

While currently available blood tests can detect liver cancer, they cannot tell whether and to what extent patients’ livers are affected by metabolic dysfunction-associated steatohepatitis, or MASH, a condition involving inflammation and scarring that can advance to cirrhosis and liver failure.

Establishing the stage of MASH today requires MRE or a liver biopsy.

The new test, LiquidTransformer from Hepta, determines liver biology from DNA circulating in blood.

"For years, MRE imaging has been the non-invasive benchmark we rely on in our research. It’s the most accurate way we have to stage liver fibrosis without a biopsy,” Dr. Rohit Loomba, of UC San Diego, Hepta's chief medical and scientific adviser, said in a statement.

Working with Hepta and Madrigal Pharmaceuticals MDGL.O, which sells Rezdiffra, the first approved MASH therapy, researchers showed the test accurately staged patients’ liver damage and identified those who were eligible for the drug.

In other experiments, the technology also distinguished between the three forms of steatotic liver disease: MASLD, driven by metabolic dysfunction; ALD, driven by alcohol; and MetALD, where the two coexist.

In patients receiving the GLP-1 drug semaglutide, LiquidTransformer detected molecular changes attributable to the drug. Semaglutide — sold by Novo Nordisk NOVOb.CO as Wegovy for weight loss and Ozempic for diabetes — is known to provide liver benefits and has been approved in the US to treat MASH. Whether the drug has independent effects on the liver unrelated to weight loss has not been established.

Overall, in six separate AASLD presentations, LiquidTransformer was reported to be nearly as accurate as MRE and even more accurate than second-line alternatives, such as an ultrasound method known as vibration-controlled transient elastography and another blood test called the enhanced liver fibrosis test.

“Seeing a blood test approach the diagnostic accuracy of MRE and beat (other alternatives) at determining treatment eligibility is a real step forward, as that is an important unmet need given the wider availability and access of a blood test," Loomba said.

Ipsen drug improves level of hard-to-control liver enzyme

Most patients with an inflammatory liver disease that had not completely responded to the usual treatment experienced significant liver-function improvement after receiving Ipsen's IPN.PA Iqirvo, according to data from a late-stage trial.

The study tested Iqirvo as a second-line treatment in 92 patients with primary biliary cholangitis who still had slightly to moderately elevated levels of a liver enzyme called alkaline phosphatase, or ALP, despite treatment with ursodeoxycholic acid.

ALP levels above normal have been associated with active disease and greater need for liver transplant, whereas normalization is associated with better complication-free survival, the researchers noted.

One year into the trial, 85.3% of patients receiving Iqirvo achieved normal ALP levels, compared with 23.3% receiving placebo, the researchers plan to report at the liver meeting.

The average ALP reduction from baseline was 36.5% with Iqirvo versus 4.2% with placebo. The data was also published on Thursday in Hepatology.

More patients treated with Iqirvo, known chemically as elafibranor, achieved normalization across multiple liver-related laboratory measures, including ALP, total bilirubin, other enzymes, albumin, and international normalized ratio, a marker of blood clotting activity.

An editorial published with the study points out that while the results show that Iqirvo can achieve ALP reductions even when the starting point is not particularly high, they do not yet show that doing so changes patients’ disease course, relieves symptoms, or is clearly worth the risks in low-risk patients.

“The next question is no longer whether ALP normalization can be achieved, but in whom achieving it changes long-term clinical outcomes enough to justify treatment escalation,” Dr. Raj Vuppalanchi of the Indiana University School of Medicine wrote in the editorial.