LIVERFASt for assessing and monitoring liver fibrosis, activity and steatosis

Level of innovation

Experts considered LIVERFASt to be a minor variation to current tests for non-alcoholic fatty liver disease (NAFLD). Experts mentioned that other similar technologies are available.

Another expert commented that there are several biomarkers that examine the degree of fibrosis. These are increasingly used in combination with transient elastography and perform well, streamlining diagnostic and referral pathways and the need for liver biopsy. The expert added that there is not enough data to suggest LIVERFASt would improve on this. The assessment of fibrosis, steatosis and inflammatory activity as part of staging non-alcoholic steatohepatitis (NASH) is an area of active research. One expert said that LIVERFASt may be innovative as a minimally invasive test to diagnose NASH.

Potential patient impact

One expert said that the evidence suggested LIVERFASt performed similarly to established fibrosis tests. They considered the benefit of LIVERFASt to be increased choice in tests. Another expert thought that LIVERFASt could reduce the need for transient elastography and liver biopsy. It could also help with treatment decisions in people with coexisting NAFLD and hepatitis B. One expert said that people like to know the severity of their liver disease using rating scales. They thought this could motivate people with NAFLD to make healthy lifestyle changes. But they cautioned that there are other risk factors that need to be considered and relying on LIVERFASt scores alone could be falsely reassuring. There are other tests that assess liver fibrosis and disease activity to detect who may benefit from therapy. But there are currently no licensed treatments for advanced liver fibrosis. Experts said tests to monitor treatment would therefore only be beneficial once these treatments have been developed and used in the NHS.

Potential system impact

Experts advised that LIVERFASt is currently unlikely to replace Fibrosis‑4 (FIB‑4) or transient elastography in people with abnormal liver blood tests. It could be used as a second-line tool or in combination with existing tests to improve diagnostic accuracy. One expert said it would be a major benefit if LIVERFASt could replace FibroScan as the preferred second-line test because this is currently limited by healthcare professional capacity and availability of the device. But more evidence is needed including evidence on the use of LIVERFASt in the NHS care pathway. One expert cautioned that LIVERFASt would not be used to assess chronic hepatitis B or C. But another said it could replace the need for liver biopsy in people with chronic hepatitis B and coexisting NAFLD. Experts commented that LIVERFASt has potential as a minimally invasive test for NASH. NASH is currently diagnosed using liver biopsy and possibly MRI technologies such as Perspectum. LIVERFASt would be cheaper and could be done at scale in primary care. One expert said that testing is being adopted in primary care settings to stratify referrals to secondary care. They believed uptake will increase because of the rising prevalence of liver disease. LIVERFASt could be used for better risk stratification and serial monitoring, but more evidence is needed.

General comments

One expert was uncertain where LIVERFASt would fit into the diagnostic or prognostic pathway. They advised that the clinical context would determine the relevance of the evidence to support its use. Use as a first-line test should be measured against FIB‑4 for ruling out advanced fibrosis in a primary care population. For use as a second-line test, it would need to be compared with transient elastography (FibroScan) and the enhanced liver fibrosis test. This should be in people referred to secondary care for further assessment, either for more accurate staging or because of diagnostic uncertainty. The expert advised that comparison with liver biopsy would be as a third-line test to diagnose NASH in people at risk who were referred to secondary care. The patient and system benefits of using LIVERFASt would depend on how and where the test was used in the NHS. All experts said more evidence is needed to validate the test including larger well-designed studies reported in full-text peer-reviewed papers.