NASH Best Practices in NITs

This conversation about NASH Best Practices starts with Quentin Anstee sharing the five key takeaways for NITs in general and NIT Best Practices he developed while preparing recent talks for the Liver Forum and the ICFL meeting in Vienna:

1. As we have discussed on this podcast and elsewhere, trial endpoints around balloon hepatocytes are, in Quentin’s words, “not sufficiently robust.”
2. Rapidly attaining response from a given test (ALT, for example) is not necessarily a guarantee of early efficacy.
3. “Simple indirect biomarker panels like FIB-4” need to be interpreted with caution.
4. Since we do not have a single perfect gold standard test (neither histological nor non-invasive), we should consider a standard for clinical trial assessment that is a composite of multiple different types of tests, perhaps one liquid, one physical (MRE?) and one histological.
5. We need to develop a battery of NITs that are both applied and reported in all cases, instead of running large numbers of NITs and only reporting the ones that support the targeted medication.

This conversation goes on to focus on points #2 and #3, which touch on the relationship between early blood test results and proof of endpoint efficacy.