Surfing the MASH Tsunami continues its 2023 wrap-up conversations with hepatology researcher, key opinion leader and 2023 UEG Rising Star of the Year Hannes Hagstrom, along with co-hosts Louise Campbell and Roger Green. The conversation focuses largely on issues in diagnostics and clinical care pathways.
The conversation starts with Hannes describing highlights of 2023 as positive drug trials, excellent in-person meetings and the new nomenclature. Asked to clarify, he focuses on how the new nomenclature focuses on the interaction of alcohol consumption and what was previously called “non-alcoholic” disease. As a second point, he discussed the ability to use non-invasive tests (NITs) as replacement for biopsy, if not entirely appropriate today, at some point in the near future.
Roger asks Hannes whether he has seen an impact of defining MetALD as a separate disease and including alcohol on the steatotic spectrum, he says he has not seen much yet, perhaps a little confusion about the new name (which he sees as necessary in any transition and appropriately timed now.
Roger asks Hannes whether he sees any “storm clouds” in 2023. Hannes sees two points for concern: the pace at which regulatory agencies acknowledge the value of NITs in diagnosis and early signs of confusion around clinical care pathways.
To Hannes, the entire community should prioritize simplification and streamlining to the degree possible. For example, primary care practitioners (PCPs) will send diabetes patients to ophthalmologists to test for retinopathy, after which the specialists will take responsibility for the specific condition but leave basic care to the PCP. He questions whether hepatologists have the bandwidth to play a similar role. Roger notes an earlier discussion (S4 E50.3), in which Naim Alkhouri mentions PCPs’ concern that hepatologists will “steal” total care of the MASLD patient. Hannes notes that European systems do not operate this way. Louise comments that in the UK, 95% of all scans require no new treatment, which means that a nurse-based system can pinpoint challenges and spread workload among appropriate specialties. To her, this makes pathway development “absolutely key.”
Hannes asks Roger for historical context on this issue. Roger suggests that acceptance of the importance of MASLD feels to him similar to the final acceptance of the cholesterol hypothesis in the 1980s, but in terms of drug development and treatments, more like hypertension in the 1950s when there were multiple modes of action available, none of which were efficacious for most patients as monotherapies. He also notes that we do not know which care paradigms will hold (his example: oncology, with its induction vs. maintenance drug choices and cycles).
He notes the group is looking at many issues, most of which focus on prediction modeling and treatment response. One project he describes focuses on providing a prediction model that is meaningfully superior to FIB-4 and is based on primary care practices, not clinical trial groups. He also describes work on “emulated target trials,” in which the researcher can compare historical data to current clinical trials using advanced statistical techniques. The goal here is to create comparisons on a range of questions, including intention to treat and protocol effects. Finally, Hannes mentions beginning work on treatment response markers, where his team is in the early stages, partly because there are no approved drugs to support these analyses in a larger population.
In 2024, Hannes sees potential “game changers” as coming not only from drug development (and hopefully approvals), but also work on diagnostic markers and new kinds of multi-center, multi-region collaborations that will create larger, richer and more diverse data sets than researchers have today.