S5-6.3 – Staging and Screening Patients for Rezdiffra Using NITs

S5-6.3 - Staging and Screening Patients for Rezdiffra Using NITs
As panelists ponder practical issues about when and to whom to prescribe Rezdiffra, they consider the benefits and shortcomings of existing NITs.

This conversation focuses on the necessity of using NITs to screen and identify Rezdiffra patients, while at the same time acknowledging the shortcomings of current tests. Panelists suggest some different NIT testing strategies, while commenting on upsides and potential challenges for each MASH NIT.

Laurent Castera joins the conversation at the beginning, which is helpful given his extensive research and knowledge of the surrounding communities. Laurent points out that distinguishing F3 patients from F4 will be a difficult challenge to solve, in part because we used categorical scores for fibrosis instead of recognizing that it is, in fact, a continuum where, in Laurent’s words, “you are not 1.2 or 1.5. You’re F1, 2, 3 or 4.” Having a drug will facilitate a shift from the old-school categorical view to a more linear one.

Laurent goes on to comment that it is not clear exactly how we will use NITs, but that liver stiffness will certainly be one key metric, one he describes as “a prediction scale.” He also comments on the problems caused by relatively low arbitrary cutoffs here, 12.25) and the need for (a) repeat measures and (b) use of at least two tests. He mentions platelet counts as one important example.

Jörn Schattenberg discusses the importance of clinical observation and judgement. Zobair Younossi takes that point further to stress the importance of conservative judgement in assessing for cirrhosis. Laurent suggests that a second, “more specialized test” that is “not related” to VCTE will tremendously improve accuracy.

I comment that one important issue is that individual prescribers will now start treating with Rezdiffra and will derive opinions about the drug based on experiences each has with the first few patients for whom they prescribe. I suggest a similar patterns may be true for NITs, and ask how panelists anticipate providers will receive education on NITs.

Louise Campbell talks about the roadmap that Madrigal showed of what they’re going to have their reps and MSL trained doctors on, and believes that will be exceptionally helpful. She also feels it is vital that practitioners early in the patient visit change also be well-educated on this topic. She notes that many of the people focusing on this topic, including former panelist Suneil Hosmane, now at Madrigal, are first-rate.

Jeff McIntyre closes the conversation by suggesting their will be a “huge patient role,” because patients are people who can demand, or at least ask questions of doctors that will lead the doctor to do things they might not otherwise, and to get more informed on related issues. Jeff notes. that we have not come up with an adequately specific answer to the question, “What’s the best NIT,” which mandates that we keep educating and speaking out.

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