S5 - E11.1 - How The Rezdiffra Approval Has Affected How One Clinic Manages MASH Patients

Surfing the MASH Tsunami

In this initial conversation, Michael Charlton describes some ways that the presence of Rezdiffra has affected practices and procedures in his clinic and shares issues he and his colleagues are discussing.
As the conversation begins, Michael hails Rezdiffra as proof that as a species, "we can be capable of amazing things in a good way," a drug approved by FDA to reverse fibrosis in a significant number of patients with the world's most common liver disease. From there, he goes on to discuss the challenges his metabolic live disease clinic faces in prescribing the drug. The first issue: the label provides "tremendous latitude" in defining the target F2/F3 patient properly.

Jörn Schattenberg asks about the patients coming to his clinic and how much knowledge they possess of the disease and medication. He also asks how Michael discusses Rezdiffra with them.

Michael describes a clinic with hepatology and endocrinology, nutrition support and a group of nurses all of whom can do elastography. Some patients want medication, others seek to care for themselves first through nutrition and physical activity plans. In all cases, the clinic takes a holistic approach, particularly because most patients have at least one more metabolic complication.

Michael shifts to a second issue: futility. The label does not include information on treatment-stopping criteria. He alludes briefly to a leading KOL group that is creating "something to help the field" decide which patients to treat and when to stop therapy, among other issues.

Jörn asks whether the clinic is setting up a new panel of test for these patients, Michael states that the clinic relies mostly on standard tests: FIB-4, ELF, FibroScan, and, for patients above a certain threshold, MRI.