Safety Considerations With OCA in PBC

Edward Mena, MD: We have to use obeticholic acid with caution in patients who have cirrhosis. You really want to look at patients without portal hypertension.

Kris Kowdley, MD, FACP, FACG, AGAF, FAASLD: That’s a good point. Can you tell us, David, about how the recommended use of obeticholic acid has changed since 2021, when there was a label update and cautioned use in patients with decompensated liver disease and portal hypertension?

David Victor III, MD: I think most importantly, let’s first say what decompensated liver disease is. It is not necessarily the patient who comes into your office and has a child’s class of A when you calculate it in the office. Anyone who’s had a variceal bleed, evidence of significant ascites, or a decompensating event should be considered as having decompensated cirrhosis for the face of obeticholic acid use. That’s because in those patients, the drug is not metabolized or removed as quickly, or so I understand. Kris, you probably can speak better to the science than I, but it can cause toxicity and make the liver worse. So, No. 1, you must make sure if they’ve ever had a decompensating event, you probably want to be very careful; if not, avoid obeticholic acid use. The indolent are best patients with cirrhosis or those nearing cirrhosis. You want to monitor them much more carefully than someone who has early disease on obeticholic acid because you may want to stop therapy if their portal hypertension progresses or you see changes that would increase their risk of toxicity to the medicine.

Kris Kowdley, MD, FACP, FACG, AGAF, FAASLD: That’s an important point. Patients with cirrhosis can be treated, but patients with cirrhosis and clinically significant portal hypertension should not be treated. Patients with decompensated cirrhosis—although in the past we used to have guidelines suggesting that they could be treated but start at once a week, etc—they’re no longer candidates for treatment.

Transcript edited for clarity