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Navigating Developments in PBC Treatment, with Allison Moser, MSN, RN, FNP

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Moser reviews ongoing unmet needs in PBC and how the addition of 2 new second-line treatment options has changed the treatment landscape.

The primary biliary cholangitis (PBC) treatment landscape has undergone significant developments in the past few months with the addition of 2 new second-line treatment options, seladelpar (Livdelzi) and elafibranor (Iqirvo).

At the 2024 annual Gastroenterology and Hepatology Advanced Practice Providers (GHAPP) conference in National Harbor, Maryland, Allison Moser, MSN, RN, FNP, Solid Organ Transplant Lead Advanced Practice Provider at Rush University Medical Center, spotlighted these advancements during her presentation on emerging emerging therapies in the management of PBC.

Ursodeoxycholic acid (UDCA) has long served as the first-line treatment option for patients diagnosed with PBC. Although it has demonstrated a notable impact on transplant-free survival and the development of fibrosis and esophageal varices, Moser noted as many as 40% of patients do not have an adequate response to treatment and 5% are unable to tolerate it.

“When [obeticholic acid] came out, it was really exciting that we had a second-line therapy for these patients who were either unable to tolerate UDCA or had an inadequate response,” Moser told HCPLive. “But even with that, there's still a large percentage of patients who have an inadequate response with obeticholic acid, about 50%. So although it does have great efficacy, there's still quite an unmet need.”

With the accelerated approvals of elafibranor and seladelpar in June 2024 and August 2024, respectively, Moser described a new excitement around PBC and how the emergence of these new treatment options has helped to “put PBC in the spotlight again.”

She called attention to the rapid and sustained efficacy of both medications, describing how treatment goals and timelines have shifted in light of these therapeutic developments. Looking ahead, Moser highlighted the potential of triple therapy, describing it as “really exciting,” especially in the context of an FXR agonist and a PPAR.

References

  1. Brooks, A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed September 17, 2024. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis
  2. Brooks, A. FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC. HCPLive. June 10, 2024. Accessed September 17, 2024. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-elafibranor-iqirvo-for-pbc

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