Latest Livdelzi Safety, Efficacy Data Presented at The Liver Meeting 2025

New safety and efficacy data for primary biliary cholangitis (PBC) treatment Livdelzi (seladelpar) was presented today at The Liver Meeting, hosted by the American Association for the Study of Liver Diseases (AASLD) 2025 in Washington, D.C., from Nov. 7-11, according to a Gilead news release.

Gilead presented results from the phase 3 ASSURE study, which demonstrated that up to 85% of patients treated with Livdelzi maintained or improved their liver stiffness measurements (LSMs), which are used to assess liver fibrosis, the results of which are reported in kilopascals (kPa). At month 36, the median change from baseline in 114 patients was -0.2 kPa, and those in the higher risk group saw a median reduction of -5.2 kPa. A score of above 10 kPa is associated with an increased risk of liver-related complications.

Livdelzi's effectiveness as a second-line therapy compared to obeticholic acid was also analyzed in 396 patients. Specifically, 266 patients using Livdelzi as second-line therapy and 130 who switched from obeticholic acid. Alkaline phosphatase (ALP) reductions were observed in both groups, with 93% of Livdelzi patients continuing treatment.

Aside from Livdelzi, treatments include ursodiol, which is a naturally occurring bile acid that moves bile from the liver into the small intestine. However, ursodiol is ineffective for up to 40% of patients, and 5% to 10% cannot tolerate it at all.

Obeticholic acid is an alternative treatment but may lead to increased itching and elevations in blood lipids.

"These real-world findings offer encouraging evidence that seladelpar is a viable alternative to obeticholic acid and promising second-line therapy for patients with PBC," said Christopher L. Bowlus, M.D., FAASLD, Lena Valente Professor and chief of the division of gastroenterology and hepatology at the University of California Davis School of Medicine. "ALP is our primary measure of treatment efficacy and the improvements in ALP, across both switch and second-line groups, are clinically meaningful. The safety profile and treatment continuity further support the use of seladelpar for the treatment of patients who previously had limited options.”

Primary biliary cholangitis is a chronic autoimmune disease that results in the progressive destruction of bile ducts in the liver, called the intrahepatic bile ducts. The bile helps digest fat and fat-soluble vitamins in the small intestine, but when the ducts are destroyed, bile builds up in the liver, leading to inflammation and scarring. Over time, this scarring impairs liver function and can lead to cirrhosis and other complications.

Primary biliary cholangitis is more prevalent in women, although researchers are unsure why. In the United States, approximately 65 out of every 100,000 women have PBC, which usually becomes apparent during midlife, between the ages of 45 and 65. There is currently no cure for this disease, but medication can manage symptoms and slow disease progression.

Many patients with PBC are unaware that they have it because there are often no symptoms. As a result, it is usually detected incidentally during routine liver tests. When symptoms are present, pruritus is one of the most common, present in up to 80% of PBC patients. More than half of patients on Livdelzi reported significant itch improvement, maintained for up to 30 months. Itch was measured using the pruritus NRS, 5-D Itch, and PBC-40 Itch domain scores.

Other symptoms can include fatigue, abdominal pain, jaundice and darkening of the skin.