Gilead Reports Long-Term Data on Livdelzi Reinforcing Safety and Efficacy in PBC

Gilead Sciences has presented new long-term and real-world data supporting the safety and efficacy of Livdelzi (seladelpar) in people living with primary biliary cholangitis (PBC). The findings, shared at The Liver Meeting 2025 hosted by the American Association for the Study of Liver Diseases (AASLD), indicate durable biochemical and clinical benefits over three years of treatment.

In real-world analyses involving 396 patients, 130 had switched from obeticholic acid while 266 used Livdelzi as second-line or monotherapy following its U.S. approval in late 2024. Both groups demonstrated reductions in alkaline phosphatase (ALP), a key marker of disease activity, with most achieving levels below 1.67×ULN. Safety parameters remained stable, and 93% of participants continued treatment through the observation period.

“ALP is our primary measure of treatment efficacy, and the improvements observed across switch and second-line groups are clinically meaningful,” said Dr. Christopher L. Bowlus, Chief of Gastroenterology and Hepatology at the University of California, Davis. He noted that the data support seladelpar as a viable alternative to obeticholic acid for patients with limited treatment options.

New interim results from the Phase 3 ASSURE study (NCT03301506) also showed sustained improvement or stability in liver stiffness among 85% of participants after up to three years of Livdelzi therapy. Among 114 participants evaluated at Month 36, the median change from baseline was −0.2 kPa (−2.9%), with the highest-risk subgroup (baseline 16.9 kPa) showing a median reduction of −5.2 kPa (−29.7%).

“These data underscore Livdelzi’s potential to alter the course of PBC by addressing liver stiffness, a key marker of disease progression,” said Dr. Dietmar Berger, Chief Medical Officer at Gilead. “The greatest benefit was observed in patients at highest risk.”

Further findings from ASSURE indicate 67% of participants (82/122) achieved a composite biochemical response, while 34% (41/122) reached normalized ALP levels after three years of treatment. No treatment-related serious adverse events were reported, and no new safety concerns emerged after up to four years of exposure. Results align with prior findings from the pivotal Phase 3 RESPONSE trial, which formed the basis for FDA approval in 2024.

Additional analyses highlighted Livdelzi’s impact on pruritus, one of the most common and burdensome symptoms of PBC. Over half of patients with moderate to severe itch reported meaningful improvement, with benefits sustained for up to 30 months. Improvements were measured using validated tools, including the Pruritus Numeric Rating Scale (NRS), 5-D Itch Scale, and PBC-40 Itch Domain.

Beyond clinical data, Gilead also introduced a patient-centered education initiative, Your Guide to Living Well with Primary Biliary Cholangitis, developed in collaboration with Viver Health and advocacy groups. The program provides practical resources for symptom management and shared decision-making.

Livdelzi, a PPAR-delta agonist, received accelerated FDA approval in August 2024 for use in combination with ursodeoxycholic acid (UDCA) or as monotherapy in adults unable to tolerate UDCA. Continued approval may depend on confirmatory evidence from ongoing trials.

PBC is a chronic autoimmune liver disease affecting approximately 130,000 people in the United States, predominantly women. The condition causes progressive bile duct damage, which can lead to liver failure if untreated. Current therapies aim to slow disease progression and alleviate symptoms such as fatigue and chronic itch.

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