November 12, 2025
5 min watch
PHOENIX — In this video, Barry Crittenden, MD, discusses data from the RESPONSE and ASSURE trials of patients with primary biliary cholangitis who were treated with Livzelzi, with or without prior use of fibrates or obeticholic acid.
“We thought it was important to evaluate whether people who had used these therapies previously could achieve a biochemical response and maintain a good safety profile and good tolerability if they switched to seladelpar,” Crittenden, executive director of clinical development at Gilead Sciences, told Healio.
Results presented at ACG Annual Scientific Meeting showed Livdelzi (seladelpar, Gilead Sciences) demonstrated composite biochemical response, regardless of previous treatment with fibrates or obeticholic acid (OCA).
Specifically, in the phase 3 placebo-controlled RESPONSE trial, 45% of patients receiving seladelpar who were previously treated with fibrates or OCA achieved a composite biochemical response vs. 65% of those without prior treatment.
At month 6 of the ongoing, open-label ASSURE safety trial, there was a “very similar” proportion of patients who achieved biochemical response, regardless of prior fibrate or OCA use, which ranged from 60% to 78%, Crittenden said.
These findings suggest patients with primary biliary cholangitis previously treated with fibrates or OCA “will have a similar benefit from seladelpar in terms of efficacy and safety compared to patients who had not been previously treated.”
For more information:
Barry Crittenden, MD, can be reached at anna.blyth@gilead.com.
Sources/Disclosures
Source:
Healio Interviews
Reference:
- Villamil A, et al. Efficacy and safety of seladelpar in patients with primary biliary cholangitis previously treated with fibrates or obeticholic acid. Presented at: ACG Annual Scientific Meeting; Oct. 24-29, 2025; Phoenix (hybrid meeting).
Disclosures:
Gilead Sciences funded these studies. Crittenden reports no relevant financial disclosures.
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