November 13, 2025
3 min watch
PHOENIX — In this video, Barry Crittenden, MD, discusses data that show Livdelzi appears safe for second-line treatment of patients with primary biliary cholangitis with cirrhosis and clinical signs of portal hypertension.
Crittenden, executive director of clinical development at Gilead Sciences, and colleagues pooled safety data from the phase 3, placebo-controlled ENHANCE and RESPONSE trials, which assessed Livdelzi (seladelpar, Gilead Sciences) in this patient population over a 12-month period.
The researchers compared incidence of adverse events and liver-related complications between seladelpar and placebo.
According to Crittenden, “adverse events were common but occurred at a similar rate or less frequently” among patients treated with seladelpar compared with placebo (71% vs. 83%).
“Overall, there were no new safety concerns identified in this high-risk population, which just reinforces that seladelpar appears safe and well tolerated in PBC patients in general, and including those with cirrhosis and portal hypertension,” Crittenden said.
For more information:
Barry Crittenden, MD, can be reached on LinkedIn here.
Sources/Disclosures
Source:
Gulamhusein A, et al. Safety of seladelpar in primary biliary cholangitis patients with cirrhosis and clinical signs of portal hypertension: Data from the ENHANCE and RESPONSE studies. Presented at: ACG Annual Scientific Meeting; Oct. 24-29, 2025; Phoenix (hybrid meeting).
Disclosures:
Crittenden reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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