RESPONSE Study Safety

Established safety and tolerability across varied patient populations1,2

In RESPONSE, 193 patients were randomized to receive either LIVDELZI 10 mg (n=128) or placebo (n=65) once daily for 12 months. LIVDELZI or placebo was administered in combination with ursodeoxycholic acid (UDCA) in 94% of patients and as monotherapy in 6% of patients who were unable to tolerate UDCA.1

The table below presents common adverse reactions that occurred in RESPONSE.1

Table depicting the most common adverse reactions (≥5% in LIVDELZI arm) in patients with primary biliary cholangitis in the RESPONSE trial. The most common adverse reactions (LIVDELZI vs placebo) included headache (8% vs 3%), abdominal pain (7% vs 2%), nausea (6% vs 5%), abdominal distension (6% vs 3%), and dizziness (5% vs 2%).Table depicting the most common adverse reactions (≥5% in LIVDELZI arm) in patients with primary biliary cholangitis in the RESPONSE trial. The most common adverse reactions (LIVDELZI vs placebo) included headache (8% vs 3%), abdominal pain (7% vs 2%), nausea (6% vs 5%), abdominal distension (6% vs 3%), and dizziness (5% vs 2%).

PBC=primary biliary cholangitis.

Included 12 patients (6%) who were intolerant to UDCA and initiated treatment as monotherapy: 8 patients (6%) in the LIVDELZI 10 mg arm and 4 patients (6%) in the placebo arm.1

†Occurring in greater than or equal to 5% of patients in the LIVDELZI treatment arm and at an incidence greater than or equal to 1% higher than in the placebo arm.1

‡The gastrointestinal adverse reactions were mild to moderate without the need for discontinuation of LIVDELZI.1

The safety profile included adverse reactions of patients with cirrhosis and those of patients without cirrhosis in both treatment arms.2

References: 1. LIVDELZI [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; 2024. 2. Hirschfield GM, Bowlus CL, Mayo MJ, et al. A phase 3 trial of seladelpar in primary biliary cholangitis. N Engl J Med. 2024;390(9):783-794. doi:10.1056/NEJMoa2312100