Gilead announces new Livdelzi long-term data

Gilead (GILD) announced new long-term data reinforcing the safety and efficacy profile of Livdelzi for people living with primary biliary cholangitis. Findings support Livdelzi’s consistent efficacy and safety outcomes in patients switching from obeticholic acid and positive impact on liver stiffness over three years. These findings were presented at The Liver Meeting hosted by the American Association for the Study of Liver Diseases in Washington, D.C. Late-breaking, real-world data on Livdelzi, the only PBC treatment that provides statistically significant reductions across key biomarkers of disease and itch vs. placebo, support Livdelzi as an effective and well-tolerated alternative for patients switching from obeticholic acid, and as a second-line therapy. Among 396 patients analyzed, 130 switched from obeticholic acid and 266 used Livdelzi as second-line or monotherapy based on data available since U.S. approval in late 2024. Reductions in alkaline phosphatase were observed in both groups, with most patients achieving ALP levels below 1.67ULN. Safety labs remained stable, and 93% of patients continued Livdelzi treatment throughout the observation period. Gilead will present late-breaking interim results from its Phase 3 ASSURE study, showing Livdelzi’s potential to improve liver health in people with PBC. After up to three years of treatment, 85% of participants maintained or improved their liver stiffness measurements. Among 114 participants with data at Month 36, the median change from baseline was -0.2 kPa. Notably, those in the highest-risk group saw a median reduction of -5.2 kPa. These findings build on data shared at The Liver Meeting 2024 and underscore Livdelzi’s role in addressing this progressive and underrecognized disease. New interim results from the open-label Phase 3 ASSURE trial show that 67% of participants with PBC achieved a composite biochemical response, while 34% reached normalized ALP levels after three years of treatment with Livdelzi. These results are consistent with those from the pivotal Phase 3 RESPONSE trial and underscore Livdelzi’s potential to meaningfully impact disease progression and pruritus symptom burden in PBC. Livdelzi continues to show a robust safety profile, with no treatment-related serious adverse events and no new safety signals after up to four years of exposure. These findings align with the efficacy and safety results from the two and half year efficacy and three year safety interim results presented at The Liver Meeting 2024. New data from the pivotal RESPONSE study and its open-label extension, ASSURE, show that Livdelzi delivers sustained and meaningful reduction in chronic itch-a debilitating symptom affecting up to 80% of people with PBC. Among patients with moderate to severe itch at the start of treatment, over half reported significant improvement, including those who switched from placebo. Benefits were maintained for up to 30 months and supported with validated patient-reported measures such as the pruritus NRS, 5-D Itch, and PBC-40 Itch domain scores. Notably, the pruritus numeric rating scale used throughout both studies underwent rigorous psychometric validation, demonstrating its reliability and sensitivity to change in the open-label ASSURE study – reinforcing Livdelzi’s long-term efficacy profile. Additional analysis from RESPONSE showed that Livdelzi not only reduced itch severity but also impacted the burden itch places on daily life, including the ability to engage in social activities, complete household tasks, and participate in work or school. It also reduced the spread of itch across the body. A separate analysis suggests that Livdelzi may offer meaningful improvements in PBC-related itch, which can impact quality of life for people living with this chronic condition, not just those experiencing moderate or severe itch.