Gilead to Showcase New Data on Liver Disease Treatments at EASL 2025 Congress
核心洞察
Gilead will present 29 abstracts at the European Association for the Study of the Liver (搜索) Congress in May 2025, highlighting advancements in treatments for primary biliary cholangitis (搜索) and viral hepatitis.
New data will demonstrate Livdelzi's (seladelpar) effectiveness in reducing pruritus (搜索) in primary biliary cholangitis (搜索) patients and bulevirtide's potential for maintained virologic response in hepatitis delta virus (搜索) treatment.
The company will also present promising results from a Phase 1a study of a novel therapeutic vaccine aimed at achieving functional cure for hepatitis B (搜索) virus infection.
Gilead Sciences announced plans to present significant new research across multiple liver disease areas at the upcoming European Association for the Study of the Liver (搜索) (EASL) Congress, taking place May 7-10, 2025, in Amsterdam. The presentations will showcase the company's continued commitment to advancing treatments for both rare and common liver conditions.
Advancements in Primary Biliary Cholangitis Treatment
New data from Gilead will reinforce the effectiveness of Livdelzi (seladelpar), known as Lyvdelzi in the European Union, for treating primary biliary cholangitis (搜索) (PBC). The presentations will include a subgroup analysis from the ongoing ASSURE open-label study and an analysis of the Phase 3 RESPONSE trial with its open-label extension.
The data will demonstrate seladelpar's ability to reduce pruritus (搜索) (chronic itch), a debilitating symptom experienced by many PBC patients. Additionally, results will highlight the drug's capacity to deliver sustained biochemical responses regardless of patients' prior treatment history, positioning it as a viable option for a broad range of people with PBC.
"Our deep expertise in treating liver disease has delivered the first and only treatment for hepatitis delta and the first treatment for primary biliary cholangitis (搜索) that has demonstrated statistically significant improvements across both chronic itch and markers of disease progression," said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences.
Breakthrough Data in Viral Hepatitis
Among the 29 abstracts accepted for presentation, two oral presentations will showcase new data on maintained virologic response following treatment with bulevirtide in people living with hepatitis delta virus (搜索) (HDV). The presentations will include findings on both 2 mg and 10 mg dosages, building on existing long-term data for chronic HDV treatment.
A late-breaking presentation will reveal the final results from the pivotal MYR301 Phase 3 study, evaluating the efficacy and safety of bulevirtide monotherapy. This presentation will disclose long-term response rates, including the proportion of participants maintaining undetectable virus levels two years after treatment cessation.
Progress Toward Hepatitis B Functional Cure
In the hepatitis B (搜索) (HBV) space, Gilead will present initial results from a Phase 1a study of a novel investigational therapeutic vaccine (GS-2829 and GS-6779) showing early promise toward achieving a functional cure for HBV infection. This represents a significant step in addressing a disease that affects millions globally.
Additional HBV research will include a real-world data analysis demonstrating that individuals with low-level HBV viremia still face risks of negative outcomes. A retrospective analysis of participants from two Phase 3 studies evaluating Vemlidy (tenofovir alafenamide) will highlight the importance of treatment in reducing liver cancer risk.
Real-World Evidence in Hepatitis C Treatment
The company will also showcase real-world data on hepatitis C (搜索) virus (HCV) treatment, demonstrating the effectiveness of direct-acting antivirals (DAAs) against all genotypes across diverse geographical regions. This data supports the global applicability of HCV treatment guidelines.
New insights will reveal how the choice of DAA for people living with HCV who are taking other medications, such as antipsychotics, can reduce drug-drug interaction problems—an important consideration for optimizing treatment outcomes in complex patients.
Patient-Centered Initiatives
Beyond scientific presentations, Gilead will support EASL's "Love Your Liver" campaign to raise awareness about HCV and encourage screening. The company will also launch "All the Feelings with PBC," a campaign highlighting the experiences of people living with PBC, in collaboration with the PBC Foundation (搜索) and Friends of the PBC Foundation.
This patient-centered initiative will feature artwork by Berlin-based artist Nour Khwies, based on the physical and emotional experiences of PBC patients from Germany, Scotland, Portugal, and the United States.
Regulatory Status of Key Treatments
Livdelzi (seladelpar) received accelerated approval from the U.S. FDA in August 2024 for the treatment of PBC, with conditional approval from the UK MHRA in January 2025. The European Commission granted conditional marketing authorization for Lyvdelzi in February 2025. Regulatory reviews are ongoing in Canada, Australia, and Switzerland.
For hepatitis delta, the European Commission granted full Marketing Authorization for Hepcludex (bulevirtide) 2 mg in July 2023, following an initial conditional approval in July 2020. The UK converted bulevirtide's conditional license to full authorization in August 2023, with Switzerland granting full approval in February 2024. In the U.S. and other regions where bulevirtide is not yet approved, it remains an investigational product.
"Our focus remains on addressing the areas of greatest unmet need across liver diseases," Dr. Berger emphasized. "Our studies continue to deliver transformational insights and therapies to help foster healthier futures for the millions of people who live with viral hepatitis and those who live with less prevalent liver conditions with remaining high unmet needs."
The EASL Congress presentations will provide healthcare professionals and researchers with valuable insights into the latest advancements in liver disease treatment, reinforcing Gilead's position as a leader in this therapeutic area.