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Gilead to Present New Data Advancing Care in PBC and Viral Hepatitis at EASL 2026
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May 13, 2026
- Late-Breaking Livdelzi (Seladelpar) Data Expand the Evidence Base in PBC, while Interim Data Show Durable, Consistent Results Across Key Markers -
- Bulevirtide Data Strengthen Evidence of Efficacy and Safety Across Broad HDV Populations
- New Findings Highlight Progress Toward HCV Elimination and Improved HDV Risk Insight -
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) will present findings from 29 abstracts, including late-breaking presentations at the European Association for the Study of the Liver (EASL) Congress, May 27-30, 2026, Barcelona. These presentations advance understanding of primary biliary cholangitis (PBC) and viral hepatitis.
In PBC, Gilead will present randomized and long-term study data for Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union.
Analyses from the Phase 3 RESPONSE trial ( NCT04620733) will evaluate efficacy and safety in participants with risk factors for disease progress, including elevated liver stiffness and metabolic syndrome.
Interim data from the Phase 3 ASSURE study ( NCT03301506) will assess the relationship between biochemical response and liver stiffness trends over 36 months, including outcomes in individuals with alkaline phosphatase (ALP) levels between 1 to 1.67x the upper limit of normal (ULN).
Together these data provide a multidimensional view of Livdelzi's efficacy, safety and durability across a broad PBC population. Livdelzi is a first-in-class delpar (selective PPAR-delta agonist) indicated for the treatment of PBC to be used in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to UDCA, or as monotherapy for patients unable to tolerate UDCA..
"Primary biliary cholangitis is a chronic, progressive disease where reducing disease activity is critical to improving long-term outcomes. Minimizing impact on quality of life is also key for people living with PBC," said Swati Tole, MD, MS, Senior Vice President, Clinical Development, Inflammation at Gilead Sciences. "At EASL, we are sharing data that further define Livdelzi's potential to address both disease activity and symptoms such as pruritus.".
Advancements in Hepatitis Delta Virus
Presentations will also focus on hepatitis delta virus (HDV), a severe co-infection in people with chronic hepatitis B. The program will include several analyses evaluating investigational bulevirtide, a first-in-class entry inhibitor, in diverse HDV patient populations, reflecting continued efforts to better understand HDV disease management and treatment approaches..
"People living with HDV face a severe disease with limited treatment options. These analyses highlight the breadth of ongoing research and Gilead's continued leadership in advancing the understanding of HDV, including efforts to evaluate Hepcludex across diverse patient populations," said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology at Gilead Sciences. "We remain committed to continuously building on emerging evidence to help improve how this disease is managed over time, and we encourage clinicians to engage with evolving data to help inform care for people living with HDV.".
Analyses from Phase 2 and Phase 3 studies, including MYR301 ( NCT03852719) and MYR204 (NCT03852433) will evaluate clinical, virologic, and biochemical outcomes, as well as safety and tolerability, through 96 weeks across HDV subgroups..
An additional study uses a machine-learning model to identify risk factors for progression to advanced liver disease in adults with HDV infection in the United States..
Advancing Equitable Care for Hepatitis B and C.
Additional presentations highlight progress across viral hepatitis, including HBV cure research, long-term disease management, and HCV elimination efforts..
• In hepatitis B, Gilead will present data from its cure research program, including studies of GS-2829 and GS-6779, evaluating HBeAg loss and immune biomarkers.
• In hepatitis C, presentations highlight real-world elimination efforts and patient-centered outcomes.
Marketing Authorizations for Bulevirtide
In July 2023, the European Commission granted full Marketing Authorization (MA) for Hepcludex (bulevirtide) 2 mg for the treatment of adults with chronic hepatitis delta virus (HDV) infection and compensated liver disease (conditional approval was received in July 2020). Hepcludex 2 mg also has full marketing authorization in the United Kingdom, Switzerland, Australia, Canada, United Arab Emirates, Israel and Kuwait.
Bulevirtide is not approved in the United States. In the U.S. and other regions where it is not authorized, bulevirtide 2 mg is an investigational product, and its safety and efficacy have not been established or approved by the U.S. Food and Drug Administration (FDA) or other health authorities.
Bulevirtide 10 mg, GS-2328 and GS-6779 are investigational and not approved anywhere globally. The safety and efficacy of these programs have not been established.
U.S. Indication for Livdelzi
Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
full press release:
https://www.gilead.com/news/news-details/2026/gilead-to-present-new-data-advancing-care-in-pbc-and-viral-hepatitis-at-easl-2026
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