– New Three-Year Interim Data Demonstrates Livdelzi May Help Stabilize or Improve Liver Health in PBC Patients –

Gilead Sciences, Inc. will present new research that reinforces its commitment to advancing innovation for people living with liver disease at The Liver Meeting 2025, hosted by the American Association for the Study of Liver Diseases (AASLD), November 7-11 in Washington, D.C. Key findings from more than 35 accepted abstracts across PBC and viral hepatitis will include late-breaking data and three oral presentations.

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Primary Biliary Cholangitis Research

Three late-breaking presentations will share new data on Livdelzi  in people living with primary biliary cholangitis , including real-world treatment experience following the withdrawal of obeticholic acid , liver stiffness outcomes from a three-year interim analysis of the ongoing ASSURE study , and long-term pruritus data from the RESPONSE trial and its open-label extension (#LB5015). These studies explore how Livdelzi is being used in clinical practice, its potential impact on liver health, and patient-reported experiences with itch over time.

“The data we’re sharing at The Liver Meeting reflect our continued dedication to advancing science that meaningfully improves the lives of people affected by liver disease,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead. “These interim long-term findings in PBC deepen our understanding of disease progression and highlight the potential to help improve patients’ liver health and symptoms.”

Viral Hepatitis Research

Gilead also plans to share new data from across its viral hepatitis portfolio. In hepatitis delta virus (HDV), Gilead will present integrated analyses from the MYR204 and MYR301 studies, investigating the long-term safety and efficacy of bulevirtide for the treatment of chronic HDV. Gilead will also present an analysis from the Phase 3 ALLIANCE study that aims to study HIV/HBV co-infected participants who achieved hepatitis B virus surface antigen (HBsAg) loss, a marker of HBV functional cure, after starting tenofovir-based treatments. Lastly, data from a Phase 1b study on the safety, tolerability and antiviral efficacy of GS-2829 and GS-6779, novel investigational therapeutic HBV vaccines, among virally suppressed participants with chronic hepatitis B, will be presented.

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FOCUS: Gilead Commitment to Collaboration and Public Health

The FOCUS program is a public health initiative that enables partners to develop and share best practices in routine blood-borne virus (HIV, HCV, HBV) screening, diagnosis and linkage to care. Two presentations will underscore how innovative approaches and strategic partnerships are driving measurable progress to help combat viral hepatitis and HIV.

  • Dr. Su Wang, from Cooperman Barnabas Medical Center, will present a model for resilient public health infrastructure through an automated electronic medical record (EMR)-based screening program. The initiative demonstrates how health systems can leverage technology to maintain robust monitoring systems, identify individuals with viral infections and offer linkage to care. This approach exemplifies how local action can help sustain national public health priorities in the face of potential decreases in federal funding.
  • Meanwhile, the Kentucky Department for Public Health will share results from a pilot program that introduced point-of-care HCV RNA testing in community settings serving people who use drugs and those experiencing homelessness. By integrating rapid diagnostics into routine care, the initiative highlights how targeted implementation can help remove systemic barriers, accelerate linkage to care, and improve health equity for vulnerable populations.

Together, these efforts reflect the transformative potential of data-driven strategies and public-private collaboration in advancing public health goals and strengthening public health systems.

Gilead Commitment to Advocacy

At The Liver Meeting2025, Gilead will launch Reflecting Realities, a campaign dedicated to capturing the emotions and real experiences of people living with liver conditions. Reflecting Realities brings together two campaigns: “BehinD the SilenCe” in collaboration with the World Hepatitis Alliance (WHA) and All the Feelings with PBC in collaboration with the PBC Foundation and Friends of the PBC Foundation. “BehinD the SilenCe” highlights the experiences of people living with viral hepatitis and will feature portrait photographs of people living with viral hepatitis and audio testimonials of their lived experience. These campaigns aim to showcase the real impact of liver disease and facilitate more meaningful conversations between people living with liver disease and their healthcare providers.

Additionally, Gilead will announce which independent emerging investigators Gilead has selected to participate in its Research Scholars Program in PBC. The objective of the program is to support innovative research that aims to close scientific knowledge gaps and address unmet medical needs.

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Source- businesswire