Gilead to Present New Liver Disease Research at AASLD 2024 Meeting

Gilead Sciences, Inc. has unveiled its latest research which will be showcased at The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD) from November 15-19 in San Diego, California. Their research portfolio includes over 40 abstracts, with significant attention given to primary biliary cholangitis (PBC), hepatitis Delta virus (HDV), hepatitis C virus (HCV), and nonalcoholic steatohepatitis (NASH)/fibrosis.

In PBC research, 11 abstracts will be presented, featuring data from the RESPONSE trial which demonstrates the efficacy and safety of Livdelzi (seladelpar) in individuals with PBC and compensated cirrhosis. The study also explores the impact of Livdelzi on pruritus, a chronic itching condition that adversely affects the quality of life for PBC patients. Additionally, interim results from the ongoing ASSURE study highlight the long-term efficacy and safety of Livdelzi.

Furthermore, Gilead’s presentation will include an interim analysis of the Phase 3 MYR301 study, which evaluates HDV patients treated with bulevirtide monotherapy for different durations (2 mg for 144 weeks, 10 mg for 144 weeks, and 10 mg for 96 weeks) and assesses their virological and biochemical responses 48 weeks after treatment cessation. This study also includes a 144-week analysis of patient-reported outcomes for those treated with bulevirtide 2 mg, contributing to the growing body of data on long-term treatment for chronic HDV.

Anu Osinusi, Vice President of Clinical Development at Gilead Sciences, conveyed the company’s enthusiasm about their research contributions at The Liver Meeting. She emphasized Gilead’s dedication to advancing science that can transform the lives of those living with liver diseases. Osinusi highlighted the comprehensive nature of their research, which spans both viral and inflammatory liver diseases, reinforcing Gilead’s commitment to improving health outcomes through awareness, education, screening, diagnosis, and long-term care.

Gilead is also set to present data on HCV, including safety and tolerability outcomes for Epclusa (velpatasvir/sofosbuvir) in pregnant individuals with chronic HCV as part of the STORC study. This research could help clinicians better support pregnant individuals with HCV, potentially reducing the risk of transmission to infants. Real-world findings from the SVR10K study on HCV will also be shared, demonstrating the effectiveness of direct-acting antivirals against all HCV genotypes across various regions. Additionally, late-breaking data from a Phase 2a open-label study will be presented, evaluating the safety and efficacy of new combination therapies for chronic hepatitis B virus (HBV).

Highlighted abstracts at AASLD 2024 include studies on the efficacy and safety of seladelpar in PBC patients, the long-term safety of seladelpar treatment, and the effects of bulevirtide monotherapy for chronic HDV. Other significant presentations will cover various aspects of HCV treatment, including outcomes in pregnant individuals and real-world data on antiviral effectiveness, as well as studies on HBV and NASH/fibrosis.

The European Commission granted full Marketing Authorization for bulevirtide 2 mg for treating adults with chronic HDV and compensated liver disease in July 2023. This authorization was extended to Great Britain, Switzerland, and Australia in 2024.

Gilead Sciences has been at the forefront of liver disease research for decades, significantly impacting the treatment landscape for hepatitis C, hepatitis B, and delta hepatitis. Their ongoing research and development efforts aim to provide advanced treatments for liver diseases, ultimately striving for a future free of liver ailments. Through their pioneering science and collaborative efforts, Gilead is dedicated to enhancing the lives of people with liver diseases, continuing their mission to create a healthier world.