Gilead Sciences announced that it would share its latest liver disease research at the European Association for the Study of the Liver (EASL) Congress 2023. It aimed to present a wide range of findings, including important data from over 70 presentations.
Gilead aims to highlight the 96-week Hepcludex (bulevirtide) data in hepatitis D-infected patients. This study focuses on assessing the efficacy and safety of bulevirtide as a treatment for hepatitis delta virus (HDV). Additionally, Gilead will present late-breaking data on the long-term effects of bulevirtide treatment.
Gilead stated that it will also present real-world data reflecting its commitment to the World Health Organization's (WHO) goal to eliminate viral hepatitis by 2030. The company will share efforts and initiatives to achieve this goal, including data on the impact of various treatments.
Furthermore, Gilead will present long-term results from studies evaluating Vemlidy (tenofovir alafenamide) in chronic hepatitis B (HBV) patients. These findings contribute to the understanding of HBV treatment outcomes and provide insights into the effectiveness of Vemlidy.
The presentations will include advancements in the treatment of HDV and HBV. Notably, the latest Week 96 data from the pivotal Phase 3 MYR301 study of bulevirtide will be presented, demonstrating progress in treating chronic HDV patients. Additionally, data will be shared on the benefits of continued treatment with bulevirtide for 96 weeks in non- and partial-responders. These findings highlight the safety and efficacy of bulevirtide and emphasize the importance of prolonged therapy for individuals living with HDV, a particularly severe form of viral hepatitis.
In HBV, Gilead will present the final 8-year safety and efficacy data from two global Phase 3 studies. These studies evaluated the long-term outcomes of chronic HBV patients initially treated with either tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) and subsequently switched to TAF. The data is aimed to provide insights into these treatments' long-term effects and effectiveness.
Gilead stated that the company is committed to advancing the understanding and treatment of liver diseases.
Merck stated that it would present new findings on efinopegdutide (MK-6024), an investigational GLP-1/glucagon receptor co-agonist, at the upcoming EASL Annual Congress.
The data presentation will feature results from a Phase 2a clinical trial that investigated the effectiveness of efinopegdutide in adult patients suffering from nonalcoholic fatty liver disease (NAFLD).
In addition, efinopegdutide received Fast Track Designation from the FDA in the US as a potential treatment for nonalcoholic steatohepatitis (NASH) in patients. NASH is a more severe form of NAFLD, characterized by liver inflammation and damage. Fast Track Designation is a regulatory process that expedites the development and review of drugs to treat severe conditions with unmet medical needs. Currently, there are no approved therapies explicitly targeting NASH.
NAFLD is a chronic and progressive condition characterized by fat accumulation in the liver. NASH, closely linked to obesity, pre-diabetes, and diabetes, represents an advanced stage of NAFLD involving liver inflammation and damage.