Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
Gilead has announced final data from its Phase III MYR301 clinical trial of bulevirtide in patients with chronic hepatitis delta virus (HDV). At either a 2 mg or 10 mg dose, the first-in-class entry inhibitor maintained virologic suppression for almost two years following treatment after achieving undetectable HDV RNA at end of treatment in 36% of adults living with HDV who were treated. Data from the study were presented at the European Association for the Study of the Liver (EASL) Congress 2025.1
Bulevirtide produced even more encouraging results in patients with longer on-treatment HDV RNA undetectability at end of treatment. Data show 90% of those who had HDV RNA undetectability for ≥ 96 weeks at end of treatment remained HDV undetectable off-treatment.
In a press release, Professor Heiner Wedemeyer, MD, head and chair of the department of gastroenterology, hepatology, infectious diseases, and endocrinology at Hannover Medical School, said: “HDV is the most severe form of viral hepatitis with more rapid progression towards liver cancer and liver-related death. Previous data have demonstrated the potential of bulevirtide as a safe and effective treatment option and, as EASL and the European Medicines Agency guidelines recommend, continued treatment is encouraged as long as people are experiencing a clinical benefit. With today’s results, we’re now seeing the potential of bulevirtide to maintain virologic suppression and normalize markers of liver inflammation for a subset of people living with HDV, demonstrating a durable response, even after treatment cessation.”
The Phase III MYR301 study evaluated the long-term efficacy and safety of bulevirtide in 150 patients living with chronic HDV. Participants were randomized to receive the treatment at a dose of either 2 mg once-daily or 10 mg once-daily. The primary assessment occurred at 48 weeks, which was then followed by participants in the delayed treatment arm switching to bulevirtide 10 mg once daily for an additional 96 weeks. The primary endpoint was combined response, defined as an undetectable HDV RNA or ≥2log10 IU/ml decline from baseline and ALT normalization at 48 weeks.
“At Gilead, we are committed to advancing research and exploring the full potential of bulevirtide as a monotherapy, in combination, and at different doses, to help improve outcomes for people living with chronic HDV. Previous results from MYR301 demonstrated the potential benefits of long-term treatment with bulevirtide. With this new data, we now have valuable insight into the durability of the response even after treatment has ended,” Anu Osinusi, vice president, clinical research for hepatitis, respiratory, and emerging viruses at Gilead, added in the press release.
In June 2023, Gilead shared 96-week data from MYR301. Results from the time showed additional improvements in combined response at week 96 compared with week 48, with no signs of treatment resistance. An additional analysis revealed that patients who appeared to not respond or only partially respond to bulevirtide at week 24, went on to achieve a virologic response at 96 weeks with continued bulevirtide as monotherapy.2
In a press release from the time, Wedemeyer said: “This latest data adds to the growing body of evidence establishing bulevirtide as an effective and well tolerated treatment for HDV when used for a longer duration. Importantly, we saw a response at 96 weeks even in people who initially showed only a partial decline in HDV viral load.”
The European Commission (EC) granted full Marketing Authorization (MA) for Hepcludex (bulevirtide) 2 mg for the treatment of adults with chronic HDV and compensated liver disease in July 2023. Bulvertide 2 mg is not currently approved in the US, among other regions, while bulvertide 10 mg is not approved anywhere globally.
References
1. Final Data From the Phase 3 MYR301 Study Demonstrated Longer Treatment With Bulevirtide Was Associated With Sustaining Undetectability After Stopping Treatment. News release. Gilead. May 7, 2025. Accessed May 7, 2025. https://www.businesswire.com/news/home/20250506030074/en/Final-Data-From-the-Phase-3-MYR301-Study-Demonstrated-Longer-Treatment-With-Bulevirtide-Was-Associated-With-Sustaining-Undetectability-After-Stopping-Treatment
2. Hepcludex® (Bulevirtide) Demonstrates Sustained Efficacy and Safety Profile in People With Chronic Hepatitis Delta Virus at 96 Weeks. News release. Gilead. June 23, 2023. Accessed May 7, 2025. https://www.businesswire.com/news/home/20230622999800/en/Hepcludex-Bulevirtide-Demonstrates-Sustained-Efficacy-and-Safety-Profile-in-People-With-Chronic-Hepatitis-Delta-Virus-at-96-Weeks
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
