Gilead’s phase 3 MYR301 study demonstrating longer treatment with Bulevirtide was associated with sustaining undetectability after stopping treatment

Gilead Sciences recently announced their final results from the pivotal Phase 3 MYR301 study revealing that 36% of adults living with chronic hepatitis delta virus treated with the first-in-class entry inhibitor bulevirtide at either a 2 mg or 10 mg dose maintained virologic suppression for almost two years after stopping treatment after achieving undetectable HDV RNA at end of treatment. In participants who sustained undetectability for one year after end of therapy, no relapses occurred in the second year of follow-up. In addition, sustained post-treatment undetectable HDV RNA was more frequent in participants with longer on-treatment HDV RNA undetectability at end of treatment: 90% of those who had HDV RNA undetectability for ≥ 96 weeks at end of treatment remained HDV undetectable off-treatment. These new data, presented at the European Association for the Study of the Liver (EASL) Congress 2025, show the potential value of bulevirtide monotherapy for some adults living with chronic HDV, even after treatment has ended.

“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,” said Professor Heiner Wedemeyer, Head and Chair of the Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology at Hannover Medical School. “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.”

“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,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead. “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.”

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gilead, Gilead Sciences, Phase 3 MYR301 Study