- Gilead Sciences' (GILD, Financial) Phase 3 MYR301 study shows 90% of HDV patients maintained undetectability post-treatment.
- Bulevirtide monotherapy could offer long-lasting virologic suppression for chronic HDV patients.
- Bulevirtide is the only approved treatment for chronic HDV in the EEA and other regions, with varied global regulatory statuses.
Gilead Sciences Inc. (GILD) has announced the final outcomes from its Phase 3 MYR301 study, demonstrating significant results for patients treated with bulevirtide, an entry inhibitor for chronic hepatitis delta virus (HDV). The study, unveiled at the European Association for the Study of the Liver (EASL) Congress 2025, shows promising long-term results with 90% of patients achieving undetectable HDV RNA remaining undetectable for nearly two years post-treatment.
The study included 64 adults with chronic HDV, where 36% maintained virologic suppression after stopping treatment. Particularly noteworthy is that no relapses occurred among those who had sustained undetectability for one year post-therapy. Further insights reveal that participants who achieved HDV RNA undetectability for 96 weeks or more at the end of treatment were most likely to maintain this status, with 90% staying undetectable after discontinuation.
Professor Heiner Wedemeyer, a leading expert in gastroenterology and hepatology, emphasized the potential of bulevirtide in maintaining virologic suppression and improving liver inflammation markers. According to him, these findings highlight the durable response of bulevirtide, supporting its role as a viable treatment method even after cessation.
While bulevirtide 2 mg is the only approved treatment for chronic HDV patients with compensated liver disease in the European Economic Area, the UK, Switzerland, and Australia, it remains under investigation in the U.S. and other regions. Bulevirtide 10 mg is still an investigational product globally.
Gilead Sciences remains committed to exploring bulevirtide's full potential, focusing on monotherapy and combination treatments to enhance outcomes for chronic HDV patients. As the global prevalence of HDV is estimated at 12 million, the company continues to work towards groundbreaking solutions for liver disease.
