Gilead announces final results from MYR301 study

Gilead (GILD) announced final results from the pivotal Phase 3 MYR301 study revealing that 36% of adults living with chronic hepatitis delta virus treated with the 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 Congress 2025, show the potential value of bulevirtide monotherapy for some adults living with chronic HDV, even after treatment has ended. The findings build on data, presented at The Liver Meeting 2024, hosted by the American Association for the Study of Liver Diseases, from MYR301 which demonstrated a subset of participants treated with bulevirtide monotherapy had undetectable HDV RNA 48 weeks after stopping treatment. This presentation adds further insight by not only showing the durability of response post-treatment, but that sustained undetectability was more frequent in people with longer, on-treatment HDV RNA undetectability at the time of bulevirtide discontinuation. Furthermore, post-treatment hepatic serious adverse events were reported in 14% of participants but were resolved in 85% (17/20) of these participants, most of whom restarted bulevirtide therapy.