Gilead Reports Final Phase III Results for Bulevirtide in Chronic HDV

Gilead Sciences has released final results from its Phase III MYR301 trial evaluating bulevirtide (Hepcludex) in 150 patients with chronic hepatitis delta virus (HDV). The therapy, already approved in the EU since July 2023, demonstrated sustained virologic suppression nearly two years post-treatment for those who achieved undetectable HDV RNA by end of treatment.

In the study, 36% of patients receiving 2 mg or 10 mg daily doses reached virologic suppression. Notably, 90% of those with undetectable HDV RNA at the end of 96 weeks remained off-treatment without viral rebound.

The trial assessed long-term efficacy and safety over 144 weeks. At week 48, primary outcomes included HDV RNA suppression, ALT normalization, and liver stiffness improvement. The delayed-treatment group began 10 mg therapy after 48 weeks.

While bulevirtide 2 mg is approved in Europe and other regions, the 10 mg dose remains investigational and is not approved in the U.S.

17-05-2025