FDA Alert

FDA Approves Bulevirtide-gmod (Hepcludex) for Chronic Hepatitis Delta Virus Infection

Ashton L. Stahl

Key Highlights

  • Bulevirtide-gmod (Hepcludex) the first FDA-approved therapy for chronic HDV infection.
  • Approval applies to adults without cirrhosis or with compensated cirrhosis.
  • In Trial MYR301, the combined response at week 48 was 48% with bulevirtide-gmod vs 2% with delayed treatment.
  • The labeling includes a boxed warning about severe acute exacerbations after discontinuation.

The FDA approved bulevirtide-gmod (Hepcludex; Gilead Sciences, Inc) injection for adults with chronic hepatitis delta virus (HDV) infection who do not have cirrhosis or who have compensated cirrhosis. The FDA described bulevirtide-gmod as the first FDA-approved treatment for chronic HDV infection. This serious and life-threatening condition can lead to rapid liver fibrosis, liver cancer, liver failure, and death.

The approval was based on Trial MYR301, a multicenter, randomized, open-label, parallel-arm phase 3 trial. Participants received bulevirtide-gmod 8.5 mg once daily for 144 weeks, either immediately or after a 48-week observation period, followed by 96 weeks of bulevirtide-gmod. At week 48, the combined response rate was 48% in the bulevirtide-gmod group vs 2% in the delayed-treatment group. Undetectable HDV RNA was observed in 20% vs 0% at week 48; rates increased to 36% and 50% at weeks 96 and 144 in the bulevirtide-gmod group.

“Today’s approval fills a critical gap in care for patients with chronic HDV infection,” Wendy Carter, DO, Acting Director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research, said in a press release.

Possible adverse events associated with bulevirtide-gmod include hypersensitivity reactions, including anaphylaxis, injection site reactions, headache, abdominal pain, fatigue, and pruritus. The labeling includes a boxed warning that discontinuing bulevirtide-gmod may result in severe acute exacerbations of HDV and hepatitis B virus infection.

The FDA press release reports a trial dosing bulevirtide-gmod at 8.5 mg once daily for 144 weeks in the immediate-treatment group.

Reference

US Food and Drug Administration. FDA approves first treatment for chronic hepatitis delta virus (HDV) infection. Published May 22, 2026. Accessed May 27, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-hepatitis-delta-virus-hdv-infection