Hepatitis Month in Review: May
The FDA's accelerated approval of bulvirtide for chronic hepatitis D headlined May's news. Learn more about the treatment's phase 3 clinical trial including its efficacy, safety profile, and clinician insights. May also included Viral Hepatitis Awareness Month and National Hepatitis Testing Day. Listen to a clinician talk about the significance of these awareness events.
The FDA approved bulevirtide-gmod (Hepcludex; Gilead Sciences) injection on May 22, 2026, marking a historic regulatory milestone: the first approved treatment for chronic hepatitis delta virus (HDV) infection in the United States.1 The approval covers adults without cirrhosis or with compensated cirrhosis and was granted to Gilead Sciences, Inc. under the FDA's Accelerated Approval pathway, with Priority Review, Breakthrough Therapy Designation, and Orphan-Drug Designation all previously conferred on the agent.