by Lori Solomon

The U.S. Food and Drug Administration has approved Hepcludex (bulevirtide‐gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or compensated cirrhosis. Approval of Hepcludex was granted to Gilead Sciences.

Hepcludex received priority review and was approved under the Accelerated Approval pathway. It also received Breakthrough Therapy Designation and Orphan‐Drug Designation. There is aboxed warningthat discontinuation of Hepcludex may result in severe acute exacerbations of HDV and hepatitis B virus infection.

The approval was based on results from a Phase III trial in which participants were randomly assigned to immediate treatment with Hepcludex (8.5 mg once daily for 144 weeks) or to delayed treatment following a 48‐week observational period.

At week 48, the rate of undetectable HDV RNA (less than the lower limit of quantification of 50 IU/mL) was 20% in the Hepcludex group versus 0% in the delayed treatment group. At weeks 96 and 144, the rate ofundetectable HDV RNAincreased to 36 and 50%, respectively, in the Hepcludex group.

"Today's approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA‐approved therapies available," Wendy Carter, D.O., from the FDA Center for Drug Evaluation and Research, said in a statement.

"For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications."

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Key medical concepts bulevirtide Clinical Trials, Phase III as Topic Hepatitis B