The US Food and Drug Administration (FDA) approved the first treatment for chronic hepatitis delta virus infection, a liver disease that only occurs in people who have hepatitis B virus infection.
Once-daily injections with bulevirtide-gmod, marketed as Hepcludex, demonstrated efficacy in a phase 3 randomized clinical trial. Participants were assigned to either begin immediate treatment with 8.5 mg of bulevirtide-gmod or to wait about 1 year before starting to take the medicine. After about 3 years, participants who had taken the treatment the entire time had a combined response rate—determined by a decline in hepatitis delta virus RNA and aminotransferase normalization—of 48%, compared with 2% in delayed treatment group. Rates of undetectable RNA in the initial treatment group increased over time, from 20% after 1 year to 50% after 3 years.
“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,” Wendy Carter, DO, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release.
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Article Information
Published Online: June 12, 2026. doi:10.1001/jama.2026.8292
