— In phase III study, patients taking bulevirtide had ALT normalization and steep drops in HDV RNA
May 26, 2026
• 2 min read
Chronic hepatitis delta virus (HDV) infection has its first FDA-approved treatment, after the agency granted accelerated approval to bulevirtide (Hepcludex) injection for adults without cirrhosis or with compensated cirrhosis.
The most severe form of viral hepatitis, HDV infection only occurs in people with hepatitis B virus (HBV) infection and brings greater risks of disease progression, liver failure, and mortality than HBV alone. An estimated 40,000 people in the U.S. have chronic HDV. Bulevirtide blocks entry of both HBV and HDV into liver cells.
