FDA approves first treatment for chronic hepatitis delta virus infection

Article excerpt

The FDA has approved Hepcludex (bulevirtide-gmod), an injectable treatment developed by Gilead Sciences for chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. This marks the first FDA-approved therapy specifically targeting HDV, a serious viral infection that compounds liver damage in people already living with hepatitis B. The approval addresses a significant unmet medical need, as hepatitis delta has historically lacked dedicated treatment options despite affecting an estimated 12 million people worldwide. The drug's clearance opens a new therapeutic pathway for patients with this difficult-to-treat condition.