For patients living with Hepatitis Delta virus infection, the question has never been which treatment to use. There was no approved treatment at all. That changed on May 22, 2026.
The U.S. Food and Drug Administration granted accelerated approval to Hepcludex® (bulevirtide-gmod), an 8.5 mg daily subcutaneous injection developed by Gilead Sciences, for the treatment of chronic Hepatitis Delta Virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. It is the first and only approved treatment for HDV in the United States — a landmark that the Hepatitis B Foundation called "a game changer."