First‑Ever Chronic Hepatitis D Drug Hepcludex Approved in the U.S., Ending 40‑Year Gap

On May 22, 2026, the U.S. FDA granted accelerated approval to Gilead Sciences’ Hepcludex (bulevirtide) for chronic hepatitis D (HDV) infection in adults with or without compensated cirrhosis, becoming the first‑in‑class HDV‑specific therapy in the U.S. and only the second globally, closing a nearly 40‑year treatment gap.

Pivotal Phase III MYR301 data showed: 48‑week combined response rate 48% in immediate treatment group vs 2% in delayed group; HDV RNA undetectable rates increased over time (36% at 96 weeks, 50% at 144 weeks), demonstrating durable long‑term benefit.

HDV is the most severe form of viral hepatitis; co‑infection with HBV drastically increases cirrhosis and HCC risk. Hepcludex blocks viral entry into hepatocytes, ending the “no treatment” era for HDV and offering curative potential for ~1.5 million patients worldwide.