Gilead Receives FDA Approval for Hepcludex in Chronic Hepatitis Delta Virus Infection

Gilead Sciences today announced that the FDA has approved Hepcludex (bulevirtide) for the treatment of adults with chronic hepatitis delta virus (HDV) infection and compensated liver disease. Bulevirtide is an entry inhibitor that blocks HDV and HBV from entering hepatocytes by targeting the sodium taurocholate co-transporting polypeptide (NTCP) receptor. In the Phase 3 MYR301 trial, bulevirtide demonstrated a statistically significant improvement in combined virologic and biochemical response at week 48. This approval provides the first FDA-approved treatment specifically for HDV infection.