On May 22, 2026, Gilead Sciences announced announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex^® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States.

The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotransferase (ALT), supported primarily by data from the pivotal, controlled Phase 3 MYR301 study. At Week 48, the study demonstrated a statistically significant improvement versus the control (delayed treatment) group in a combined virologic and biochemical response. Improvement in disease-related clinical outcomes has not been established. Continued approval for the approved indication may be contingent on verification and description of clinical benefit in a confirmatory trial.

Chronic HDV is considered the most severe form of viral hepatitis and is associated with a markedly higher risk of rapid disease progression, liver failure, and mortality compared with HBV alone. In the United States, studies in general populations have estimated that HDV affects between 2% and 4% of individuals who have chronic hepatitis B virus (HBV), representing ~40,000-80,000 people.

MYR301 (NCT03852719) evaluated the efficacy and safety of Hepcludex in adults with chronic HDV, with treatment administered for up to 144 weeks followed by 96 weeks of off-treatment follow-up. Hepcludex met its primary endpoint at Week 48, with continued treatment, demonstrated sustained efficacy and was generally well tolerated through up to 144 weeks of on-treatment exposure.

The Gilead Support Path^® Program offers information and resources to help patients diagnosed with chronic HBV, HDV and hepatitis C virus (HCV) and primary biliary cholangitis (PBC), as well as healthcare professionals, understand coverage and financial options for prescribed Gilead treatments. Bulevirtide 2 mg is also approved for use in the European Economic Area (EEA) and other countries globally to treat people living with chronic HDV.