FDA approves bepirovirsen for functional hepatitis B cure

The U.S. Food and Drug Administration (FDA) has approved bepirovirsen (Hibsago), the first antisense oligonucleotide treatment for chronic hepatitis B. Clinical trials demonstrated that 19% of patients achieved a functional cure, defined as having undetectable hepatitis B surface antigen (HBsAg) 24 weeks after stopping all antiviral therapy. This success rate significantly exceeds the less than 1% functional cure rate observed with conventional treatments.

Bepirovirsen is administered via subcutaneous injection and is indicated for certain adults without cirrhosis who have undergone at least six months of antiviral therapy and have suppressed HBV levels with HBsAg levels of 3,000 IU/mL or less. Achieving a functional cure is considered a major milestone as it allows patients to potentially cease lifelong medication and reduces the long-term risks of cirrhosis and liver cancer.

Medical experts note that while bepirovirsen represents a significant shift toward functional cures, the field is expanding to include other investigational therapies, such as capsid assembly modulators and gene editing, which aim to target the viral reservoir directly.