FDA approves Hibsago, first antisense therapy for chronic hepatitis B

The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without cirrhosis.

Hibsago is the first FDA‑approved antisense oligonucleotide for this disease. It is indicated for adults without cirrhosis who have been on HBV antiviral therapy for at least six months, have suppressed viral levels, and have hepatitis B surface antigen levels of 3,000 IU/mL or less as measured by an FDA‑authorized test.

The drug targets the genetic instructions the virus uses to replicate, reducing viral load and protein production. Officials said it could allow some patients to maintain control of the virus after completing chronic treatment.

Chronic hepatitis B can progress to cirrhosis and liver cancer, so this new option is viewed as an important advance for patients and clinicians.