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FDA approves Hibsago, first antisense drug for chronic hepatitis B

Partly verified · 4/5 supported1 cited · 1 min read

The U.S. Food and Drug Administration approved Hibsago (bepirovirsen) injection, to be used with existing antiviral therapy, for treating chronic hepatitis B virus infection in certain adults without cirrhosis . Hibsago is the first FDA‑approved antisense oligonucleotide for chronic hepatitis B . Approval is limited to adults without cirrhosis who have been on HBV antiviral therapy for at least six months, have suppressed HBV levels, and have hepatitis B surface antigen levels of 3,000 IU/mL or less, as measured by an FDA‑authorized test . The treatment is intended to give some patients the possibility of maintaining control of the virus after completing chronic HBV therapy .

Why it matters. It provides certain patients the chance to maintain viral control after stopping chronic HBV treatment, potentially reducing long‑term medication use .

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