The U.S. Food and Drug Administration approved Hibsago (bepirovirsen) injection on October 20, 2026. The drug is the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B.

Hibsago is approved to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis. The treatment is indicated for use in combination with existing antiviral therapy for adults who have been taking HBV antiviral therapy for at least six months, have suppressed levels of HBV in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test. Primary source: fda.gov

"For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed," Wendy Carter said. "Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended."

"This approval represents an important advance for people living with this serious disease," Carter said.

Hibsago works by targeting the genetic instructions the virus uses to make copies of itself and viral proteins, which helps reduce the amount of virus and hepatitis B surface antigen. Chronic hepatitis B is a long-term liver infection caused by HBV that can lead to serious liver disease, including cirrhosis, and increase the risk of liver cancer over time.

What's New

The FDA authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic to identify patients eligible for Hibsago treatment based on HBsAg levels. Research titled "Bepirovirsen: The first antisense oligonucleotide approved to achieve a functional cure for chronic hepatitis B" was published in 2026 in Drug Discoveries & Therapeutics. Primary sources: doi.org, fda.gov