The U.S. Food and Drug Administration approved Hibsago, also called bepirovirsen, for certain adults with chronic hepatitis B who do not have cirrhosis. It is used alongside existing antiviral medicine.
The approval is for a limited group of adults who have already taken hepatitis B medicine for at least six months and meet specific blood-test requirements. In the trials, Hibsago was given for up to 24 weeks, and patients continued their existing medicine for at least 24 weeks after the last injection.
Across two clinical trials, 24 percent of patients who received Hibsago met the requirements to stop their existing medicine, compared with none who received a placebo. Twenty-four weeks after all hepatitis B treatment ended, 19 percent of Hibsago patients still had the virus under control and no detectable hepatitis B surface antigen.
The FDA has not described Hibsago as a cure. It carries boxed warnings for serious liver reactions and low platelet counts, and patients need regular blood tests and follow-up with a health professional.
