FDA approves hepatitis B shot that may let some patients stop all treatment

The FDA has approved GSK's Hibsago (bepirovirsen) for adults with chronic hepatitis B who have no cirrhosis, have received antiviral treatment for at least 6 months, have viral suppression, and have low HBsAg levels. In two clinical trials, 24% of patients given Hibsago met the criteria for stopping treatment (0% on placebo), and 19% still maintained virologic control with undetectable HBsAg 6 months after stopping, which GSK calls a functional cure. The drug carries a boxed warning for severe liver reactions and thrombocytopenia that can cause life-threatening bleeding, requiring frequent blood monitoring.