A potential game-changer for hepatitis B just landed. The FDA approved bepirovirsen (Hibsago), the first drug of its kind to offer a functional cure for adults with chronic hepatitis B on antiviral therapy. In phase III trials, nearly 1 in 5 patients achieved functional cure — compared to zero in the placebo group — marking what researchers are calling "the start of a new era."
The FDA has approved bepirovirsen (Hibsago), a first-of-its-kind antisense oligonucleotide therapy that offers adults with chronic hepatitis B (CHB) — who have no cirrhosis and are on antiviral therapy — the possibility of a functional cure. Developed by GSK, the drug is administered as a 6-month course and can be self-injected after the first dose, making it a practical option for eligible patients.
Approval was based on the B-Well 1 and B-Well 2 phase III trials, which showed that bepirovirsen, used alongside background antiviral therapy, enabled some patients to maintain viral control even after all CHB treatment ended — something no prior therapy had achieved.
Chronic HBV infection is a leading driver of cirrhosis and liver cancer — responsible for more than half of liver cancer cases globally. Bepirovirsen's approval represents the first real shot at a functional cure, offering patients a defined treatment window rather than lifelong antiviral suppression. Clinicians should note the boxed warning for serious hepatic flares, thrombocytopenia, and kidney function risks, requiring regular blood monitoring during treatment.
