After years of “take this pill forever,” hepatitis B patients just got a shot at stopping treatment entirely.
The FDA has approved Hibsago (bepirovirsen) from GSK and Ionis. It’s the first drug offering a functional cure for chronic hepatitis B, which means the virus stays under control even after all treatment stops.
The numbers are what make it a big deal. In the phase 3 B-Well trials, six months of treatment cleared the virus to undetectable levels in 19% of patients. On placebo, nobody got there.
In patients with lower levels of the virus’s surface antigen, the rate went up to 26%.
Today’s standard antivirals manage that in about 1% of patients.
It’s approved for adults without cirrhosis, alongside their existing therapy.