FDA approves GSK’s Hibsago for chronic hepatitis B
GSK•The FDA approved GSK’s Hibsago (bepirovirsen) for chronic hepatitis B in eligible adults without cirrhosis. The six-month treatment is used with nucleos(t)ide analogue therapy; Phase III trials showed a 19% functional cure rate versus 0% with placebo among patients with HBsAg levels of 3,000 IU/ml or lower.
1. Approval and trial results
The FDA approved GSK’s Hibsago (bepirovirsen) for chronic hepatitis B in eligible adults without cirrhosis. The six-month treatment is used with nucleos(t)ide analogue therapy, and self-administration is available following the first dose. Phase III trials showed a 19% functional cure rate versus 0% with placebo in patients with HBsAg levels of 3,000 IU/ml or lower.
