GSK’s Bepirovirsen Achieves Phase III Success in Chronic Hepatitis B

GSK’s investigational antisense oligonucleotide bepirovirsen has delivered positive results in two Phase III trials, marking a significant advance in the treatment of chronic hepatitis B (CHB). The B-Well 1 and B-Well 2 studies, which enrolled more than 1,800 patients across 29 countries, met their primary endpoint, showing that bepirovirsen combined with standard of care led to significantly higher functional cure rates than standard therapy alone.

All key secondary endpoints were also met, with particularly strong efficacy seen in patients with lower baseline hepatitis B surface antigen levels. The drug was generally safe and well tolerated across both trials.

Based on these results, GSK plans to submit regulatory filings for bepirovirsen to global health authorities. If approved, the therapy could redefine treatment goals in CHB, where current therapies rarely achieve functional cure and often require lifelong use.

10-01-2026