Could hepatitis B finally have a finite treatment option? Tatyana Kushner, MD, joins hosts Nancy Reau, MD, and Kimberly Brown, MD, to break down the phase 3 B-Well data for bepirovirsen, the first agent to hit functional cure as a primary endpoint in chronic hepatitis B.
The conversation covers the phase 3 B-Well 1 and B-Well 2 results, published in the New England Journal of Medicine and presented at EASL 2026, and why quantitative HBsAg testing is becoming essential to patient selection ahead of a potential approval. Kushner, Reau, and Brown also work through what functional cure actually means for patients, how it compares to spontaneous HBsAg loss, and what dosing and monitoring are likely to look like given signals for ALT elevation and renal effects seen in the trials. They discuss which patients are unlikely to be candidates, including those with cirrhosis or decompensated liver disease, and close with a look at what an approval could mean for hepatitis B screening rates and referral patterns between primary care and specialty hepatology.
Bepirovirsen is not yet FDA approved. The FDA has accepted the New Drug Application for priority review, with a PDUFA goal date of October 26, 2026.
For more: https://www.hcplive.com/view/liver-lineup-bepirovirsen-and-the-push-toward-functional-cure-in-hepatitis-b