Bepirovirsen Cures 20% of Chronic Hepatitis B Patients in Trials, Ahead of Oct. 26 FDA Decision
Updated
Updated · The New York Times · May 28
Bepirovirsen Cures 20% of Chronic Hepatitis B Patients in Trials, Ahead of Oct. 26 FDA Decision
16 articles · Updated · The New York Times · May 28
About 20% of chronic hepatitis B patients given bepirovirsen achieved a functional cure, with no detectable virus 48 weeks after treatment ended; none on placebo were cured.
The weekly injection blocks viral replication and helps the immune system attack a disease that usually requires lifelong therapy and still leaves patients at risk of liver cancer.
The New England Journal of Medicine study pooled more than 1,838 patients across 29 countries in two 24-week trials, though it excluded people with cirrhosis, HIV or very high hepatitis B levels.
More than 1 million people in the U.S. live with chronic hepatitis B, and specialists called the result the first major treatment advance in decades and a major step toward a cure.
Ionis Pharmaceuticals has applied for FDA approval of the drug, developed with GlaxoSmithKline, with a U.S. decision expected by Oct. 26.
A hepatitis B cure is months away, but will its price tag put it out of reach?
If a new hepatitis B drug only cures one in five, is it truly a breakthrough?
After the new 'functional cure,' does the lifelong threat of liver cancer actually disappear?
Bepirovirsen Nears FDA Decision: Phase III Data Signal First Functional Cure for Chronic Hepatitis B
Overview
Bepirovirsen is a promising new treatment for chronic hepatitis B, moving quickly through the regulatory process after receiving both Priority Review and Breakthrough Therapy Designation from the FDA. This accelerated path is supported by strong results from Phase III B-Well 1 and B-Well 2 trials, which showed that bepirovirsen achieved significantly higher functional cure rates, especially when combined with standard care. With a clear FDA decision date set for October 26, 2026, bepirovirsen could soon offer patients a much-needed, effective therapy, marking a major step forward in hepatitis B treatment.