Clinical Trial Shows New Drug Achieves Functional Cure in One in Five Hepatitis B Patients
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A new drug, bepirovirsen, achieved a functional cure in approximately 19% of patients with chronic hepatitis B in a large global trial, a rate significantly higher than the current standard of care. This development could change the course of a disease that currently requires lifelong medication for most patients. Pharmaceutical company GSK has submitted the data to regulators in multiple regions, with approval decisions expected this year.
Facts First
- Bepirovirsen achieved a functional cure in 19% of trial participants, compared to about 3% with current treatments.
- The B-Well trial enrolled 1,838 adults across 29 countries who received weekly injections for six months.
- GSK has submitted the data to regulators in the United States, Canada, Europe, Japan, and China.
- Approval decisions for bepirovirsen are expected in 2024, following regulatory review.
- The drug works by blocking viral protein production and triggering an immune response.
What Happened
Results from a major global clinical trial published in the New England Journal of Medicine show that the drug bepirovirsen achieved a functional cure in approximately one in five patients with chronic hepatitis B. The current standard of care achieves this outcome in only about three percent of patients. The B-Well trial involved 1,838 adults across 29 countries who received either a weekly injection of bepirovirsen or a placebo for six months, while continuing their existing antiviral medication.
Why this Matters to You
If you or someone you know is among the more than 240 million people living with chronic hepatitis B worldwide, this development may introduce a new treatment option that offers a chance to be free of the virus without medication. Current treatments suppress the virus but rarely clear it, often requiring patients to remain on lifelong medication. A functional cure could potentially reduce the long-term risk of liver damage, liver failure, and liver cancer associated with the disease.
What's Next
Pharmaceutical company GSK has submitted the trial data to regulators in the United States, Canada, Europe, Japan, and China. Approval decisions for bepirovirsen are expected in 2024. If approved, the drug would represent a significant new tool in managing a global health burden that causes over one million deaths each year.