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Ionis partner GSK announces bepirovirsen achieves unprecedented functional cure rates with potential to redefine treatment for chronic hepatitis B

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GSK's bepirovirsen achieves 19% functional cure rate in key hepatitis B studies

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Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection

The New York Times

Scientists Find a Potential Cure for Chronic Hepatitis B

Bepirovirsen achieves unprecedented functional cure rates with potential to redefine treatment for chronic hepatitis B

Science

New drug ‘functionally cures’ many hepatitis B virus infections

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AJMC

Bepirovirsen Achieves Clinically Meaningful Functional Cure Rates in Chronic Hepatitis B

National Geographic

A new breakthrough offers hope for a functional cure of hepatitis B

Phase 3 trial results for bepirovirsen, an investigational antisense oligonucleotide developed by GSK and Ionis Pharmaceuticals, were published in the New England Journal of Medicine and presented at the EASL congress in 2026.

Phase 3 trial results for bepirovirsen, an investigational antisense oligonucleotide developed by GSK and Ionis Pharmaceuticals, were published in the New England Journal of Medicine and presented at the EASL congress in 2026.

Pooled data from the B-Well 1 and B-Well 2 trials, conducted across 29 countries with more than 1,838 patients, showed a 19% functional cure rate in the overall study population, compared to 0% in the placebo group.

Pooled data from the B-Well 1 and B-Well 2 trials, conducted across 29 countries with more than 1,838 patients, showed a 19% functional cure rate in the overall study population, compared to 0% in the placebo group.

Among participants with baseline hepatitis B surface antigen at or below 1,000 IU/mL — representing roughly 45% of diagnosed chronic hepatitis B cases globally — a functional cure rate of 26% was recorded, versus 0% in the placebo group.

Among participants with baseline hepatitis B surface antigen at or below 1,000 IU/mL — representing roughly 45% of diagnosed chronic hepatitis B cases globally — a functional cure rate of 26% was recorded, versus 0% in the placebo group.

The current standard of care for chronic hepatitis B typically requires lifelong antiviral therapy, with functional cure achieved in less than 1% of patients. The disease affects more than 240 million people worldwide and causes approximately 1.1 million deaths annually.

The current standard of care for chronic hepatitis B typically requires lifelong antiviral therapy, with functional cure achieved in less than 1% of patients. The disease affects more than 240 million people worldwide and causes approximately 1.1 million deaths annually.

In the pooled safety analysis, serious adverse events occurred in 7% of bepirovirsen recipients versus 4% of placebo patients. The most common adverse events were injection site erythema, local pain and temporary rises in alanine aminotransferase levels.

In the pooled safety analysis, serious adverse events occurred in 7% of bepirovirsen recipients versus 4% of placebo patients. The most common adverse events were injection site erythema, local pain and temporary rises in alanine aminotransferase levels.

Bepirovirsen is under priority review by the FDA with Breakthrough and Fast Track Designation and is also under review in Europe, Japan and China. GSK anticipates the first regulatory decisions in the third quarter of 2026.

Bepirovirsen is under priority review by the FDA with Breakthrough and Fast Track Designation and is also under review in Europe, Japan and China. GSK anticipates the first regulatory decisions in the third quarter of 2026.

GSK Drug Shows 19% Cure Rate for Hepatitis B

GSK Drug Shows 19% Cure Rate for Hepatitis B

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GSK Drug Shows 19% Cure Rate for Hepatitis B

GSK Drug Shows 19% Cure Rate for Hepatitis B

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