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    REG - GSK PLC - Positive Phase 3 data for bepirovirsen

    Picture of GSK logoGSKAnnouncement
    28/05/2026 09:30
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RNS Number : 0470G  GSK PLC  28 May 2026

Issued: 28 May 2026, London UK

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

·      Pivotal B-Well data show a significant 19% functional cure in the
overall study population and 26% in patients with lower viral activity
compared to 0% with standard of care only 1  (#_edn1)

·      49% of bepirovirsen recipients achieved a surface antigen level
of ≤100 IU/mL one year after end of treatment in exploratory analysis

·      A loss in surface antigen is associated with a significant
reduction in risk of liver cancer 2  (#_edn2)

·      Over 240 million people worldwide live with chronic hepatitis
B 3  (#_edn3)

 

GSK plc (LSE/NYSE: GSK) today announced positive pivotal data for
bepirovirsen, its investigational antisense oligonucleotide (ASO) for the
treatment of chronic hepatitis B (CHB). Results from the two phase III trials,
B-Well 1  NCT05630807  and B-Well 2  NCT05630820 , were simultaneously
published in the New England Journal of Medicine and presented at the European
Association for the Study of the Liver (EASL) congress.(1)

 

Pooled data from both trials showed that 6-month treatment with bepirovirsen
achieved a statistically significant and clinically meaningful 19% functional
cure response rate (233 of 1,220 vs. 0 of 614 in the placebo group i  (#_ftn1)
, with p<0.001 in both trials) in the overall study population (adults with
≤3000 IU/ml hepatitis B surface antigen (HBsAg) level), meeting the primary
endpoints. In a key secondary endpoint, a functional cure rate of 26% (200 of
768 vs. 0 of 393 in the placebo group, with p<0.001 in both trials) was
achieved in participants with ≤1000 IU/ml HBsAg level, a group that
represents approximately 45% of diagnosed CHB cases globally. 4  (#_edn4) The
current standard of care typically requires lifelong therapy, with functional
cure rates achieved in less than 1% of patients. 5  (#_edn5)

 

Functional cure occurs when the hepatitis B virus (HBV) DNA and HBsAg are
undetectable in the blood for at least 6 months after stopping all treatment.
This indicates the disease is controlled by the immune system without
medication. 6  (#_edn6) A loss in HBsAg is also associated with an 89%
reduction in risk of liver cancer and a 62% reduction in risk of all-cause
mortality.(2) Notably, in an exploratory analysis, 49% of bepirovirsen
recipients achieved a quantitative hepatitis B surface antigen (qHBsAg) of
≤100 IU/mL one year after the end of treatment. Medical literature has
linked this level of low surface antigen with increased immune control and
improved patient outcomes. 7  (#_edn7) Moreover, 23% of all bepirovirsen
recipients (283 of 1220 vs 0 of 614 in the placebo group; p<0.001 in both
trials) and 31% of bepirovirsen recipients with baseline HBsAg ≤1000 IU/mL
(237 of 768 vs 0 of 393 in the placebo group; p<0.001 in both trials)
achieved a sustained HBV DNA lower limit of quantification (
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