GSK's Bepirovirsen Shows 19% Functional Cure in Hepatitis B Trials
GSK reported that its bepirovirsen achieved a 19% functional cure rate in adults with chronic hepatitis B during phase 3 trials, significantly outperforming standard care. The results were announced on September 11, 2026, with regulatory reviews pending.
GSK has announced significant results from its pooled phase 3 B-Well 1 and B-Well 2 trials, showing that its experimental drug, bepirovirsen, achieved a 19% functional cure rate in adults suffering from chronic hepatitis B. This outcome is defined as having undetectable levels of HBV DNA and HBsAg for at least 24 weeks post-treatment. The results highlight the potential of bepirovirsen as a promising therapeutic option compared to the standard of care, which reported a 0% functional cure rate. The phase 3 trials took place across 29 countries, reflecting a comprehensive international effort to evaluate the efficacy of bepirovirsen. They met their primary endpoints, indicating that the drug is on track to potentially reshape treatment protocols for chronic hepatitis B.
The announcement of these results on September 11, 2026, marks a pivotal moment in the ongoing battle against hepatitis B, a disease affecting millions globally. Bepirovirsen is categorized as an antisense oligonucleotide, a class of drugs designed to specifically target and inhibit viral replication at the genetic level. This innovative approach is part of a broader trend in hepatitis B research, which increasingly seeks to provide targeted therapies that can lead to functional cures rather than just viral suppression. The drug's mechanism may offer new hope to those living with chronic hepatitis B.
GSK's successful trial results have caught the attention of regulatory bodies, prompting the FDA to grant both Priority Review and Breakthrough Therapy designation for bepirovirsen. The Prescription Drug User Fee Act (PDUFA) date for this promising treatment is set for October 26, 2026. This expedited review process underscores the urgency and potential impact of the drug in the public health landscape. Looking ahead, GSK plans to continue its work on bepirovirsen with the aim of bringing it to market as a viable treatment option for chronic hepatitis B. The promising results from the phase 3 trials could pave the way for further studies and the exploration of combination therapies.
The significance of this drug extends beyond individual patient outcomes, as it represents a potential shift in the management of hepatitis B on a global scale, addressing a critical health issue that affects millions worldwide.
Enjoyed this story?
Show the newsroom a little love — one tap per reader.
Priya reports on breakthroughs that change lives, big and small.
Be part of the good
Stories like this start with people who care. Share it, or submit your own uplifting story to inspire millions today.
