Hepatitis B – BiotechReality – Information Intelligence System for Biopharma

GSK plc (LSE/NYSE: GSK) today announced positive results from its pivotal Phase III clinical trial program for bepirovirsen. This investigational treatment could redefine the standard of care for millions living with chronic hepatitis B (CHB). The results from two massive global studies, B-Well 1 and B-Well 2, demonstrated that bepirovirsen achieved a statistically significant and clinically meaningful "functional cure" rate, offering hope for a finite treatment window for a disease that currently requires lifelong medication for most patients. A New Frontier in Hepatitis Treatment Chronic hepatitis B is a silent epidemic affecting over 250 million people worldwide. It remains the leading cause of liver cancer, accounting for approximately 56% of cases globally. While current nucleos(t)ide analogue (NA) therapies can suppress the virus, they rarely eliminate it; the functional cure rate with existing standards of care sits at a dismal 1%. GSK’s bepirovirsen aims to change that. As a first-in-class antisense oligonucleotide (ASO), the drug employs a "triple action" strategy: it inhibits viral replication, suppresses the hepatitis B surface antigen (HBsAg) in the blood, and stimulates the patient’s own immune system to regain control over the infection. Trial Results: Meeting the Primary Endpoint The B-Well program involved over 1,800 participants across 29 countries. The trials were designed to evaluate the efficacy of bepirovirsen in patients already receiving standard antiviral therapy. Key findings from the announcement include: Functional Cure Achieved: The trials met their primary endpoint, with significantly higher functional cure rates defined as the sustained loss of HBsAg and undetectable HBV DNA for 24 weeks after completing treatment compared to those receiving standard care alone. Optimal Patient Profiles: While results were significant across the board, patients with lower baseline surface antigen levels (≤1000 IU/ml) showed an even greater response to the therapy. Safety Profile: The treatment demonstrated an acceptable safety and tolerability profile, consistent with earlier Phase II data. Read More: GSK’s Blenrep Gets U.S. FDA Approval for Multiple Myeloma Treatment Looking Ahead: Regulatory Filings and Global Impact With these positive results in hand, GSK confirmed plans to begin global regulatory filings as early as the first quarter of 2026. If approved, bepirovirsen would become the first finite, six-month therapeutic option for CHB. Medical experts suggest that a functional cure is the "holy grail" of hepatitis B treatment. By clearing the surface antigen and allowing the immune system to manage the virus without daily pills, patients significantly reduce their risk of long-term liver complications, including cirrhosis and liver cancer. GSK also intends to explore bepirovirsen as a "backbone" therapy, potentially combining it with other experimental agents to further increase cure rates in broader patient populations. The full data set from the B-Well 1 and B-Well 2 trials is expected to be presented at an upcoming major scientific congress and published in a peer-reviewed medical journal later this year. Information: GSK Last Modified:

Tag: Hepatitis B

GSK Announces Breakthrough Phase III Results for Bepirovirsen, Signaling Potential “Functional Cure” for Chronic Hepatitis B

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