By VETTAPHARMA reporter – Derek Roche: GSK reported that bepirovirsen achieved what the company described as unprecedented functional cure rates in patients with chronic hepatitis B virus (HBV) infection, based on Phase IIb B-Clear trial results presented at the European Association for the Study of the Liver Congress 2026. Among participants receiving bepirovirsen in combination with standard-of-care nucleos(t)ide analog therapy, 27% achieved functional cure at Week 72, compared with 0% in the control group. Functional cure was defined as sustained hepatitis B surface antigen (HBsAg) loss and undetectable HBV DNA after completion of therapy.
The Phase IIb B-Clear study evaluated bepirovirsen, an antisense oligonucleotide designed to target HBV messenger RNA and reduce production of viral proteins including HBsAg. The trial enrolled patients with chronic hepatitis B receiving nucleos(t)ide analog treatment and assessed whether finite-duration therapy could achieve sustained viral control after treatment discontinuation.
GSK reported that 30% of patients receiving bepirovirsen achieved HBsAg loss at Week 72, while 31% achieved HBV DNA suppression below the lower limit of quantification. The company also noted that 35% of treated patients achieved both HBsAg loss and HBV DNA suppression during follow-up.
Chronic hepatitis B remains a major global health burden affecting approximately 254 million people worldwide, according to figures cited by GSK. Current antiviral therapies can suppress viral replication but rarely achieve functional cure, resulting in long-term treatment requirements for many patients.
The data position bepirovirsen among a growing group of next-generation HBV therapies attempting to move beyond viral suppression toward finite-duration treatment strategies. Achieving functional cure has become a major objective across the hepatitis B development landscape as companies seek differentiated approaches capable of reducing lifelong treatment dependence.
From a patient perspective, durable HBsAg loss could potentially reduce long-term disease progression risks and decrease the need for continuous antiviral therapy. For GSK, positive functional cure data may strengthen its position in the competitive hepatitis B market, where multiple developers are pursuing curative treatment approaches targeting different stages of the viral lifecycle.
Quick FAQs
1. What is bepirovirsen?
Bepirovirsen is an investigational antisense oligonucleotide designed to reduce hepatitis B viral protein production.
2. What were the key B-Clear trial results?
GSK reported that 27% of treated patients achieved functional cure at Week 72 compared with 0% in the control group.
3. What is the study/trial?
The Phase IIb B-Clear study evaluated bepirovirsen plus standard nucleos(t)ide analog therapy in patients with chronic hepatitis B.
4. What is the disease condition?
Chronic hepatitis B is a viral liver infection that can lead to cirrhosis, liver failure, and hepatocellular carcinoma.
5. Why is functional cure important in hepatitis B?
Functional cure aims to achieve sustained HBsAg loss and viral suppression, potentially reducing lifelong treatment requirements.
6. What could the data mean for GSK?
Positive functional cure outcomes may strengthen GSK’s competitive position in the emerging hepatitis B curative treatment market.
