LONDON — An experimental hepatitis B therapy has shown the ability to produce a functional cure in a significant proportion of patients with chronic hepatitis B in late-stage clinical trials, according to results released by drugmaker GSK and published in a leading medical journal. The findings mark one of the most advanced developments in efforts to move beyond lifelong viral suppression treatments for the disease.
The therapy, bepirovirsen, is an investigational antisense oligonucleotide designed to target hepatitis B virus (HBV) genetic material and reduce viral activity. In two Phase 3 trials, known as B-Well 1 and B-Well 2, researchers evaluated the treatment in adults with chronic hepatitis B who were already receiving standard antiviral therapy.
According to pooled trial results reported by GSK, about 19% of participants receiving bepirovirsen achieved a functional cure compared with none in the control group. A functional cure was defined in the studies as sustained suppression of HBV DNA and loss of hepatitis B surface antigen after patients stopped treatment for a specified period.
The trials included more than 1,800 participants across multiple countries, according to GSK. The company said the treatment showed stronger responses among some patients with lower baseline viral activity, with a reported functional cure rate of about 26% in a subgroup with lower hepatitis B surface antigen levels.
Chronic hepatitis B affects hundreds of millions of people worldwide and remains a major cause of liver cirrhosis and liver cancer. Current antiviral medicines can suppress HBV replication but often require long-term or lifelong use and only rarely lead to loss of hepatitis B surface antigen, the key marker used in defining a functional cure.
The results were published in the New England Journal of Medicine and presented at the European Association for the Study of the Liver congress, according to the study publication and company announcements. Researchers noted that while the findings represent progress, additional monitoring will be needed to determine the durability of responses and how the treatment performs across broader patient populations.
GSK said it plans to pursue regulatory reviews for bepirovirsen following the Phase 3 results. The therapy remains investigational and is not yet approved for routine use.
The latest status of the program is pending regulatory decisions and further evaluation of long-term outcomes from the clinical trials.
