The US Food and Drug Administration (FDA) has approved Hibsago, a hepatitis B treatment offering new hope to patients seeking long-term control of the chronic viral infection without continuous antiviral therapy.
The drug, whose generic name is bepirovirsen, is the first antisense oligonucleotide approved by the FDA for chronic hepatitis B.
Developed by British pharmaceutical company GSK, it works by reducing the production of viral RNA and proteins, lowering hepatitis B surface antigen (HBsAg) levels in the blood and potentially helping the immune system achieve a lasting response.
Clinical trial results showed that nearly 20% of patients treated with bepirovirsen achieved undetectable viral levels and remained off antiviral medication for at least 6 months.
The findings came from the B-Well 1 and B-Well 2 trials, which were randomised, double-blind, placebo-controlled studies conducted across multiple centres in 29 countries.
Chronic hepatitis B develops when the immune system fails to eliminate the virus, leaving patients with a long-term infection that can cause serious liver damage. More than 240 million people worldwide are affected by the disease, which is associated with approximately 1.1 million deaths annually and remains a leading cause of liver cancer.
Current standard treatments enable only about 1%-4% of patients to achieve sustained viral clearance, commonly referred to as a functional cure.
Hibsago has also received regulatory approval in Japan, while applications for its approval are under review in China and Europe.