A new medicine developed by pharmaceutical company GSK has received approval in the United States, offering some adults living with chronic hepatitis B the possibility of controlling the infection without remaining on treatment indefinitely.
The US Food and Drug Administration (FDA) approved Hibsago (bepirovirsen) on October 20, 2026, for certain adults with chronic hepatitis B whose infection is already suppressed by existing antiviral medicines and who meet specific clinical criteria.
The medicine is an antisense oligonucleotide designed to target genetic material involved in the production of hepatitis B virus proteins. This mechanism could help the immune system control the infection more effectively than conventional antiviral treatment alone.
Chronic hepatitis B affects the liver and can lead to cirrhosis, liver failure and liver cancer. Although existing antiviral medicines can suppress the virus, many patients require long-term treatment to maintain control of the infection.
What the Clinical Trials Found
According to the FDA, clinical trial results showed that 24 per cent of patients treated with bepirovirsen met the criteria for stopping their existing hepatitis B medication, compared with none in the placebo group.
The results also showed that 19 per cent of treated patients maintained control of the infection 24 weeks after stopping all hepatitis B treatment. These patients had no detectable hepatitis B surface antigen, a marker associated with the virus.
This outcome is known as a functional cure. It does not mean that the virus has necessarily been completely eliminated from the body, but that the infection can remain under control without continued treatment in some patients.
Under the approved regimen, Hibsago is administered by injection for up to 24 weeks alongside existing antiviral therapy. Patients must continue their existing medicine for at least another 24 weeks after their final injection, and any decision to stop treatment depends on meeting specified clinical and laboratory criteria.
The medicine also carries important safety risks, including potentially serious liver reactions and reduced platelet counts, which can increase the risk of bleeding. Patients require medical supervision and regular blood tests throughout treatment.
The approval marks a development in the search for treatments that can achieve sustained control of chronic hepatitis B. However, the results do not guarantee a functional cure for every patient, and the medicine is not suitable for all people living with the infection.
The US approval also does not automatically authorize the medicine for use in Nigeria. Further regulatory steps would be required before it could be marketed locally.
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