Washington, October 21, 2026 (Yes Punjab News)
The United States has approved a new treatment for chronic hepatitis B that could allow some patients to stop taking antiviral medicines while maintaining control over the virus.
The US Food and Drug Administration (FDA) announced on Tuesday that it had approved Hibsago (bepirovirsen), an injectable medicine developed by GSK, for certain adults with chronic hepatitis B who do not have cirrhosis.
The treatment is the first FDA-approved antisense oligonucleotide for hepatitis B. It uses technology designed to interfere with the genetic instructions that enable the virus to reproduce and produce viral proteins.
Wendy Carter, acting director of the FDA’s Office of Infectious Diseases, said many people with chronic hepatitis B need to take antiviral medicines for years to keep the virus suppressed.
She said Hibsago offers some eligible patients the possibility of maintaining control of the virus after completing all hepatitis B treatment, describing the approval as an important advance for people living with the disease.
The approval covers adults without cirrhosis who have received antiviral therapy for at least six months and have suppressed levels of hepatitis B virus in their blood. Patients must also have hepatitis B surface antigen levels of 3,000 international units per millilitre or less, confirmed through an FDA-authorised diagnostic test.
The medicine was evaluated in two clinical trials comparing Hibsago with a placebo. Participants received injections under the skin for up to 24 weeks while continuing their existing antiviral medicines. They then continued their regular treatment for at least another 24 weeks after the final injection. Some participants were subsequently allowed to stop antiviral therapy if they met specified medical and laboratory criteria.
Across the two trials, 24 per cent of patients receiving Hibsago qualified to stop their existing antiviral medication, compared with none in the placebo groups. Twenty-four weeks after stopping all hepatitis B treatment, 19 per cent of Hibsago recipients maintained viral control, with hepatitis B surface antigen no longer detectable in their blood.
The results suggest that some patients may maintain control without continued treatment, although most participants did not achieve this outcome.
The FDA warned that Hibsago carries significant safety risks. Its prescribing information includes a boxed warning for serious liver reactions and reduced platelet counts, which can increase the risk of potentially life-threatening bleeding. Other warnings include worsening kidney function, serious inflammatory reactions such as vasculitis, and complications associated with improper administration.
Patients will require regular blood tests and medical monitoring before and during treatment. Commonly reported side effects, apart from laboratory abnormalities, included injection-site reactions, fever, fatigue and headache.
The FDA also authorised a companion diagnostic test developed by Roche to help identify eligible patients and monitor treatment.
Hibsago received Fast Track and Breakthrough Therapy designations, along with Priority Review. The approval was granted to GSK plc. The FDA announcement did not specify when the treatment would become commercially available outside the United States, including in India.
Chronic hepatitis B is a long-term viral infection affecting the liver and can lead to serious complications, including cirrhosis and liver cancer. Prevention through vaccination, screening and access to treatment remains important in controlling the disease, particularly in Asia, including India.
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