Washington, Oct 2026 : The United States Food and Drug Administration (FDA) has approved a new treatment for chronic hepatitis B that could enable some patients to maintain control over the virus even after discontinuing all hepatitis B medication, marking a new development in the management of the long-term liver infection.
The FDA announced on Tuesday that it had approved Hibsago (bepirovirsen), an injectable medicine developed by British pharmaceutical company GSK, for certain adults with chronic hepatitis B who do not have cirrhosis. The treatment introduces a new approach to managing the infection and offers eligible patients the possibility of achieving sustained viral control without the need for continued antiviral therapy.
Hibsago is the first FDA-approved antisense oligonucleotide treatment for hepatitis B. This technology works by targeting specific genetic instructions involved in viral reproduction and the production of viral proteins, potentially helping the body's immune system control the infection.
"For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed," said Wendy Carter, acting director of the FDA's Office of Infectious Diseases.
"Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease," she added.
Eligibility restricted to specific patients
The approval covers adults with chronic hepatitis B who do not have cirrhosis and have already received antiviral treatment for at least six months. Their hepatitis B virus levels must be suppressed, and their hepatitis B surface antigen (HBsAg) levels must not exceed 3,000 international units per millilitre.
Eligibility is determined using an FDA-authorised companion diagnostic test developed by Roche, which helps identify patients who meet the required medical criteria.
The treatment is not intended to replace existing antiviral medicines immediately. Instead, it is administered alongside a patient's regular antiviral therapy, with discontinuation considered only after the treatment course and subsequent monitoring period.
Clinical trials demonstrate potential for treatment-free control
The FDA's approval was supported by findings from two clinical trials that compared Hibsago with a placebo. Participants received injections under the skin for up to 24 weeks while continuing their existing antiviral medication.
Following the final Hibsago injection, patients were required to remain on their regular antiviral treatment for at least another 24 weeks. Some participants were subsequently permitted to stop taking antiviral medicines if they met specified medical and laboratory criteria.
Across the two trials, 24 per cent of patients receiving Hibsago qualified to discontinue their existing antiviral medication, compared with none of those in the placebo groups.
More importantly, 24 weeks after stopping all hepatitis B treatment, 19 per cent of patients who had received Hibsago continued to demonstrate viral control, with hepatitis B surface antigen no longer detectable in their blood.
The findings suggest that the treatment could help a proportion of patients achieve sustained control of the infection without ongoing medication. However, the results also indicate that the majority of participants did not achieve this outcome, underlining the need for careful patient selection and continued medical supervision.
The approval does not mean that every patient receiving Hibsago will be able to discontinue antiviral therapy permanently. Treatment decisions will depend on individual responses and the ability to maintain control of the infection after medication is withdrawn.
FDA warns of serious safety risks
Despite the potential benefits, the FDA has highlighted significant safety concerns associated with Hibsago.
The medicine's prescribing information includes a boxed warning about serious liver reactions and reduced platelet counts. Low platelet levels can impair blood clotting and increase the risk of potentially life-threatening bleeding.
Additional warnings cover worsening kidney function, serious inflammatory reactions, including vasculitis, and complications associated with improper administration.
Patients receiving Hibsago will therefore require regular blood tests and medical assessments before and during treatment. Doctors will need to monitor liver function, platelet counts and other relevant indicators to identify potential complications and determine whether treatment should continue.
The most frequently reported side effects, apart from laboratory abnormalities, included reactions at the injection site, fever, fatigue and headache.
The FDA has also authorised Roche's companion diagnostic test to support patient selection and treatment monitoring, reinforcing the importance of identifying suitable candidates before initiating therapy.
Priority review reflects unmet medical need
Hibsago received Fast Track and Breakthrough Therapy designations, along with Priority Review from the FDA. These designations reflect the medicine's potential to address an important medical need and the agency's decision to expedite its regulatory assessment.
The approval has been granted to GSK plc. However, the FDA announcement did not specify when the medicine would become commercially available outside the United States, including in India.
Significance for hepatitis B patients
Chronic hepatitis B is a long-term viral infection that affects the liver and can lead to serious complications, including cirrhosis, liver failure and liver cancer. Although existing antiviral medicines can suppress viral replication and reduce the risk of disease progression, many patients require prolonged treatment.
The possibility of maintaining viral control after stopping medication could offer a different treatment pathway for eligible patients. Nevertheless, the clinical findings indicate that this outcome is limited to a proportion of those treated, and further experience will be important in understanding the medicine's long-term benefits and risks.
Hepatitis B remains a major public health concern across Asia, including India. Vaccination, early diagnosis, screening, access to antiviral medicines and regular medical monitoring remain essential to preventing complications and reducing the disease burden.
The US approval of Hibsago introduces another option in the treatment landscape, with the potential to reduce dependence on long-term antiviral medication for some patients. Its practical impact will depend on treatment response, safety monitoring, accessibility and future regulatory decisions in other countries.
(Disclaimer :The content of this article is sourced from a news agency and has not been edited by the Mavericknews30 team.)
