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The FDA approved Hibsago (bepirovirsen), an antisense oligonucleotide, with existing antiviral therapy for certain adults with chronic hepatitis B who do not have cirrhosis. In two trials, 19% of Hibsago recipients maintained viral control with undetectable hepatitis B surface antigen 24 weeks after stopping all treatment; serious safety risks require monitoring.
The U.S. Food and Drug Administration on October 20, 2026, approved Hibsago (bepirovirsen) with existing antiviral therapy for certain adults with chronic hepatitis B who do not have cirrhosis. The agency described it as the first FDA-approved antisense oligonucleotide for the infection; trial results indicate that some eligible patients may maintain viral control after all hepatitis B treatment ends.
The approval covers adults without cirrhosis who have taken hepatitis B antiviral therapy for at least six months, have suppressed levels of the virus in their blood, and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, measured using an FDA-authorized test. HBsAg is a protein associated with hepatitis B infection. Hibsago is given as an injection under the skin for up to 24 weeks, alongside a patient’s existing antiviral medicine.
Patients continue their existing medicine for at least 24 weeks after their last Hibsago injection. Some may then be able to stop the antiviral, but only if they meet specified health and laboratory requirements. In two placebo-controlled trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none of those who received placebo. Across the Hibsago group, 19% had controlled virus and undetectable HBsAg 24 weeks after stopping all hepatitis B treatment, according to the FDA release.
The FDA also authorized Roche’s Elecsys HBsAg II quant II RxDx assay as a companion diagnostic. The test is intended to help identify eligible patients and support monitoring during treatment. The agency granted Hibsago Fast Track and Breakthrough Therapy designations and Priority Review before approving it; the approval was granted to GSK plc.
Chronic hepatitis B treatment often involves taking antiviral medicine for years to keep the virus suppressed. Hibsago adds a treatment approach intended to reduce viral material and HBsAg, with the possibility that some eligible patients could later stop all therapy while maintaining control. The trial findings suggest that this outcome is possible for a subset, not that most patients can discontinue treatment: 19% of Hibsago recipients met the reported outcome 24 weeks after stopping all treatment.
The distinction matters for patients and clinicians weighing treatment options. Approval does not mean that Hibsago replaces existing antivirals or that every person who receives it can stop them. The treatment is approved as an add-on for a narrowly defined adult population, and decisions to stop the existing medicine depend on health and laboratory checks. The results also describe a specific follow-up point—24 weeks after treatment cessation—rather than establishing how durable control will be over longer periods.
Safety monitoring is a substantial part of the decision. The FDA issued a boxed warning for serious liver reactions and low platelet counts, which can raise the risk of potentially life-threatening bleeding. The label also warns of worsening kidney function, serious inflammatory reactions such as vasculitis, and risks linked to improper injection. Regular blood tests and clinician follow-up are required to monitor for these problems.
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How Hibsago Fits Existing Care
Chronic hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. The FDA says it can lead over time to serious liver disease, including cirrhosis, and increase the risk of liver cancer. Existing antiviral medicines can suppress the virus, but many people continue taking them for years.
Hibsago is an antisense oligonucleotide. According to the FDA, it targets the genetic instructions the virus uses to make copies of itself and viral proteins, helping reduce the amount of virus and HBsAg in the body. The approved regimen pairs it with existing antiviral therapy rather than using it alone at the outset. Its study pathway therefore includes injections, continued antiviral use afterward, and assessment before any treatment is stopped.
The FDA’s release reports results from two trials comparing Hibsago with placebo, but does not provide details such as the number of participants, demographic breakdowns, or longer-term follow-up in the announcement. The agency says the companion assay will aid patient selection and monitoring in line with the drug’s approved labeling.
“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed.”
— Wendy Carter, DO, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research
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Long-Term Control and Patient Eligibility
The FDA announcement does not say how many trial participants were studied, how the results varied across patient groups, or whether viral control persisted beyond the reported 24-week follow-up after all treatment stopped. Longer-term durability and the proportion of patients who may qualify in routine care are not established by the information in the release.
It is also not clear from the announcement how many patients experienced serious adverse reactions or how risks differed among participants. The approved population excludes people with cirrhosis and requires prior antiviral use, suppressed virus levels, and an HBsAg result within the specified range. Clinicians and patients will need to follow the full prescribing information and monitoring requirements; the FDA’s trial percentages should not be read as a prediction for any individual.
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Monitoring After FDA Approval
Clinicians can use the FDA-authorized companion assay and the drug’s labeling to assess eligibility and monitor patients during treatment. People receiving Hibsago need regular blood tests and follow-up before and during therapy to check for liver reactions, low platelet counts, kidney changes, and inflammatory complications.
After up to 24 weeks of injections, patients are to continue their existing antiviral medicine for at least another 24 weeks. Only those who meet the required health and laboratory criteria may be considered for stopping that medicine. Further information about longer-term outcomes, safety in broader practice, and how reliably viral control persists after treatment ends will depend on additional follow-up and use of the therapy.
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Key Questions
Who is eligible for Hibsago under the FDA approval?
It is approved for certain adults without cirrhosis who have taken hepatitis B antiviral therapy for at least six months, have suppressed virus levels, and have HBsAg levels of 3,000 IU/mL or less measured by an FDA-authorized test.
Does Hibsago replace a patient’s existing hepatitis B medicine?
No. Hibsago is used with existing antiviral therapy. Patients continue that medicine for at least 24 weeks after their final Hibsago injection. Some may later stop it if they meet specified health and laboratory requirements.
How many patients maintained control after stopping all treatment?
In the FDA-reported trials, 19% of patients who received Hibsago had controlled virus and undetectable HBsAg 24 weeks after stopping all hepatitis B treatment. The release does not establish how long control may last beyond that follow-up point.
What safety risks did the FDA identify?
Hibsago carries a boxed warning for serious liver reactions and low platelet counts, which can increase bleeding risk. The FDA also lists warnings for worsening kidney function, serious inflammatory reactions such as vasculitis, and risks from improper injection. Regular testing and clinician follow-up are required.
Source: primary
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