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The FDA approved Hibsago (bepirovirsen), an antisense oligonucleotide, for certain adults with chronic hepatitis B who do not have cirrhosis and meet specific treatment and blood-test criteria. In two trials, 19% of Hibsago recipients still had the virus under control and 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 FDA says some eligible patients may be able to maintain viral control after stopping all hepatitis B treatment, but the trial results show that outcome is not assured and the drug carries serious safety warnings.
Hibsago is an antisense oligonucleotide that targets genetic instructions the hepatitis B virus uses to make copies of itself and viral proteins. The FDA describes this as a new treatment approach and says Hibsago is the first FDA-approved antisense oligonucleotide for chronic hepatitis B. Its approval is limited to certain adults without cirrhosis who have taken antiviral therapy for at least six months, have suppressed virus levels in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, measured with an FDA-authorized test.
The FDA said two clinical trials compared Hibsago with a placebo. Patients received injections under the skin for up to 24 weeks, while continuing their existing hepatitis B medicine for at least another 24 weeks after the final injection. Patients may then stop that medicine only if they meet specified health and laboratory requirements. Across the trials, 24% of Hibsago recipients met the requirements to stop their existing medicine, compared with none of those who received placebo.
Among patients who received Hibsago, 19% still had the virus under control and no detectable HBsAg in their blood 24 weeks after stopping all hepatitis B treatment, according to the FDA. That result describes a subset of trial participants, not a guaranteed outcome for patients prescribed the drug. The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic to help select patients and monitor them during treatment in line with the drug’s labeling.
A Possible Pause in Long-Term Therapy
Chronic hepatitis B often requires long-term antiviral treatment to keep the virus suppressed. The FDA says Hibsago may give some carefully selected patients a chance to stop all treatment while maintaining control, addressing a significant burden for people who otherwise may take antiviral medication for years. The trial findings, however, indicate that only a portion of treated participants reached the criteria to stop their existing medicine, and fewer maintained the reported response after all treatment ended.
The approval also adds a new type of therapy to the available approach for chronic HBV and ties its use to a specific diagnostic test. For patients and clinicians, the practical question is not simply whether Hibsago is approved, but whether an individual meets the eligibility criteria and can be monitored safely. The data reported in the FDA release do not establish that every eligible patient will be able to discontinue therapy or that viral control will persist beyond the reported follow-up.
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Eligibility and Treatment Sequence
The FDA describes chronic hepatitis B as a long-term liver infection that can lead over time to serious liver disease, including cirrhosis, and increase the risk of liver cancer. Hibsago’s approval applies to adults without cirrhosis who have already been on antiviral therapy for at least six months, have suppressed HBV in their blood, and meet the stated HBsAg threshold using an authorized test. It is not described as a stand-alone replacement for existing antiviral medicine at the start of treatment.
The treatment sequence matters: Hibsago is given alongside the patient’s existing medicine, which continues for at least 24 weeks after the last injection. Only after that period may a clinician consider stopping the existing medicine, and only when health and laboratory requirements are met. The FDA granted Fast Track and Breakthrough Therapy designations and Priority Review before approving the drug. The approval was granted to GSK plc.
“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.”
— Wendy Carter, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research
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Safety and Durability Questions
The FDA release reports outcomes 24 weeks after patients stopped all hepatitis B treatment; it does not state how long viral control may last beyond that follow-up or what proportion of all patients who begin Hibsago will ultimately be able to stop treatment. The release also does not provide detailed trial participant numbers or additional outcome breakdowns, so the reported percentages should not be read as a prediction for an individual patient.
Safety is a major consideration. Hibsago carries a boxed warning for serious liver reactions and low platelet counts, which can raise the risk of potentially life-threatening bleeding. FDA warnings also include worsening kidney function, serious inflammatory reactions such as vasculitis, and serious risks if the injection is not administered properly. Patients need regular blood tests and follow-up with a healthcare provider before and during treatment. The most common side effects, excluding laboratory abnormalities, were injection-site reactions, fever, fatigue and headache.
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Patient Selection and Follow-Up
Clinicians will need to determine whether a patient meets the FDA’s no-cirrhosis, treatment-history, viral-suppression and HBsAg criteria, using the authorized companion diagnostic as directed by the drug labeling. For people who start Hibsago, treatment involves injections for up to 24 weeks alongside existing antiviral medication, followed by at least 24 weeks continuing that medication after the last injection.
Any decision to stop the existing antiviral medicine depends on meeting the specified health and laboratory requirements, with continued clinical monitoring. The FDA calls for regular blood tests and provider follow-up to watch for liver, platelet, kidney and inflammatory risks. The agency’s announcement does not provide a broader schedule for future evidence or longer-term trial results; patients should discuss the treatment’s risks and suitability with their healthcare provider.
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Key Questions
Who may be eligible for Hibsago?
The FDA approved it for certain adults with chronic hepatitis B who do not have cirrhosis, have taken HBV antiviral therapy for at least six months, have suppressed virus levels in their blood and have HBsAg levels of 3,000 IU/mL or less as measured by an FDA-authorized test.
Does Hibsago replace existing hepatitis B medicine immediately?
No. Patients take Hibsago alongside their existing antiviral medicine. They continue that medicine for at least 24 weeks after the last Hibsago injection; stopping it may be considered only if specified health and laboratory requirements are met.
How many patients maintained control after stopping all treatment?
Across two trials, the FDA reported that 19% of Hibsago recipients had virus control and undetectable HBsAg 24 weeks after stopping all hepatitis B treatment. This is a trial result for that follow-up period, not a guarantee for an individual patient or evidence of longer-term durability.
What serious risks does the FDA warn about?
Hibsago has a boxed warning for serious liver reactions and low platelet counts, which can increase bleeding risk. Other warnings include worsening kidney function, serious inflammatory reactions such as vasculitis, and risks from improper injection. The FDA says regular blood tests and healthcare-provider follow-up are needed.
Source: primary
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