FDA Approves Hibsago for Certain Adults With Chronic Hepatitis B
On October 20, 2026, the U.S. Food and Drug Administration approved Hibsago (bepirovirsen) injection for certain adults living with chronic hepatitis B virus infection who do not have cirrhosis. Manufactured by GSK plc, Hibsago is used together with existing antiviral drugs. It is the first antisense oligonucleotide approved by the agency for this condition. In clinical trials, 24% of patients receiving Hibsago alongside their regular medicine met the conditions to stop their existing treatment, compared to 0% of those receiving a placebo. Six months after stopping all therapy, 19% of Hibsago patients kept the virus under control with undetectable virus proteins in their blood. The drug carries a boxed warning for severe liver reactions and low platelet counts, which can raise the risk of dangerous bleeding. The agency also authorized a companion diagnostic test made by Roche to help select and monitor eligible patients.
What was announced
The U.S. Food and Drug Administration approved Hibsago (bepirovirsen) on October 20, 2026. The approval went to GSK plc. The injectable medicine works alongside existing oral antiviral treatments for adults with chronic hepatitis B who do not have cirrhosis. To qualify, patients must have taken antiviral therapy for at least six months, maintain suppressed virus levels, and show hepatitis B surface antigen levels at or below 3,000 IU/mL.
Alongside the drug, the FDA authorized the Roche Elecsys HBsAg II quant II RxDx assay. This diagnostic test helps healthcare providers identify suitable patients and monitor them during care. Hibsago is given under the skin for up to 24 weeks while continuing standard antiviral drugs.
What it means
Chronic hepatitis B is a long-lasting liver infection that can cause liver damage or liver cancer over time. Standard antiviral drugs often require lifelong daily use to keep the virus suppressed. Hibsago works differently by targeting the genetic instructions the virus uses to replicate and make proteins.
In two clinical trials, Hibsago allowed some patients to pause all hepatitis B drugs. About 24% of participants taking Hibsago met criteria to stop their regular medication, compared to none in the placebo group. Twenty-four weeks after stopping all treatments, 19% of Hibsago patients maintained control over the virus and had no detectable surface antigens in their blood.
Safety monitoring is necessary. The drug has a boxed warning for severe liver reactions and low platelet levels, which can lead to life-threatening bleeding. Other warnings include declining kidney function and systemic inflammation. Common side effects include fever, fatigue, headaches, and injection site reactions.
What the announcement does not tell us
The FDA announcement does not state the retail cost of Hibsago or whether insurance plans will cover it. It does not mention how long the viral control lasts beyond the 24-week post-treatment follow-up period in the trials. The release does not detail why the drug is restricted to patients without cirrhosis, nor does it provide a full breakdown of trial participant demographics.
How this was written
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FDA today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.
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