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FDA approves Hibsago, a new kind of treatment for chronic hepatitis B
In brief
The U.S. Food and Drug Administration on Tuesday, October 20, 2026, approved Hibsago (bepirovirsen), an injection made by GSK, for certain adults with chronic hepatitis B. It is the first FDA-approved antisense oligonucleotide for the disease, and the agency says it may let some patients keep the virus under control after stopping all hepatitis B treatment.
Who it is approved for
Hibsago is approved for use together with existing antiviral medicine in adults without cirrhosis who have taken hepatitis B antivirals 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 on an FDA-authorized test. The FDA also authorized a Roche test as a companion diagnostic to help pick suitable patients and monitor treatment.
The medicine works by targeting the genetic instructions the virus uses to copy itself and make its proteins. It is injected under the skin for up to 24 weeks, and patients keep taking their usual medicine for at least 24 weeks after the last dose.
What the trials found
In two placebo-controlled trials, 24% of patients given Hibsago met the requirements to stop their existing medicine, compared with none on placebo. Twenty-four weeks after stopping all hepatitis B treatment, 19% of patients who received Hibsago still had the virus under control with no detectable HBsAg. The drug carries a boxed warning for serious liver reactions and low platelet counts, plus warnings about kidney function and inflammatory reactions, so patients need regular blood tests. The FDA said the most common side effects were injection site reactions, fever, tiredness and headache.
Chronic hepatitis B is a long-term liver infection that can lead to cirrhosis and raises the risk of liver cancer. Many people take antiviral pills for years, so a treatment that might allow some to stop is a notable change.
VSH take: the key word here is some: about one in five trial patients stayed in control after stopping treatment, and only certain patients qualify. Anyone living with hepatitis B should talk to their own doctor before changing anything. If you are tracking a long treatment plan, our date difference calculator counts the weeks between doses or check-ups, and the guide on counting days between two dates explains how.
This is our own summary of an FDA announcement, for general information only, not medical advice. ViralScopeHub is not affiliated with the FDA or GSK.
Why it matters
Chronic hepatitis B usually means years of daily medicine; this is the first approved option designed to let some patients stop treatment and stay in control of the virus.
People also ask
What is Hibsago?
Hibsago (bepirovirsen) is an injection by GSK, approved by the FDA on October 20, 2026, as the first antisense oligonucleotide treatment for chronic hepatitis B.
Who can take Hibsago?
Certain adults without cirrhosis who have taken hepatitis B antivirals for at least six months, have suppressed virus levels and HBsAg of 3,000 IU/mL or less, as decided by their doctor.
How well did Hibsago work in trials?
24% of patients met the criteria to stop their usual medicine, versus none on placebo, and 19% kept the virus under control 24 weeks after stopping all treatment.
Related free tools: Date Difference Calculator
Sources
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