Nisha Pandey

Health and Me

US FDA Approves First-Of-Its-Kind Hepatitis B Drug That Helped 19% Patients Stay Off Treatment For Six Months

The <span>US Food and Drug Administration</span> (<span>FDA</span>) has approved <span>Hibsago</span> (bepirovirsen), a first-of-its kind treatment for certain adults with chronic hepatitis B. The drug controlled virus activity in some patients after stopping all treatment.

Announced on October 20, 2026, the approval makes Hibsago the first FDA-approved antisense oligonucleotide for chronic hepatitis B. 

It is approved for certain adults without cirrhosis who have already been taking antiviral medication for at least six months, have suppressed levels of hepatitis B virus (HBV) and meet specific criteria for hepatitis B surface antigen (HBsAg).

In clinical trials, 19% of patients receiving Hibsago maintained viral control 24 weeks after stopping all <a href="https://www.healthandme.com/health-news/hepatitis-b-infections-could-rise-83-if-us-changes-newborn-vaccine-policy-study-article-156375523" data-type="tilCustomLink">hepatitis B</a> treatment. No amount of HBsAg was detected in their blood. The treatment is meant to offer an alternative for some patients who otherwise need long-term antiviral medication.

“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, DO, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

“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.”

Hibsago targets the genetic aspects the hepatitis B virus targets. By reducing viral RNA and hepatitis B surface antigen, the drug helps the immune system control the infection even after after treatment ends.

The drug is administered as an injection under the skin for up to 24 weeks, alongside a patient's existing hepatitis B medication. Patients continue their treatment for at least 24 weeks after the final Hibsago injection. They can then stop all treatment if they meet specified clinical and laboratory criteria.

The FDA also authorised a diagnostic test to help identify eligible patients and monitor them during treatment.

Also read: <a href="https://www.healthandme.com/health-news/g155e-h1n1-mutation-in-us-raises-concerns-can-this-years-flu-shot-still-protect-you-article-156374682" data-type="tilCustomLink">G155E H1N1 Mutation In US Raises Concerns: Can This Year’s Flu Shot Still Protect You?</a>

<h2>What Did The Clinical Trials Find?</h2>

The approval was supported by two Phase 3 trials, B-Well 1 and B-Well 2, which compared Hibsago with a placebo in adults receiving established antiviral treatment.

Across the trials, 24% of patients receiving Hibsago met the criteria to stop their existing antiviral medication, compared to none in the placebo groups.

At 24 weeks after stopping all treatment, 19% of patients receiving Hibsago maintained viral control. Hepatitis B surface antigen was also no longer detectable in their blood.

The outcome means the virus remains controlled without ongoing treatment according to specified laboratory criteria.

Also read: <a href="https://www.healthandme.com/health-news/h-pylori-hpv-among-five-infections-behind-1-in-8-cancers-worldwide-lancet-article-156245302" data-type="tilCustomLink">H. pylori, HPV Among Five Infections Behind 1 In 8 Cancers Worldwide: Lancet</a>

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Hibsago carries a warning for serious liver reactions and thrombocytopenia, or low platelet counts, which can increase the risk of life-threatening bleeding.

Other warnings include poor <a href="https://www.healthandme.com/health-wellness/are-people-with-ckd-at-higher-risk-of-dementia-and-cognitive-problems-article-156251954" data-type="tilCustomLink">kidney</a> function and inflammatory reactions like vasculitis. Patients require regular blood tests and medical monitoring before and during treatment.

The FDA granted Hibsago Fast Track and Breakthrough Therapy designations, along with Priority Review. The drug was approved for GSK plc.

The treatment is not suitable for everyone with chronic hepatitis B. Eligibility depends on liver health, existing treatment, viral suppression and laboratory results.

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The US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen), a first-of-its kind treatment for certain adults with chronic hepatitis B. The drug controlled virus activity in some patients after stopping all treatment.Announced on October 20, 2026, the approval makes Hibsago the first FDA-approved antisense oligonucleotide for chronic hepatitis B. It is approved for certain adults without cirrhosis who have already been taking antiviral medication for at least six months, have suppressed levels of hepatitis B virus (HBV) and meet specific criteria for hepatitis B surface antigen (HBsAg).In clinical trials, 19% of patients receiving Hibsago maintained viral control 24 weeks after stopping all hepatitis B treatment. No amount of HBsAg was detected in their blood. The treatment is meant to offer an alternative for some patients who otherwise need long-term antiviral medication.“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, DO, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.“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.”How Does Hibsago Work?Hibsago targets the genetic aspects the hepatitis B virus targets. By reducing viral RNA and hepatitis B surface antigen, the drug helps the immune system control the infection even after after treatment ends.The drug is administered as an injection under the skin for up to 24 weeks, alongside a patient's existing hepatitis B medication. Patients continue their treatment for at least 24 weeks after the final Hibsago injection. They can then stop all treatment if they meet specified clinical and laboratory criteria.The FDA also authorised a diagnostic test to help identify eligible patients and monitor them during treatment.Also read: G155E H1N1 Mutation In US Raises Concerns: Can This Year’s Flu Shot Still Protect You?What Did The Clinical Trials Find?The approval was supported by two Phase 3 trials, B-Well 1 and B-Well 2, which compared Hibsago with a placebo in adults receiving established antiviral treatment.Across the trials, 24% of patients receiving Hibsago met the criteria to stop their existing antiviral medication, compared to none in the placebo groups.At 24 weeks after stopping all treatment, 19% of patients receiving Hibsago maintained viral control. Hepatitis B surface antigen was also no longer detectable in their blood.The outcome means the virus remains controlled without ongoing treatment according to specified laboratory criteria.Also read: H. pylori, HPV Among Five Infections Behind 1 In 8 Cancers Worldwide: LancetWhat Are The Risks?         Hibsago carries a warning for serious liver reactions and thrombocytopenia, or low platelet counts, which can increase the risk of life-threatening bleeding.Other warnings include poor kidney function and inflammatory reactions like vasculitis. Patients require regular blood tests and medical monitoring before and during treatment.The FDA granted Hibsago Fast Track and Breakthrough Therapy designations, along with Priority Review. The drug was approved for GSK plc.The treatment is not suitable for everyone with chronic hepatitis B. Eligibility depends on liver health, existing treatment, viral suppression and laboratory results.

us fda approves first-of-its-kind hepatitis b drug that helped 19% patients stay off treatment for six months

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US FDA Approves First-Of-Its-Kind Hepatitis B Drug That Helped 19% Patients Stay Off Treatment For Six Months

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