Nineteen percent of participants in clinical trials achieved a functional cure for chronic hepatitis B using the newly approved injection Hibsago (bepirovirsen), according to data from the U.S. Food and Drug Administration. The drug is the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B.
Approval for Chronic Hepatitis B Management
On October 20, 2026, the FDA authorized the use of Hibsago alongside current antiviral regimens for the treatment of chronic hepatitis B virus (HBV) infection in specific adult patients who do not have cirrhosis. Operating under the Department of Health and Human Services, the agency safeguards public health by ensuring the security, effectiveness, and safety of medical devices, as well as human and veterinary vaccines, drugs, and other biological products. Furthermore, to facilitate the clinical application of Hibsago, the FDA gave its approval to the Roche Elecsys HBsAg II quant II RxDx assay to serve as a companion diagnostic tool. This tool aids in the selection of appropriate patients for treatment and assists in monitoring them throughout the course of therapy.
Hibsago functions by targeting the genetic instructions the virus utilizes to replicate and produce viral proteins, which helps lower both the viral load and the presence of hepatitis B surface antigen in the body.
Clinical Trial Outcomes
In these studies, 233 of 1,220 participants treated with bepirovirsen achieved a functional cure response, defined as the virus remaining undetectable for at least 24 weeks after all treatment had concluded—or 72 weeks after the trial began. By contrast, none of the 614 participants in the placebo group achieved this result. Data from the B-Well study were also presented at The Liver Meeting 2026, held in Denver, Colorado, from November 5-9, 2026.
According to research presented at the meeting, functional cure rates varied based on baseline antigen levels. Modeling predicted mean functional cure rates of approximately 46% to 53% for patients receiving 24 weeks of bepirovirsen who had baseline HBsAg levels below 100 IU/mL.
Safety and Monitoring Requirements
According to the prescribing information, ALT and total bilirubin levels must be checked before treatment and frequently during the process. Treatment may require dose reductions, interruptions, or total cessation based on laboratory results. The label also carries warnings for worsening kidney function and serious inflammatory reactions such as vasculitis.
The drug is contraindicated in patients with a platelet count below 100 × 10⁹/L, and platelet counts should be monitored on a weekly basis during the treatment period. Norah Terrault, from the Keck Medical Center at the University of Southern California, noted that while ALT flares can occur as HBsAg levels decline and are generally well-tolerated, they necessitate close follow-up.
Future Considerations and Clinical Guidance
Experts are currently evaluating the transition in how this condition is managed. Terrault noted that future research is needed to determine if bepirovirsen could be paired with other agents in the HBV pipeline or if patients who do not reach a functional cure could benefit from a second course of treatment, as retreatment has not yet been studied.
Readers should consult with a qualified healthcare professional to determine if this treatment is appropriate for their specific medical history and condition.
Big news for people living with hepatitis B. 🧬 The FDA approved GSK’s Hibsago, a first-of-its-kind treatment that, alongside antiviral therapy, offers the potential for a functional cure of chronic hepatitis B. https://t.co/Yyd0XuS4LZ
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