This is the start of a new era in treating people living with CHB,
said gastroenterologist Norah Terrault of the Keck Medical Center at the University of Southern California. The U.S. Food and Drug Administration approved Hibsago (bepirovirsen) on October 20, 2026, for certain adults with chronic hepatitis B, and Health Canada followed on November 3.
The FDA’s announcement describes Hibsago as the first approved antisense oligonucleotide for the infection. It is given in combination with existing antiviral therapy to adults without cirrhosis, and GSK plc holds the approval.
Who Qualifies for Hibsago and How the Course Works
According to the FDA’s approval notice, eligible patients have taken hepatitis B antiviral therapy for at least six months, have suppressed virus in the blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as measured by an FDA-authorized test. The agency also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic.
Hibsago is injected under the skin for up to 24 weeks. Patients keep taking their usual medicine for at least 24 weeks after the last injection. Some may then stop it if they meet health and lab requirements.
Trials Show 19% Functional Cure, Against None on Placebo
According to the FDA, in two placebo-controlled trials, 19% of Hibsago recipients kept the virus under control, with no detectable HBsAg, a protein that signals hepatitis B infection, in their blood 24 weeks after all treatment ended.
ScienceAlert’s account gives the raw counts: 233 of 1,220 participants responded, against 0 of 614 on placebo. The Canadian release adds that the rate was 26% in adults with baseline HBsAg of 1,000 IU/mL or less, again against 0% on placebo. Lower starting levels of the protein meant better odds of success, ScienceAlert noted.
🧬 A NEW HEPATITIS B DRUG HAS ACHIEVED SOMETHING MEDICINE HAS BEEN CHASING FOR DECADES. For millions of people living with chronic hepatitis B, controlling the virus can mean taking medication for years, sometimes for life. But a newly FDA-approved treatment could change that… pic.twitter.com/5S7GLowrCc
Regulators, Clinicians and Advocates Weigh In
Wendy Carter, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, framed the change in terms of time on medication.
For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,
Wendy Carter, FDA Center for Drug Evaluation and Research
In Canada, GSK’s announcement quoted Dr. Michelle Horn, the company’s country medical director, who said a functional cure through a finite course changes expectations from lifelong management to the prospect of stopping treatment
. Jennifer Nebesky, CEO of Liver Canada, said the diagnosis brings years of worry and can still carry stigma. The release estimates 262,000 people in Canada live with the disease.
Boxed Warning Demands Close Monitoring
The enthusiasm comes with caveats. A boxed warning on Hibsago covers serious liver reactions and also low platelet counts, which may raise the risk of potentially life-threatening bleeding. The most common side effects are injection site reactions, fever, fatigue and headache.
Terrault, speaking to HCPLive, said ALT flares may occur as HBsAg declines and are generally well tolerated but need close follow-up. Patients on stable antiviral therapy are often tested only every six months, she noted. She urged clinicians to begin measuring HBsAg periodically and to discuss functional cure and its monitoring commitment with patients. Her disclosures include GSK.
According to ScienceAlert, traces of the virus stay in the body. How long the effect lasts over many years is not established.
Liver Meeting Data Test Durability and an 8-Step Pathway
Findings presented at The Liver Meeting 2026 in Denver (November 5-9) and summarized by Europesays point to follow-up beyond week 72. From weeks 73 to 96, the most common adverse events were upper respiratory tract infection (4%), decreased creatinine renal clearance (2%) and nasopharyngitis (2%). The investigators said bepirovirsen had an acceptable safety profile without any evidence of latent safety concerns associated with prior [bepirovirsen] treatment.
Because the trials did not enroll patients with HBsAg below 100 IU/mL, GSK investigators modeled that group, predicting mean functional cure rates of approximately 46% to 53%. The report stresses these are model predictions made by the manufacturer, not trial results.
A separate U.S. expert panel adapted a global care pathway into 8 steps. Its authors wrote that the new 8-step US FC pathway and implementation priorities may help guide the paradigm shift in CHB management from chronic viral suppression to finite FC therapy
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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
Among the open questions, Terrault said, are combining bepirovirsen with other agents in the pipeline and whether patients who fall short of functional cure but end treatment with lower HBsAg levels might benefit from a second course. Retreatment has not yet been studied, she said.
More on Hibsago
The FDA has cleared GSK’s Hibsago (bepirovirsen), delivering the first 24-week functional cure regimen for chronic hepatitis B. The biology is a triumph, but the label exposes the commercial friction: – Indication gated strictly to baseline HBsAg < 3,000 IU/ml via authorized…
🚨#FDA Approval Update | A new approach to chronic hepatitis B treatment The FDA has approved #Hibsago (#bepirovirsen), the first antisense oligonucleotide approved for chronic hepatitis B virus (HBV) infection. 🔸Used alongside existing antiviral therapy, Hibsago targets HBV… pic.twitter.com/s4DXWsfKqq
FDA APPROVES HIBSAGO (BEPIROVIRSEN) FOR CHRONIC HEPATITIS B IN ADULTS WITHOUT CIRRHOSIS $GSK pic.twitter.com/pj080OqG3X