US FDA Approves Hibsago as New Treatment for Chronic Hepatitis B

The US Food and Drug Administration has approved Hibsago as a new treatment for certain adults with chronic hepatitis B. The approval was announced on October 20, 2026. The medicine is given as an injection alongside existing antiviral drugs for eligible patients who do not have advanced liver scarring or cirrhosis.

How It Works

Hibsago is the first approved antisense oligonucleotide for this infection. It works by targeting the genetic instructions that the hepatitis B virus uses to make copies of itself and produce viral proteins. This helps lower the amount of the virus and surface antigen in the body. In clinical trials, twenty-four percent of patients who received Hibsago met the requirements to stop their existing medicines, compared with zero in the placebo group. Twenty-four weeks after stopping all treatment, 19 percent of patients who got Hibsago still kept the virus under control and had no detectable surface antigen in their blood.

Patient Eligibility And Risks

Dr Ameet Mandot, Director of Hepatology at Gleneagles Hospital in Parel, notes that the drug offers some patients a functional cure where the infection stays under control without ongoing medication. Not all patients qualify for the therapy. Patients must have taken antiviral medicines for at least six months, have suppressed virus levels, and show hepatitis B surface antigen levels of 3,000 IU/mL or less through an approved test. The treatment also carries risks. Common side effects include fever, fatigue, headache, and injection site reactions. Serious warnings involve liver reactions, low platelet counts, worsening kidney function, and vasculitis, which causes blood vessel inflammation.

Context

Chronic hepatitis B is a long-term liver infection that can lead to severe liver disease and raise the risk of liver cancer over time. Most patients require years of daily antiviral medicines to keep the virus suppressed rather than clearing it entirely. Regular medical supervision and blood tests remain essential for anyone undergoing new drug therapies to manage potential health complications safely.