FDA Approves Hepatitis B Shot That May Let Some Patients Stop All Treatment

Key TakeawaysA newly approved hepatitis B shot may let some adults stop all treatment and still control the virusIn trials, about 1 in 5 patients kept the virus in check six months after stopping medicationThe drug carries a serious warning for liver reactions and bleeding risk, so regular blood tests are required.FRIDAY, Oct. 23, 2026 (HealthDay News) — Some adults with chronic hepatitis B may now have a path to something today’s treatments rarely deliver — stopping all medication while the virus stays in check.The U.S. Food and Drug Administration on Tuesday approved Hibsago (bepirovirsen) for certain adults with the long-term liver infection. It’s the first drug of its kind for hepatitis B. It works differently from existing antiviral pills by disrupting the genetic messages the virus needs to multiply.Over time, chronic hepatitis B can scar the liver, a condition called cirrhosis, and raise the risk of liver cancer. About 1.7 million people in the United States have the infection, according to GSK, the drug’s maker.Standard antiviral treatment means a daily pill, typically for more than a year, according to the Hepatitis B Foundation.“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” Dr. Wendy Carter, acting director of the FDA’s Office of Infectious Diseases, said in a news release.Hibsago isn’t for everyone. It’s approved for adults without cirrhosis who’ve been on antiviral medicine for at least six months, whose virus is suppressed and who have low levels of a viral protein called hepatitis B surface antigen. Patients get Hibsago as a shot under the skin for up to six months, along with their usual medicine. After the first dose, they can choose to give themselves the injections, GSK said.Once they’ve been off the shots for six months, those who meet certain health and lab requirements may be able to stop their regular medicine.In two clinical trials, 24% of patients given Hibsago met those requirements, the FDA said. None of those given a placebo (an inactive treatment) did.Six months after stopping all hepatitis B treatment, 19% of patients who got Hibsago were still keeping the virus in check. The viral protein also wasn’t detectable in their blood.GSK calls this result a “functional cure,” meaning the immune system controls the infection without medicine.Dr. Norah Terrault, chief of gastroenterology and hepatology at USC’s Keck Medical Center in Los Angeles, called the approval “the start of a new era.” Reaching a functional cure after a short course of treatment is “a long-standing goal for patients and physicians alike,” she said in a GSK news release.The drug carries serious risks. Its label includes a boxed warning, the FDA’s strongest, for severe liver reactions and for low levels of platelets (blood cells that help stop bleeding), which can lead to life-threatening bleeding. Patients need frequent blood work before and during treatment.The Hepatitis B Foundation notes that there’s still no complete cure for hepatitis B. It advises regular checkups with a liver specialist, usually every six months, whether or not people are being treated.More informationVisit the Cleveland Clinic for more information about hepatitis B treatment.SOURCES: U.S. Food and Drug Administration, Oct. 20, 2026; GSK, company announcement, Oct. 20, 2026 .What This Means For YouIf you have chronic hepatitis B and have taken antiviral pills for a while, ask your liver specialist whether this new shot might be right for you. .Sign up for our weekly HealthDay newsletter

FDA Approves Hepatitis B Shot That May Let Some Patients Stop All Treatment

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