Preparing for Hepatitis B Functional Cure: Jordan Feld, MD, MPH

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The FDA’s recent approval of bepirovirsen (Hibsago; GSK), the first antisense oligonucleotide for chronic hepatitis B virus (HBV) infection, marks a step beyond lifelong viral suppression toward functional cure.¹

Reaching a functional cure matters because current therapy, although very effective, must be taken for a long time and, for many people, for life, Jordan Feld, MD, MPH, professor of medicine at the University of Toronto and section head of hepatology at University Health Network, said in an interview with The American Journal of Managed Care^® at IDWeek 2026, held October 21-24 in Washington, DC.

Functional cure lowers the risk of cirrhosis and liver cancer, even compared with long-term suppressive therapy, and lets patients come off all of their therapy, Feld said. Patients also lose the hepatitis B surface antigen (HBsAg) marker in their blood, which many find stigmatizing.

“In some countries, it can actually lead to people losing their jobs or having problems in their family,” he said. “So being surface antigen negative, which is really the definition of a functional cure, for many people is sort of giving them their freedom back to be living free of hep B instead of living with hep B with it controlled.”

Because some people clear HBV on their own, the search for a cure has focused on therapies that stimulate the immune system, Feld explained. Even antisense oligonucleotides, which directly target viral replication, appear to have an immunostimulatory effect that “might be the more important mechanism that’s driving functional cure,” he said.

To prepare, Feld said clinicians, patients, and payers should keep 2 points in mind. Patients will need to be restratified using quantitative HBsAg, which has not historically been measured routinely, and broader use of suppressive nucleos(t)ide analogue (NUC) therapy will be important, because most novel treatments are being studied in patients already on NUCs.

“Are you a good candidate for these new treatments, yes or no? And if you are, are you on a NUC? And if the answer is no, then we need to get you on a NUC first, suppress viral replication, and now you’re ready for that new therapy,” Feld said.

Bepirovirsen’s label also requires intensive monitoring, including platelet counts and renal function, and clinics will need the capacity “to be able to safely deliver these therapies,” he said.

References

1. McCormick B. Bepirovirsen approval offers new option for chronic HBV treatment. AJMC. October 21, 2026. Accessed October 23, 2026. https://www.ajmc.com/view/bepirovirsen-approval-offers-new-option-for-chronic-hbv-treatment