Plate Nº 15 · recorded November 5, 2026
Health & Medicine ResearchReported finding
FDA Approves First 'Functional Cure' Drug for Chronic Hepatitis B
FDA approval of GSK's bepirovirsen (Hibsago) gives chronic hepatitis B patients a first functional cure: virus undetectable in 19% of trial patients, sustained after treatment stopped.
By Elena Vasquez3 min read634 words
In brief
- FDA approved bepirovirsen (Hibsago), the first functional cure drug for chronic hepatitis B
- 19 percent of treated patients (233 of 1,220) achieved functional cure vs 0 of 614 on placebo
- Virus stayed undetectable at least 24 weeks after treatment stopped
- CHB causes over a million deaths per year and about 56 percent of global liver cancer cases
- Serious side effects included liver inflammation, requiring monitoring via blood tests
The FDA has approved bepirovirsen, brand name Hibsago, as the first drug offering a "functional cure" for chronic hepatitis B. In phase 3 trials, 233 of 1,220 patients who received the drug — 19 percent — reached that functional cure. Zero of 614 placebo patients did.
The trial results appear in the New England Journal of Medicine. GSK developed the drug and markets it.
Chronic hepatitis B, or CHB, is a liver infection that can lead to cancer, scarring, or organ failure. It kills more than a million people worldwide each year. Chari Cohen, President of the Hepatitis B Foundation, notes CHB accounts for roughly 56 percent of all global liver cancer cases.
What makes this a 'functional cure'?
Existing CHB treatments only manage the virus. Patients take antiviral pills daily, often for years, to keep it suppressed. Stop the pills, and the virus comes back.
Bepirovirsen works differently. In patients who respond, it suppresses the virus to undetectable levels in the blood — and those levels hold even after treatment ends. That's the "functional cure": the virus traces remain in the body, but the infection stays under control without ongoing medication.
In the trials, the virus stayed undetectable for at least 24 weeks after all treatment stopped, which was 72 weeks after the trial began.
"This is the start of a new era in treating people living with CHB," says Norah Terrault, a gastroenterologist at the Keck Medical Center at the University of Southern California. "Bepirovirsen offers patients the potential to achieve functional cure after a short period of treatment, a long-standing goal for patients and physicians alike."
How is the drug given?
Treatment runs six months, delivered through weekly injections alongside existing pill treatments. Patients given the all-clear could then stop those pills too.
Tony Wood, GSK's Chief Scientific Officer, highlighted the practical side. "For the first time, with Hibsago, US patients have the potential to achieve functional cure after a six-month treatment course, with the added convenience of the option of self-administration after the first dose," he said.
Who benefits most?
Not everyone responds, and doctors can already predict who will. Patients with lower levels of a key CHB protein at the start of treatment — a marker of a less active infection — had a higher chance of the drug working. That protein could be tested before prescribing.
Wendy Carter, Acting Director of the FDA's Office of Infectious Diseases, framed the approval as a change in approach. "For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed," she said. "Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended."
What are the limitations?
The results aren't uniformly rosy. Some patients experienced serious side effects, including liver inflammation. The FDA says regular blood tests should monitor for that risk.
The durability question also remains open. Traces of the virus persist in the body, and no one has yet proven the cure holds for years after treatment ends. The 24-week post-treatment window is encouraging but short.
Even so, the improvement over current options convinced both the researchers and the regulator. The FDA's approval is the rubber stamp.
What comes next?
Researchers plan to test bepirovirsen in combination with other drugs to boost its effectiveness. GSK says it wants to expand access to more patients worldwide.
"Today marks significant progress towards our aim of transforming the way CHB is managed with improvements in screening, diagnosis, and the availability of innovative treatment options for our community," Cohen said.
A 19 percent cure rate may sound modest. For a disease that has forced millions into lifelong daily medication, it's a first.
via doi.org (Original)
More from Elena Vasquez
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Correspondent covering money, funding and market shifts around general science news at SciBeat.
295 articles
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