There is new hope for the millions of people affected by chronic hepatitis B (CHB), a liver disease that can lead to cancer, scarring or organ failure and is responsible for more than a million deaths worldwide each year.
Following the results of two phase 3 clinical trials, published in the New England Journal of MedicineThe United States Food and Drug Administration (FDA) has approved the drug bepirovirsen for the treatment of CHB, under the brand name Hibsago.
GSK, the pharmaceutical company behind the drug’s development, describes bepirovirsen as the first “functional cure” for CHB, meaning it not only manages the virus that causes the infection – as existing treatments do – but suppresses it to undetectable levels in the blood.
Furthermore, in responding patients, the infection remains under control even after discontinuation of bepirovirsen treatment, again in contrast to the medications currently prescribed for CHB.
“This is the beginning of a new era in the treatment of people with CHB,” says gastroenterologist Norah Terrault of the University of Southern California Keck Medical Center.
“Bepirovirsen offers patients the opportunity to achieve a functional cure after a short period of treatment, a long-standing goal for both patients and physicians.
Results from the phase 3 trial showed that six months of treatment with bepirovirsen achieved functional recovery in 233 of 1,220 participants (19%), compared to 0 of 614 participants on a placebo drug.
In these patients, the virus remained undetectable for at least 24 weeks after stopping all treatment (72 weeks after the start of the trial).
The drug is given in weekly injections and was administered alongside existing pill treatments, which could then also be stopped for patients given the green light.
“For the first time, with Hibsago, U.S. patients have the potential to achieve a functional cure after six months of treatment, with the added convenience of the option of self-administration after the first dose,” said Tony Wood, chief scientific officer at GSK, the pharmaceutical company developing the drug.
In two trials, bepirovirsen was effective in 233 of 1,220 patients. (Hou et al., N.Engl. J.Med.2026)
Not everything is completely positive.
Some patients have experienced serious side effects, including liver inflammation, which the FDA says should be monitored through regular blood tests.
Traces of the virus also remain – whether the cure lasts for years after treatment ends remains to be proven.
However, the improvements in current treatments are marked enough that researchers are confident that a significant number of patients will benefit, and this is rubber-stamped by FDA approval.
“For many people living with chronic hepatitis B, treatment may mean taking antiviral medications for years to maintain suppression of the virus,” says Wendy Carter, acting director of the FDA’s Office of Infectious Diseases.
“Hibsago offers a new therapeutic approach that gives some patients the opportunity to maintain control of the virus after the end of any chronic HBV treatment. This approval represents an important advance for people living with this serious disease.”
Some CHB patients responded better to bepirovirsen than others. Lower levels of a key CHB protein at the start of treatment – indicating a less active infection – meant a greater chance of the new drug working. This is something that could be tested before bepirovirsen is prescribed.
The work doesn’t stop there.
Researchers want to see how the new treatment could be combined with other drugs to become even more effective, and GSK wants to make it available to more patients around the world.
“CHB poses a major public health challenge, affecting millions of people in the United States and accounting for approximately 56 percent of all liver cancer cases worldwide,” says Chari Cohen, president of the Hepatitis B Foundation.
“Today marks significant progress toward our goal of transforming the way CHB is managed with improvements in screening, diagnosis and the availability of innovative treatment options for our community. »
The results of the phase 3 clinical trials were published in the New England Journal of Medicine.
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