FDA approves first functional cure for chronic hepatitis B, offering hope to millions

Hibsago (bepirovirsen) can control the virus after treatment ends, reducing need for lifelong medication

By LineZotpaper

Published22 October 2026

Read Time3 min

The US Food and Drug Administration has approved Hibsago (bepirovirsen), the first treatment that offers a functional cure for chronic hepatitis B, a disease affecting more than 250 million people worldwide and causing upwards of a million deaths each year. Clinical trials showed that 19% of patients achieved undetectable virus levels 24 weeks after stopping all therapy, compared with less than 1% under standard care.

The approval marks a significant advance for patients who have long relied on daily antiviral medication to suppress the hepatitis B virus (HBV). Chronic hepatitis B is a leading cause of cirrhosis and liver cancer, accounting for an estimated 56% of liver cancers globally.

Hibsago, developed by GSK, is delivered by injection and is intended for adults free of cirrhosis who have been on certain antiviral therapies for at least six months. The FDA granted the drug Priority Review and Breakthrough Therapy Designation based on its improvement over existing treatment.

"For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed," said Dr. Wendy Carter, Acting Director of the Office of Infectious Diseases at the FDA's Center for Drug Evaluation and Research. "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."

Functional cure means HBV DNA and a viral protein called HBsAg remain undetected for 24 weeks after all treatment is stopped, indicating that the immune system has the disease under control without ongoing intervention. It is not a complete cure, but a major step forward.

Across two phase III B-Well trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none who received placebo. Of those, 19% maintained viral control after 24 weeks off all treatment.

"Despite current therapies, many people living with chronic hepatitis B remain on treatment indefinitely and continue to face the risk of serious liver complications," said Tony Wood, GSK's Chief Scientific Officer. "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."

Dr. Norah Terrault, Chief of Gastroenterology & Hepatology at USC Keck Medical Center, called the approval "the start of a new era" and said bepirovirsen "offers patients the potential to achieve functional cure after a short period of treatment, a long-standing goal for patients and physicians alike."

While an effective vaccine against hepatitis B exists, vaccine hesitancy and inadequate access in some regions have allowed the disease to persist. Poor screening and misinformation about transmission, particularly perinatal transfer, have also hampered prevention efforts.

Analysis

Why This Matters

For the first time, a subset of chronic hepatitis B patients may stop all antiviral treatment and still keep the virus under control, potentially reducing the lifelong pill burden and risk of liver complications.
The 19% functional cure rate, though modest, is a dramatic leap from the less than 1% rate with standard care and could translate into millions of lives saved or improved given the global disease burden.
The approval may accelerate research into combination therapies or earlier intervention to raise the cure rate further.

Background

Chronic hepatitis B is a viral infection that attacks the liver and can lead to cirrhosis and hepatocellular carcinoma. It is transmitted through blood and bodily fluids, most commonly from mother to child at birth. While antiviral drugs can suppress the virus, they rarely eliminate it, and patients typically require lifelong treatment. Functional cure, defined as sustained undetectable virus after stopping therapy, has been an elusive goal. GSK's bepirovirsen is an antisense oligonucleotide that targets viral RNA, marking a novel mechanism against the disease.

Key Perspectives

[Patients and advocates]: For those living with chronic hepatitis B, the option to stop daily medication and achieve viral control represents a transformative improvement in quality of life, provided they meet the eligibility criteria. [Physicians and hepatologists]: The approval opens a new treatment paradigm, but careful patient selection is crucial because only those without cirrhosis and with low baseline HBsAg levels appear to benefit. Expanding access and monitoring for long-term durability will be key. [Public health officials]: While the new therapy is a breakthrough, it does not replace the need for vaccination and screening. Preventing new infections and diagnosing existing cases early remain essential to reducing the global burden.

What to Watch

Uptake among eligible patients and real-world effectiveness data as post-marketing studies track long-term durability of functional cure.
Pricing and insurance coverage decisions, which will determine access in the US and influence global availability.
Development of next-generation therapies or combinations that might raise the 19% cure rate to a majority of patients.

Sources

Breakthrough hepatitis B drug offers 'functional cure' for first time · New Atlas: Technology-Innovation-Outdoor News

Checked

12 claims in this story checked against 1 source: 7 supported.

Show each claim

Partly supportedThe FDA approved the first functional cure for chronic hepatitis B.New Atlas: Technology-Innovation-Outdoor News: “For the first time, many people living with chronic hepatitis B may have a functional cure at hand.”
SupportedHibsago can maintain control of the virus after treatment ends, potentially avoiding ongoing medication.New Atlas: Technology-Innovation-Outdoor News: “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.”
Partly supportedNineteen per cent achieved undetectable virus levels 24 weeks after stopping all therapy, compared with less than 1% under standard care.New Atlas: Technology-Innovation-Outdoor News: “Results from the B-Well phase III trials demonstrated "functional cure" rates of 19% in adults with ≤3000 IU/ml HBsAg, compared to current standard of care alone, which is less than 1% after 12 months.”
SupportedThe disease affects more than 250 million people worldwide and causes upwards of a million deaths each year.New Atlas: Technology-Innovation-Outdoor News: “affecting more than 250 million people worldwide and causing upwards of a million deaths each year.”
SupportedTwenty-four per cent of Hibsago recipients met the requirements to stop their existing medicine, compared with none on placebo.New Atlas: Technology-Innovation-Outdoor News: “Across the two trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none who received placebo.”
Partly supportedOf the patients who met the requirements to stop existing medicine, 19% maintained viral control after 24 weeks off all treatment.New Atlas: Technology-Innovation-Outdoor News: “Across the two trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none who received placebo. Twenty-four weeks after stopping all hepatitis B treatment, 19% of patients who received Hibsago still had the virus under control”
Partly supportedPatients have long relied on daily antiviral medication to suppress HBV.New Atlas: Technology-Innovation-Outdoor News: “Until recently, many of those with the condition have had no choice but to rely on long-term use of antiviral medication to keep CHB's viral load at bay.”
SupportedChronic hepatitis B accounts for an estimated 56% of liver cancers globally.New Atlas: Technology-Innovation-Outdoor News: “CHB is reportedly the cause of an estimated 56% of liver cancers worldwide.”
SupportedThe FDA granted Priority Review and Breakthrough Therapy Designation because of improvement over existing treatment.New Atlas: Technology-Innovation-Outdoor News: “According to the FDA, the approval of bepirovirsen was granted under the organization's Priority Review and Breakthrough Therapy Designation category, due to its significant improvement "over existing standard of care."”
SupportedWendy Carter said Hibsago gives some patients the possibility of maintaining control after all chronic HBV treatment has ended.New Atlas: Technology-Innovation-Outdoor News: ““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.””
Partly supportedNorah Terrault called the approval “the start of a new era.”New Atlas: Technology-Innovation-Outdoor News: ““This is the start of a new era in treating people living with CHB,” says Dr. Norah Terrault”
SupportedVaccine hesitancy and inadequate access have contributed to hepatitis B’s ongoing prevalence, while poor screening and misinformation have hampered prevention efforts.New Atlas: Technology-Innovation-Outdoor News: “hesitancy towards it has grown , and other regions have inadequate access to such preventative medicines, resulting in the ongoing prevalence of hepatitis B. What's more, poor screening has hampered interventions ... while efforts to block its major transmission route – perinatal transfer – have been complicated by myths and misinformation”