In the quiet arithmetic of a long illness, a new drug has offered something chronic hepatitis B has rarely allowed: the possibility of stopping treatment and staying well. Researchers presenting at The Liver Meeting in Denver reported that most patients who reached a functional cure with bepirovirsen remained cured for nearly a year after their medicine and their daily antiviral pills ended. The finding is hopeful, but it belongs to a minority of those treated, and the wider world of the approximately 1.7 million Americans living with the virus is still learning what it means to be cured rathe
Bepirovirsen's Hepatitis B Functional Cure Holds for About 9 in 10 Responders 48 Weeks Off Therapy
Roughly 9 of 10 responders kept a functional cure off all treatment
Mark
Ninety to ninety-two percent staying cured sounds remarkable. What's the headline here?
Mimi
That people who responded kept responding. Off all hepatitis B treatment for 48 weeks, 114 of 127 in B-Well 1 and 97 of 105 in B-Well 2 held their functional cure.
Luke
But that's a subset. Only 19% to 20% of treated patients reached functional cure at week 72, and no placebo patients did.
Mimi
Right, and the durability group was narrowed further to those who stopped NAs and completed week 96.
Mark
Why does stopping therapy matter so much?
Mimi
Standard NA therapy is typically taken indefinitely. Finite treatment with a lasting result is a different model of care.
Luke
One patient relapsed and restarted NAs. Small number, but it shows relapse isn't zero.
Mark
What about patients with very low surface antigen?
Mimi
The trials didn't enroll them. GSK modeled 46% to 53% cure rates for that group, with a lower bound of 34%.
Luke
And that's a prediction made by the manufacturer, not trial data. I'd hold it loosely until real-world results exist.
Mark
And the care pathway?
Mimi
Eight steps, 100% panel consensus, with priorities like quantitative HBsAg testing and care coordinators.
Luke
Consensus on a pathway is agreement on how to deliver care, not proof it improves outcomes.
Il Polso
- Only about one in five treated patients reached functional cure by week 72, while no placebo patient did, so the promise is real but narrow.
- Roughly 90 to 92 percent of those cured held their response 48 weeks after stopping all hepatitis B therapy, a result that unsettles the decades-long assumption of indefinite treatment.
- The FDA's October 2026 approval opened a new pathway, yet it is limited to adults without cirrhosis, suppressed on nucleos(t)ide analogues, with HBsAg at or below 3000 IU/mL.
- Patients with the lowest surface antigen levels remain outside the trial data, and their hopeful cure rates rest on a manufacturer's model rather than observed outcomes.
- A US care pathway built by clinicians, pharmacists, and advocates is being shaped around quantitative HBsAg testing, access, and adherence, as the field tests whether finite therapy can move from trial to clinic.
In the quiet arithmetic of a long illness, a new drug has offered something chronic hepatitis B has rarely allowed: the possibility of stopping treatment and staying well. Researchers presenting at The Liver Meeting in Denver reported that most patients who reached a functional cure with bepirovirsen remained cured for nearly a year after their medicine and their daily antiviral pills ended. The finding is hopeful, but it belongs to a minority of those treated, and the wider world of the approximately 1.7 million Americans living with the virus is still learning what it means to be cured rather than merely held in check.
At The Liver Meeting 2026 in Denver, researchers reported that a hepatitis B functional cure produced by bepirovirsen, sold by GSK as Hibsago, held in about nine of ten responders for 48 weeks after all hepatitis B treatment had stopped. The results come from the end-of-study analysis of the phase 3 B-Well 1 and B-Well 2 trials, and they arrive just weeks after the FDA approved the drug on October 20, 2026, as the first antisense oligonucleotide for chronic hepatitis B.
The approval is narrow. It applies to adults without cirrhosis who have taken a nucleos(t)ide analogue for at least six months, have suppressed virus, and have surface antigen levels at or below 3000 IU/mL. Standard therapy controls the virus but is usually taken indefinitely, so the idea of a finite course that ends in cure is a significant shift for the roughly 1.7 million Americans living with the infection.
In the trials, patients were randomized two to one to bepirovirsen or placebo weekly for 24 weeks, and eligible patients stopped their antivirals at week 48. By week 72, about 20 percent of treated patients in each trial had reached functional cure, and no placebo patient had. Among those who stopped treatment, held that cure, and completed follow-up, 90 and 92 percent kept their durable response. Safety in the later weeks looked quiet, with no evidence of latent problems. One patient relapsed and resumed antiviral therapy.
A second analysis turned to the patients the trials left out, those with very low surface antigen levels. Using model-based projections built by GSK, investigators estimated cure rates of roughly 46 to 53 percent for this group. These are predictions, not observed results, and the field is watching closely to see whether they hold outside the manufacturer's model.
Finally, a poster described a US care pathway for finite therapy, shaped by a multidisciplinary panel through two consensus meetings. Its priorities include quantitative antigen testing, access to treatment, adherence support, provider education, care coordination, and community awareness. The authors suggest it could help guide a shift from lifelong suppression toward a cure, though the next chapter depends on real-world results.
At The Liver Meeting 2026 in Denver, researchers reported that a hepatitis B functional cure produced by the drug bepirovirsen (Hibsago, made by GSK) held in roughly 9 of 10 responders 48 weeks after they stopped all hepatitis B treatment. The figures come from the end-of-study analysis of the phase 3 B-Well 1 and B-Well 2 trials.
The timing matters. The FDA approved bepirovirsen on October 20, 2026, the first antisense oligonucleotide cleared for chronic HBV infection. It is approved for use alongside nucleos(t)ide analogue (NA) therapy in adults without cirrhosis who have taken an NA for at least 6 months, have suppressed HBV DNA, and have hepatitis B surface antigen (HBsAg) levels of 3000 IU/mL or less on an FDA-authorized test. GSK says about 1.7 million people in the United States live with chronic HBV. Standard NA therapy suppresses the virus but is typically taken indefinitely.
In the B-Well trials, functional cure meant at least 24 weeks of sustained undetectable HBV DNA plus loss of HBsAg after finite therapy. Both trials were global and double-blind, enrolling adults without cirrhosis whose virus was suppressed on NAs and whose HBsAg sat above 100 and at or below 3000 IU/mL. Patients were randomized 2:1 to bepirovirsen 300 mg or placebo weekly for 24 weeks, and eligible patients stopped their NAs at week 48. The primary outcome was functional cure at week 72. Those pivotal results were earlier presented at the European Association for the Study of the Liver Congress 2026 and published in the New England Journal of Medicine.
At week 72, 20% of bepirovirsen patients in B-Well 1 (127 of 650) and 19% in B-Well 2 (106 of 570) had reached functional cure. No placebo patient did. So the durability finding applies to a minority of those treated. About 24% of bepirovirsen patients entered the durability stage after week 72. Among those who stopped NAs, had functional cure at week 72, and completed week 96, 90% (114 of 127) in B-Well 1 and 92% (97 of 105) in B-Well 2 had a durable response. Similar durability appeared in those with baseline HBsAg of 1000 IU/mL or less. One patient who stopped NAs had a viral relapse and restarted NA therapy after week 72.
Safety in weeks 73 to 96 looked quiet. The most common adverse events were upper respiratory tract infection (4%), decreased creatinine renal clearance (2%), and nasopharyngitis (2%). Treatment-related adverse events occurred in 2% of patients, all single events. The investigators described an acceptable safety profile with no evidence of latent safety concerns from prior bepirovirsen treatment.
A second presentation addressed patients the trials left out: those with HBsAg below 100 IU/mL. GSK investigators used model-based extrapolation from 1194 B-Well participants, benchmarked against 2067 patients in the real-world Everest study of pegylated interferon. Within B-Well, functional cure rose as baseline HBsAg fell, reaching 40% in the 100 to 200 IU/mL subgroup. The model predicted mean cure rates of about 46% to 53% after 24 weeks in NA-treated patients below 100 IU/mL, with the lower bound of the 95% CI suggesting at least 34%. These are model predictions, not trial results, and GSK produced them.
A third presentation, a poster, laid out a US care pathway for finite therapy. A multidisciplinary panel of clinicians, pharmacists, and advocates used a nominal group technique across two 2026 consensus meetings to adapt a 9-step global pathway proposed in 2025. The first meeting, mainly nonspecialists, produced six steps; the second, mainly specialists, expanded it to eight, each with 100% consensus. The final version separates shared decision-making at the start and end of treatment and adds detail to monitoring. Panelists named quantitative HBsAg testing, access to treatment, patient engagement and adherence tools, provider education, care coordinators, and community awareness as implementation priorities.
The authors wrote that the pathway may help guide a shift from chronic viral suppression to finite functional cure therapy. What to watch next: real-world results in treated patients, and whether the low-HBsAg predictions hold up outside a manufacturer's model.
Citazioni salienti
The new 8-step US FC pathway and implementation priorities may help guide the paradigm shift in CHB management from chronic viral suppression to finite FC therapy.— Authors of the US care pathway poster, The Liver Meeting 2026
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