Bepirovirsen and the Push to Close Hepatitis B Care Gaps

World Hepatitis Day, observed July 28, arrives this year alongside new phase 3 data on bepirovirsen, an investigational antisense oligonucleotide positioned as a potential functional cure for chronic hepatitis B (CHB).¹

CHB affects more than 240 million people worldwide and accounts for over half of global liver cancer cases, underscoring the diagnostic and treatment gaps World Hepatitis Day is meant to spotlight.¹

GSK recently reported a pooled functional cure rate of 19% among bepirovirsen recipients across the B-Well 1 and B-Well 2 trials (233 of 1220 vs 0 of 614 with placebo; P <.001 in both trials).Results were presented at the European Association for the Study of the Liver congress and published in the New England Journal of Medicine on May 28, 2026. The rate rose to 26% among participants with baseline hepatitis B surface antigen levels of 1000 IU/mL or lower, a subgroup representing approximately 45% of diagnosed CHB cases globally.¹

The US Food and Drug Administration has granted the therapy Priority Review and Breakthrough Therapy designation, with a PDUFA target action date of October 26, 2026.¹

Despite that progress, most CHB cases in the United States remain undiagnosed, and most patients who are diagnosed and treatment-eligible are not receiving therapy. A new drug with a novel mechanism could drive renewed screening efforts. It also raises questions about where treatment will be delivered, since many patients, particularly within Asian communities, are managed in primary care rather than hepatology practices.

On a recent episode of Liver Lineup: Updates & Unfiltered Insights, Tatyana Kushner, MD, joined hosts Nancy Reau, MD, and Kimberly Brown, MD, to discuss how care delivery models may need to adapt to accommodate bepirovirsen. Together, they weighed primary care providers' existing experience managing complex hepatitis B populations against the added monitoring demands, including surveillance for ALT flares, that come with a new mechanism of action.

Q&A: Bepirovirsen and the Push to Close Hepatitis B Care Gaps

Kimberly Brown: Many patients with hepatitis B are not in our practices, right? They're in primary care practices, especially the Asian population. There are several primary care practitioners in the community that manage large groups of hepatitis B patients. Do you think that's an appropriate setting? That's where a lot of these patients are sitting, they're not really in hepatology practices always. What are we thinking about the uptake in those practices?

Tatyana Kushner: That's a really good point, and I think probably the first step will have to be to increase education and awareness that this treatment is on the horizon, and I do think that GSK, the company that makes bepirovirsen, are really thinking actively about how to do that and how to target their educational efforts. So the first step, I think, will be to make everyone aware that it's on the horizon. Then, in terms of where this treatment is administered, again, it will depend on how it looks in terms of monitoring, but to me it seems more that there will be some specialized centers that are able to take this on and treat with this medication.

Would it be a situation where those patients who are currently being followed in primary care actually have to be referred to a specialized center just to complete this treatment course, and then referred back to their primary care for ongoing treatment after? I'm just not convinced that with all the nuances with this treatment, that that will be able to be done in routine primary care settings, but I think we'll have to see.

Nancy Reau: I think that not all PCPs are the same. For a lot of our Asian patients, their hepatitis B is followed by a primary care provider that has a lot of expertise in hepatitis B, and our primary care doctors do hard things, right? They can give GLP-1s, which are injection therapy. They might be using cholesterol medicines that are alternative options. They might be giving bisphosphonates that are IV. I mean, there's lots of things that PCPs do that are inconvenient.

I think a primary care provider that has a large population of hepatitis B might really be excited about another drug, because it affects a majority of the patients. I think PCPs that have a handful of hepatitis B patients, where liver cancer surveillance, and even antiviral therapy may not be done the way that our guidance would suggest, those patients are probably going to have to be linked to a more specialized center.

I also think that just the approval of a new drug and a new mechanism of action will have an uptick in screening. One of the biggest issues in the US is the majority of hepatitis B patients are still not diagnosed, and of those that are diagnosed and appropriate for treatment, the majority are not on any treatment. So, hopefully, it'll shift a little more towards screening and standard of care.

Tatyana Kushner: Yeah, that is a really good point, and I think that it will depend on the care setting, and whether they have many patients who have hepatitis B, then why not take this on. But again, there’s the question of ALT flares. I mean, I'm scared when I see these high ALT elevations, how about a primary care doctor who is seeing all these hepatitis B carriers, or you know, patients that are relatively well controlled, who hasn't really dealt with ALT flares in this setting. I think it's those kinds of situations that may be a little bit distinct in a specialized setting versus primary care, but I agree that if they have a lot of hepatitis B experience, they may want to be able to be the ones that are offering this to their patients.

Editors’ note: Relevant disclosures for Reau include AbbVie, Gilead, Salix, Arbutus, and VIR. Relevant disclosures for Brown include Mallinckrodt Pharmaceuticals, Gilead, Salix, Intercept, Ipsen, and Madrigal. Relevant disclosures for Kushner include Gilead, Abbvie, GSK, Ipsen, Mirum, and Madrigal.

References

1. Brooks A. Bepirovirsen Achieves 19% Functional Cure in Chronic Hepatitis B. HCPLive. May 29, 2026. Accessed July 27, 2026. https://www.hcplive.com/view/bepirovirsen-achieves-19-functional-cure-in-chronic-hepatitis-b

2. US Centers for Disease Control and Prevention. About World Hepatitis Day. Accessed July 27, 2026. https://www.cdc.gov/hepatitis-awareness/about/world-hepatitis-day.html