Bepirovirsen Shows Durable Functional Cure Rates in Chronic Hepatitis B Trials

Bepirovirsen maintains functional cure rates through week 96 in hepatitis B trials

Patients treated with bepirovirsen for chronic hepatitis B achieved a durable functional cure through 96 weeks of follow-up, according to results presented at The Liver Meeting 2026 in Denver. The data, reported by HCPLive, shows that for those who successfully reached a functional cure and subsequently stopped nucleos(t)ide analogues (NAs), the response remained remarkably stable.

The implications for chronic hepatitis B (CHB) management are significant. For decades, the standard of care has largely focused on long-term viral suppression rather than elimination. These new findings suggest a potential shift toward finite, curative therapies. In the B-Well 1 and B-Well 2 trials, the pooled rate of durable functional cure among responders who stopped NAs and completed week 96 was 91%.

Baseline HBsAg levels dictate success rates

While the overall durability is high, the effectiveness of bepirovirsen appears heavily influenced by a patient’s initial viral load, specifically the hepatitis B surface antigen (HBsAg) levels. A post hoc pooled analysis revealed that functional cure rates declined as baseline HBsAg levels increased. For instance, among participants with baseline HBsAg below 200 IU/mL, the cure rates were 40% at week 72 and 35% at week 96. However, for those starting with levels between 2500 and 3000 IU/mL, the rate dropped to 4% at both timepoints.

The American Journal of Managed Care noted that for patients with baseline HBsAg below 100 IU/mL, GSK, the drug’s manufacturer, produced a model predicting mean functional cure rates of approximately 46% to 53% after 24 weeks of bepirovirsen treatment. It is worth noting that these specific low-HBsAg estimates are model predictions rather than direct trial results.

The following table summarizes the functional cure rates based on baseline HBsAg levels as reported in the study:

Baseline HBsAg Level	Week 72 Cure Rate	Week 96 Cure Rate
Below 200 IU/mL	40%	35%
200 to < 300 IU/mL	31%	30%
500 to < 1000 IU/mL	16%	15%
2500 to 3000 IU/mL	4%	4%

Beyond the strict definition of functional cure, the drug showed broad impact on viral markers. At week 72, 49% of bepirovirsen recipients either achieved a functional cure or reached a quantitative HBsAg of 100 IU/mL or less. By week 96, 97% of those with available data had HBsAg levels at or below 100 IU/mL.

Safety profiles and the new clinical care pathway

As the medical community weighs these results, the focus is shifting toward how to integrate this therapy into standard practice. A multidisciplinary panel of US clinicians, pharmacists, and advocates recently worked to adapt a global care pathway into a new 8-step US clinical care pathway. According to The American Journal of Managed Care, this pathway aims to transition CHB management from chronic suppression to finite functional cure therapy. Key priorities for this implementation include quantitative HBsAg testing, patient engagement, and provider education.

Hepatitis B Functional Cure Persists Off Treatment After Bepirovirsen — Photo: The American Journal of Managed Care

Safety data from the durability stage remains encouraging. Between weeks 73 and 96, the most frequent adverse events were upper respiratory tract infections (4%), decreased creatinine renal clearance (2%), and nasopharyngitis (2%). Treatment-related adverse events occurring after the cessation of bepirovirsen were rare, affecting only 2% of participants as single events.

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“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,” the authors of the consensus meeting concluded.

The clinical utility of the drug will likely depend on precise patient selection. In an interview with HCPLive, Norah Terrault, MD, MPH, a B-Well coauthor, emphasized that quantitative HBsAg testing will be central to identifying which patients are the best candidates for this treatment approach.

While the data presents a clear path forward for a specific subset of patients, the economic and logistical challenge remains: ensuring widespread access to the necessary diagnostic testing and the therapy itself to realize these curative potential outcomes across the broader patient population.