---
title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: References"
description: "Reference list for the formulary evidence report on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis. 190 cited documents."
canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references"
published: "2026-10-21T22:39:04-04:00"
modified: "2026-10-22T19:07:03-04:00"
---

# Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: References

<a id="references"></a>

## 5 References

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2. [Anderson et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12265875/)
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4. [Bixler et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC10069827/)
5. [Bouquet et al. (2026)](https://doi.org/10.1016/j.jhep.2025.12.025)
6. [Buti et al. (2024)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11599788/)
7. [Buti et al. (2025)](https://doi.org/10.1016/j.jhep.2024.08.010)
8. [CDA-AMC bepirovirsen reimbursement review (2026)](https://www.cda-amc.ca/bepirovirsen)
9. [CDC Clinical Care of Hepatitis B (2025)](https://www.cdc.gov/hepatitis-b/hcp/clinical-care/index.html)
10. [CDC Clinical Overview of Hepatitis B (2025)](https://www.cdc.gov/hepatitis-b/hcp/clinical-overview/index.html)
11. [CDC Clinical Signs and Symptoms of Hepatitis B (2025)](https://www.cdc.gov/hepatitis-b/hcp/clinical-signs/index.html)
12. [CDC Clinical Testing and Diagnosis for Hepatitis B (2026)](https://www.cdc.gov/hepatitis-b/hcp/diagnosis-testing/index.html)
13. [CDC guidelines and quality measures (2026)](https://www.cdc.gov/high-quality-care/hcp/guidelines-quality-measures.html)
14. [CDC Viral Hepatitis Surveillance Report (2025)](https://www.cdc.gov/hepatitis-surveillance-2023/hepatitis-b/index.html)
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21. [ClinicalTrials.gov NCT04449029](https://clinicaltrials.gov/study/NCT04449029)
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23. [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)
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33. [ClinicalTrials.gov NCT06058390](https://clinicaltrials.gov/study/NCT06058390)
34. [ClinicalTrials.gov NCT06058390](https://clinicaltrials.gov/study/NCT06058390?tab=results)
35. [ClinicalTrials.gov NCT06422767](https://clinicaltrials.gov/study/NCT06422767?tab=results)
36. [ClinicalTrials.gov NCT06422767](https://clinicaltrials.gov/study/NCT06422767)
37. [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)
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50. [Ermler et al. (2026)](https://pmc.ncbi.nlm.nih.gov/articles/PMC13482607/)
51. [EU Clinical Trials Information System 2023-504238-23-00](https://euclinicaltrials.eu/ctis-public/view/2023-504238-23-00)
52. [EU Clinical Trials Information System 2023-504239-41-00](https://euclinicaltrials.eu/ctis-public/view/2023-504239-41-00)
53. [EU Clinical Trials Register 2021-005139-22](https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005139-22/GR)
54. [EU Clinical Trials Register 2022-002268-53](https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002268-53/BG)
55. [FDA guidance on chronic hepatitis B drug development (2022)](https://www.fda.gov/media/117977/download)
56. [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment)
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58. [Fierce Pharma (2026)](https://www.fiercepharma.com/pharma/gsk-brings-promise-functional-cure-hepatitis-b-finish-line-fda-nod-hibsago)
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72. [GSK 209348 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/24/NCT04676724/Prot_000.pdf)
73. [GSK 209668 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/29/NCT04449029/Prot_000.pdf)
74. [GSK 209668 statistical analysis plan (2022)](https://cdn.clinicaltrials.gov/large-docs/29/NCT04449029/SAP_001.pdf)
75. [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)
76. [GSK 219239 protocol (2023)](https://cdn.clinicaltrials.gov/large-docs/90/NCT06058390/Prot_000.pdf)
77. [GSK FY2023 results slides (2024)](https://www.gsk.com/media/afnjlfik/fy-2023-results-slides.pdf)
78. [GSK FY2025 pipeline assets and clinical trials appendix (2026)](https://www.gsk.com/media/rs0mbgqw/fy-2025-pipeline-assets-and-clinical-trials-report.pdf)
79. [GSK press release, AASLD 2025 (2025)](https://www.gsk.com/en-gb/media/press-releases/gsk-presents-data-from-its-advancing-liver-pipeline-at-aasld-2025/)
80. [GSK press release, B-Clear results (2022)](https://www.gsk.com/en-gb/media/press-releases/positive-data-for-bepirovirsen-from-b-clear-phase-iib-trial/)
81. [GSK press release, B-Well results (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-achieves-unprecedented-functional-cure-rates-with-potential-to-redefine-treatment-for-chronic-hepatitis-b/)
82. [GSK press release, B-Well topline (2026)](https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-b-well-1-and-b-well-2-phase-iii-trials-for-bepirovirsen-a-potential-first-in-class-treatment-for-chronic-hepatitis-b/)
83. [GSK press release, China acceptance (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-regulatory-review-in-china-as-a-potential-first-in-class-functional-cure-for-chronic-hepatitis-b/)
84. [GSK press release, EMA acceptance (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-review-by-the-european-medicines-agency-as-a-potential-first-in-class-treatment-for-chronic-hepatitis-b/)
85. [GSK press release, Fast Track designation (2024)](https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b/)
86. [GSK press release, FDA priority review (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/)
87. [GSK press release, Hibsago Japan approval (2026)](https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-japan-as-first-and-only-functional-cure-for-chronic-hepatitis-b/)
88. [GSK press release, Hibsago US approval (2026)](https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/)
89. [GSK press release, Japan acceptance (2026)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-regulatory-review-in-japan/)
90. [GSK press release, SBP Group collaboration (2026)](https://www.gsk.com/en-gb/media/press-releases/gsk-enters-exclusive-collaboration-with-sbp-group-a-market-leader-in-hepatology-in-china-to-accelerate-bepirovirsen-at-launch/)
91. [GSK press release, SENKU designation (2024)](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-granted-senku-designation-in-japan-for-chronic-hepatitis-b/)
92. [GSK Q1 2026 results (2026)](https://www.gsk.com/media/hpgfxwxv/q1-2026-results-announcement.pdf)
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190. [Zoulim et al. (2024)](https://pubmed.ncbi.nlm.nih.gov/38971531/)

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