---
title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Other product development or post-marketing obligations required by the FDA"
description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Other product development or post-marketing obligations required by the FDA. Topics: Populations without established safety and efficacy at approval, Ongoing trial in HIV and HBV coinfection, Ongoing pharmacokinetic study in moderate and severe renal impairment, European Union paediatric investigation plan: agreed measures, and 2 further topics. 6 evidence topics quoted from 5 sources."
canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description/other-product-development-or-post-marketing-obligations-required-by-the-fda"
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: Other product development or post-marketing obligations required by the FDA
## 2.2.2.5 Other Product Development or Post-marketing Obligations Required by the FDA
### Postmarketing requirements and commitments in an FDA approval letter
No evidence found.
### Populations without established safety and efficacy at approval
> “The safety and effectiveness of HIBSAGO have not been established in patients less than 18 years of age.”
> “Insufficient data are available on the safety of HIBSAGO in patients with moderate or severe renal impairment or end stage renal disease (eGFR less than or equal to 59 mL/min/1.73m2).”
> “The safety and efficacy of HIBSAGO in patients with cirrhosis have not been established.”
> “The safety and efficacy of HIBSAGO have not been established in patients with hepatitis C virus (HCV) coinfection.”
> “There are insufficient data on the use of HIBSAGO in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”
Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)
### Ongoing trial in HIV and HBV coinfection
> “This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.”
Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)
### Ongoing pharmacokinetic study in moderate and severe renal impairment
> “The purpose of the study is to understand if blood levels of bepirovirsen are different in adults with kidney disease compared to healthy adults who do not have kidney disease.”
Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356)
### European Union paediatric investigation plan: agreed measures
| Area | Measure |
| --- | --- |
| Clinical studies, Study 1 (206839) | “Open label, randomised, controlled study of pharmacokinetics (PK), safety and efficacy of bepirovirsen in children from 2 years to less than 18 years of age with chronic hepatitis B virus (HBV) infection.” |
| Extrapolation, modelling and simulation studies, Study 2 | “Population PK modelling and Exposure-Response study to determine paediatric doses of bepirovirsen for children from 2 years to less than 18 years of age.” |
| Extrapolation, modelling and simulation studies, Study 3 | “PK bridging/extrapolation of efficacy data to support the use of bepirovirsen for the treatment of chronic hepatitis B in children from 2 years to less than 18 years of age.” |
Source: [EMA paediatric investigation plan decision P/0254/2022 (2022)](https://www.ema.europa.eu/en/documents/pip-decision/p-254-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bepirovirsen-emea-003082-pip01-21_en.pdf)
### European Union paediatric investigation plan: waiver, completion date, and deferral
> “the paediatric population from birth to less than 2 years of age;”
> “Date of completion of the paediatric investigation plan:”
> “By May 2034”
Source: [EMA paediatric investigation plan decision P/0254/2022 (2022)](https://www.ema.europa.eu/en/documents/pip-decision/p-254-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bepirovirsen-emea-003082-pip01-21_en.pdf)
### Further development: sequential daplusiran/tomligisiran followed by bepirovirsen
> “The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy.”
Source: [ClinicalTrials.gov NCT06537414](https://clinicaltrials.gov/study/NCT06537414)
## Related pages
- [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis.md)
- [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Terms and abbreviations](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations.md)
- [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary.md)
- [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Product information and disease description](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description.md)
- [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Clinical evidence](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence.md)
- [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Economic information and modeling report](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics.md)
- [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: References](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references.md)
- [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: new drug review](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review.md)
- [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: cost-effectiveness analyses and utility weights](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses.md)