--- title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: B-Kind renal impairment study" description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: B-Kind renal impairment study. Covers Objective, Location and study date, Study design, Eligibility criteria, Treatment, Study outcomes, and 2 further headings. 12 evidence topics quoted from 2 sources." canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence/b-kind-renal-impairment-study" 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: B-Kind renal impairment study ## 3.1.13 B-Kind Renal Impairment Study ### 3.1.13.1 Objective #### Aim stated in the registry record > “This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood. 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) ### 3.1.13.2 Location and Study Date #### Study dates and status in the registry record | Field | Registry entry | | --- | --- | | Recruitment status | “Active, not recruiting” | | Study start (actual) | “2025-09-26” | | Primary completion (actual) | “2026-03-03” | | Study completion (estimated) | “2026-08-18” | | First posted | “2025-09-11” | | Last update posted | “2026-05-22” | Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) #### Study locations in the registry record > “This study has 3 locations” > “Orlando, Florida, United States, 32809” > “Tampa, Florida, United States, 33603” > “San Antonio, Texas, United States, 78215” Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) ### 3.1.13.3 Study Design #### Phase 1, open-label, single-dose, parallel-group design > “A Phase 1, Open-Label, Single-Dose, Parallel Group, 2-Part Study to Evaluate the Pharmacokinetics of Bepirovirsen in Adult Participants With Severe or Moderate Renal Impairment Compared to Matched Healthy Control Participants” Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) #### Design details in the registry record | Field | Registry entry | | --- | --- | | Allocation | “Non-Randomized” | | Interventional model | “Parallel Assignment” | | Masking description | “This is an open-label study.” | | Phase | “Phase 1” | | Other study identifiers | “205872” | Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) ### 3.1.13.4 Eligibility Criteria #### Renal function groups > “Severe renal impairment [estimated glomerular filtration rate (eGFR) adjusted for actual body surface area (BSA) less than 30 milliliters per minute (ml/min); Group 1] or moderate renal impairment [eGFR adjusted for actual BSA between 30 and 59 ml/min; Group 2], from any cause other than vasculitis or glomerulonephritis Additional inclusion criteria for healthy control participants with normal renal function (Group 3)” > “Normal renal function (eGFR adjusted for actual BSA greater than or equal to 90 ml/min)” Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) #### Other inclusion and exclusion criteria > “Age 18 to 80 years, inclusive” > “Body weight greater than or equal to 50 kilograms (kg) and body mass index (BMI) within the range 19 to 40 kilograms per square meter (kg/m^2).” > “A positive blood test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).” > “On dialysis or likely to require dialysis during the study.” > “History of renal transplantation or anticipated renal transplant during the study.” Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) ### 3.1.13.5 Treatment #### Single dose of bepirovirsen in each group > “Participants with severe renal impairment will receive Bepirovirsen.” > “Participants with moderate renal impairment will receive Bepirovirsen.” > “Healthy control participants will receive Bepirovirsen.” Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) ### 3.1.13.6 Study Outcomes #### 3.1.13.6.1 Rationale for Using Plasma AUC and Cmax as the Primary Endpoints ##### Registered primary and secondary outcomes > “Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen” > “Maximum Observed Concentration (Cmax) of Bepirovirsen” > “Apparent Clearance (CL/F) of Bepirovirsen” > “Apparent Terminal Phase Half-life (t1/2) of Bepirovirsen” Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) ##### Renal impairment data gap in the prescribing information > “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).” > “Renal Impairment: Bepirovirsen pharmacokinetics were similar between patients with CHB with an eGFR 60 to 89 mL/min/1.73m2 compared to patients with an eGFR ≥90 mL/min/1.73 m2. Insufficient data are available in patients with moderate or severe renal impairment.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### 3.1.13.7 Statistical Analysis Description #### 3.1.13.7.1 Number of Participants (Planned and Analyzed) ##### Enrollment in the registry record | Field | Registry entry | | --- | --- | | Enrollment (actual) | “32” | Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356) #### 3.1.13.7.2 Description of Analysis Sets No evidence found. ### 3.1.13.8 Results #### 3.1.13.8.1 Participant Disposition No evidence found. #### 3.1.13.8.2 Baseline Characteristics No evidence found. #### 3.1.13.8.3 Efficacy Results No evidence found. #### 3.1.13.8.4 Health-related Quality of Life and Patient-reported Outcomes Not applicable. #### 3.1.13.8.5 Safety Results No evidence found. ### 3.1.13.9 Study Limitations #### Summary: study limitations B-Kind reached primary completion on 2026-03-03 with 32 participants enrolled, but no results are posted on ClinicalTrials.gov and no publication was identified, and the prescribing information states that data are insufficient in moderate or severe renal impairment. The 32 participants are divided among three groups, each participant receives a single dose, and the registry excludes participants with a positive hepatitis B test, dialysis, or renal transplantation. Source: [ClinicalTrials.gov NCT07168356](https://clinicaltrials.gov/study/NCT07168356); [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ## 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)