--- title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Co-prescribed/Concomitant therapies" description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Co-prescribed/Concomitant therapies. Topics: Required nucleos(t)ide analog reverse transcriptase inhibitor therapy; Nucleos(t)ide analog therapy in B-Well 1 and B-Well 2: continuation, cessation, and restart; Nucleos(t)ide analogs used with bepirovirsen in clinical trials: entecavir and tenofovir; Nucleos(t)ide analog therapy at baseline in B-Together; 5 further topics. 9 evidence topics quoted from 6 sources." canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description/co-prescribed-concomitant-therapies" 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: Co-prescribed/Concomitant therapies ## 2.1.2.12 Co-prescribed/Concomitant Therapies ### Required nucleos(t)ide analog reverse transcriptase inhibitor therapy > “HIBSAGO is administered by subcutaneous injection and must be used in combination with NrtI therapy.” > “HIBSAGO must be used in combination with NrtI therapy. Refer to the NrtI prescribing information for additional information.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Nucleos(t)ide analog therapy in B-Well 1 and B-Well 2: continuation, cessation, and restart > “were receiving stable NrtI therapy (defined as no changes due to loss of virologic control for ≥6 months before the start of the trial and no plans for changes over the duration of the trial)” > “From Week 25 to 48, participants continued to receive their NrtI therapy without HIBSAGO or placebo.” > “At Week 48, participants who met the prespecified NrtI cessation eligibility criteria discontinued NrtI therapy.” > “Through Week 96, among the 84 HIBSAGO recipients who discontinued NrtI therapy but did not achieve the primary endpoint at Week 72 (62 participants) or who achieved the primary endpoint but did not maintain a sustained response at Week 96 (22 participants), one participant met criteria to restart NrtI therapy. Protocol-defined criteria to restart NrtI therapy included HBV DNA >20,000 IU/mL at a single visit, HBV DNA >2,000 IU/mL at two sequential visits, confirmed HBeAg reversion, or clinical/hepatic decompensation. Out of the 84 participants, three additional participants restarted NrtI therapy within one month of NrtI cessation without having met the protocol-defined NrtI restart criteria.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) > “Participants who have documented chronic HBV infection ≥6 months prior to screening and currently receiving stable NA therapy defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen over the duration of the study.” > “Participants who are willing and able to cease their NA treatment in accordance with the protocol.” Source: [ClinicalTrials.gov NCT05630807](https://clinicaltrials.gov/study/NCT05630807); [ClinicalTrials.gov NCT05630820](https://clinicaltrials.gov/study/NCT05630820) ### Nucleos(t)ide analogs used with bepirovirsen in clinical trials: entecavir and tenofovir > “Entecavir (ETV) and tenofovir (TFV) are the most commonly used NAs” > “NAs such as lamivudine and adefovir were used in only 4 of 227 (1.8%) On‐NA participants in B‐Clear.” > “the NCA PK parameters from 5 subjects receiving TAF in the B‐Clear study were similar to the published data on TAF (Table 3).” Source: [Han et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11975176/) ### Nucleos(t)ide analog therapy at baseline in B-Together | Current NA therapy | Arm 1 (bepirovirsen 24 weeks), n (%) | Arm 2 (bepirovirsen 12 weeks), n (%) | Total, n (%) | | --- | --- | --- | --- | | TAF or TDF | “33 (61)” | “37 (70)” | “70 (65)” | | Entecavir | “19 (35)” | “12 (23)” | “31 (29)” | | Other | “2 (4)” | “4 (8)” | “6 (6)” | Source: [Buti et al. (2025)](https://doi.org/10.1016/j.jhep.2024.08.010) > “Other NA medications included tenofovir, tenofovir disoproxil, lamivudine or tenofovir alafenamide.” > “currently receiving stable NA therapy (defined as no changes to their NA regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study) except telbivudine.” Source: [Buti et al. (2025)](https://doi.org/10.1016/j.jhep.2024.08.010) ### Pharmacokinetic interaction with entecavir and tenofovir > “Bepirovirsen plasma pharmacokinetic parameters and concentration–time profiles in patients with chronic HBV in the CS3 study (NCT02981602) were similar with or without ETV or TFV coadministration, indicating no effect of NA coadministration on bepirovirsen pharmacokinetics.” > “In patients with chronic HBV receiving both bepirovirsen and ETV or TFV in the B‐Clear study (NCT04449029), NA plasma concentrations and pharmacokinetic parameters were similar to those published without bepirovirsen coadministration, suggesting no effect of bepirovirsen coadministration on NA pharmacokinetics.” Source: [Han et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11975176/) ### Antiviral activity in combination with entecavir or tenofovir and cross-resistance > “Combining bepirovirsen with entecavir or tenofovir disoproxil fumarate in HepG2.2.15 cells (HBV genotype D, transfection-based delivery) resulted in no antagonism and greater reductions of intracellular HBV DNA by qPCR compared to the individual drugs.” > “Cross-resistance between bepirovirsen and NrtIs including entecavir and tenofovir is not expected.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Peginterferon alfa-2a: concomitant use not recommended > “Concomitant administration of HIBSAGO and peginterferon alfa-2a is not recommended due to the potential for an exacerbated risk of increased ALT, decreased platelet count, and immune-mediated effects.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Antiretroviral therapy in HIV and HBV coinfection > “Advise patients living with HIV who are taking NrtI therapy for both HIV and HBV to not discontinue NrtI therapy except under the direct supervision of an HIV healthcare provider” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) > “Must be on uninterrupted antiretroviral therapy (ART) containing at least tenofovir disoproxil (TDF) or tenofovir alafenamide (TAF) plus lamivudine (3TC) or emtricitabine (FTC)” Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504) ### Concomitant medications restricted in B-Well 1 and B-Well 2 > “Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (≤2 weeks) or topical/inhaled steroid use.” > “Currently taking, or has taken within 12 months of Screening, any interferon containing therapy.” > “Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of the study, by the discretion of the investigator. Occasional use is permitted.” > “Prior treatment with any oligonucleotide or siRNA within 12 months prior to the first dosing day.” Source: [ClinicalTrials.gov NCT05630807](https://clinicaltrials.gov/study/NCT05630807); [ClinicalTrials.gov NCT05630820](https://clinicaltrials.gov/study/NCT05630820) ## 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)