---
title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Indication"
description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Indication. Topics: U.S. indication: full prescribing information, U.S. indication: Highlights of prescribing information, U.S. indication: FDA-approved use on the novel drug approvals list, U.S. indication: FDA plain-language description, and 5 further topics. 9 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/indication"
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: Indication

<a id="heading-2.1.2.5"></a>

## 2.1.2.5 Indication

<a id="topic-2.1.2.5-1"></a>

### U.S. indication: full prescribing information

> “HIBSAGO is indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis:”
> “who have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA), and”
> “who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test”

Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

<a id="topic-2.1.2.5-2"></a>

### U.S. indication: Highlights of prescribing information

> “HIBSAGO is a hepatitis B virus (HBV) mRNA-directed antisense oligonucleotide (ASO) indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic HBV infection in adult patients without cirrhosis:”
> “HIBSAGO is administered by subcutaneous injection and must be used in combination with NrtI therapy.”

Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

<a id="topic-2.1.2.5-3"></a>

### U.S. indication: FDA-approved use on the novel drug approvals list

> “To treat chronic hepatitis B virus infection in certain adults without cirrhosis, in combination with existing antiviral therapy”

Source: [FDA Novel Drug Approvals for 2026 (2026)](https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026)

<a id="topic-2.1.2.5-4"></a>

### U.S. indication: FDA plain-language description

> “Hibsago is approved for certain adults without cirrhosis who have been taking HBV antiviral therapy for at least six months, have suppressed levels of HBV in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test.”
> “Hibsago is injected under the skin for up to 24 weeks. Patients take it alongside their existing hepatitis B medicine and continue that medicine for at least 24 weeks after their last Hibsago injection.”

Source: [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment)

<a id="topic-2.1.2.5-5"></a>

### U.S. indication: patient information wording

> “HIBSAGO is a prescription medicine used with other medicines called nucleos(t)ide analog reverse transcriptase inhibitors (NrtIs), to treat adults with chronic (long-term) hepatitis B virus (HBV) infection without advanced liver disease (cirrhosis):”
> “who have been on NrtI treatment for at least 6 months and have undetectable HBV deoxyribonucleic acid (DNA),”
> “who have low levels of HBV surface antigen (HBsAg less than or equal to 3,000 IU/mL)”

Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

<a id="topic-2.1.2.5-6"></a>

### U.S. indication: partner company wording

> “HIBSAGO is indicated in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy to treat chronic hepatitis B virus (HBV) infection in adults without cirrhosis who have been on NrtI therapy for ≥6 months with suppressed HBV DNA and who have HBV surface antigen (HBsAg) levels ≤3,000 IU/mL as determined by an FDA-authorized test.”

Source: [Ionis press release, Hibsago US approval (2026)](https://ir.ionis.com/news-releases/news-release-details/ionis-partner-gsk-announces-hibsago-bepirovirsen-approved-us)

<a id="topic-2.1.2.5-7"></a>

### Baseline HBsAg testing required for patient selection

> “Prior to initiation of HIBSAGO for treatment of chronic HBV infection, test all patients to quantify HBsAg levels in serum or plasma to identify patients with baseline HBsAg levels less than or equal to 3,000 IU/mL”
> “Information on FDA-authorized tests for the quantification of HBsAg levels is available at:”

Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

<a id="topic-2.1.2.5-8"></a>

### Populations excluded from or not studied under the indication

> “Patients with acute hepatic impairment, or cirrhosis who have mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B or C)”
> “Patients with platelet count below 100 x 109/L prior to initiation of treatment”
> “HIBSAGO is not recommended in patients with Hepatitis D Virus (HDV) coinfection due to the potential for an exacerbated risk of clinically significant ALT increases.”
> “The safety and effectiveness of HIBSAGO have not been established in patients less than 18 years of age.”
> “It is not known if HIBSAGO is safe and effective in people who also have hepatitis C virus (HCV) or hepatitis D virus (HDV) infection.”

Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

<a id="topic-2.1.2.5-9"></a>

### Japan indication

> “GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Hibsago (bepirovirsen), an antisense oligonucleotide (ASO), as a functional cure for chronic hepatitis B (CHB) virus infection in adult patients who have received at least 6 months of prior nucleos(t)ide analogue therapy and meet pre-defined viral markers”
> “Hibsago (bepirovirsen) has been approved as a functional cure in chronic hepatitis B (CHB) virus infection in patients who have received nucleos (t) ide analogue therapy for at least 6 months before starting this drug and whose HBs antigen level at starting this drug is ≤ 3000 IU/mL and HBV DNA level is < 90 IU/mL (1.95logIU/mL).”

Source: [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/)

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