Name: Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Indication
Published: 2026-10-21T22:39:04-04:00

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:” (opens the prescribing information at this quote)
“who have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA), and” (opens the prescribing information at this quote)
“who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test” (opens the prescribing information at this quote)

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:” (opens the prescribing information at this quote)
“HIBSAGO is administered by subcutaneous injection and must be used in combination with NrtI therapy.” (opens the prescribing information at this quote)

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” (opens the source at this quote in a new tab)

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.” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)

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):” (opens the prescribing information at this quote)
“who have been on NrtI treatment for at least 6 months and have undetectable HBV deoxyribonucleic acid (DNA),” (opens the prescribing information at this quote)
“who have low levels of HBV surface antigen (HBsAg less than or equal to 3,000 IU/mL)” (opens the prescribing information at this quote)

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.” (opens the source at this quote in a new tab)

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” (opens the prescribing information at this quote)
“Information on FDA-authorized tests for the quantification of HBsAg levels is available at:” (opens the prescribing information at this quote)

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)” (opens the prescribing information at this quote)
“Patients with platelet count below 100 x 109/L prior to initiation of treatment” (opens the prescribing information at this quote)
“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.” (opens the prescribing information at this quote)
“The safety and effectiveness of HIBSAGO have not been established in patients less than 18 years of age.” (opens the prescribing information at this quote)
“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.” (opens the prescribing information at this quote)

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” (opens the source at this quote in a new tab)
“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).” (opens the source at this quote in a new tab)