A New FDA-Approved Option
Hibsago is the first FDA-approved antisense oligonucleotide for chronic hepatitis B, approved for certain adults without cirrhosis.
Who May Qualify
Adults need at least six months of HBV antivirals, suppressed virus levels, and HBsAg no higher than 3,000 IU/mL.
A Companion Test Helps
An FDA-authorized companion test helps select patients under approved labeling and supports monitoring during Hibsago treatment.
How Hibsago Works
Hibsago targets genetic instructions HBV uses to make copies and viral proteins, helping reduce virus and surface antigen levels.
Treatment Continues Alongside It
Injections are given under the skin for up to 24 weeks, alongside existing antivirals, which continue at least 24 weeks afterward.
What Trials Found
Trials: 24% qualified to stop antivirals versus none on placebo; after treatment ended, 19% maintained control without detectable HBsAg 24 weeks later.
Serious Risks Need Monitoring
Boxed warnings cover serious liver reactions and low platelets, which can raise bleeding risk; regular blood tests and provider follow-up are needed.
Read More From The FDA
Read the FDA announcement for full eligibility details, trial findings, safety warnings, and information about Hibsago’s approval.