FDA Approves New Antisense Drug for Chronic Hepatitis B

The FDA has approved Hibsago (bepirovirsen), an antisense oligonucleotide, for certain adults with chronic hepatitis B who do not have cirrhosis, according to an FDA press release. This is an approved medication, not an investigational compound, and it is meant to be used alongside existing antiviral therapy rather than as a standalone cure.

Eligible patients must have been on antiviral treatment for at least six months, have suppressed HBV levels, and have surface antigen levels at or below a set threshold measured by an FDA authorized test. Hibsago is given by injection under the skin for up to 24 weeks, continuing alongside standard antiviral medicine for at least 24 more weeks.

Across two placebo controlled trials, 24% of patients who received Hibsago met criteria to stop their existing antiviral medicine entirely, compared with none in the placebo group. Twenty four weeks after stopping all treatment, 19% still had the virus controlled with no detectable surface antigen.

The drug carries a boxed warning for serious liver reactions and low platelet counts, along with warnings about kidney function and inflammatory reactions. Common side effects include injection site reactions, fever, fatigue, and headache. The approval went to GSK plc.

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