Chronic hepatitis B treatment “can mean taking antiviral medication for years,” the U.S. Food and Drug Administration said. On Oct. 20, the agency approved a hepatitis B drug, Hibsago, that could let some patients stop those antivirals. It is an add-on for adults without cirrhosis, and most patients in the trials did not reach that result.
At a glance
- FDA approval: Hibsago (bepirovirsen), made by GSK, is approved for use alongside existing antiviral treatment, Contagion Live reported.
- Functional cure: In two placebo-controlled trials, 19% of patients reached one, compared with none on placebo.
- Eligible patients: Adults without cirrhosis who have taken antivirals for at least six months and have low levels of a viral surface protein.
What the hepatitis B drug does
GSK describes Hibsago as an RNA-targeted medicine. Patients get weekly injections for up to 24 weeks while staying on their antivirals, Contagion Live reported. After the first dose, they can give the shots themselves.
The goal is a functional cure. That means no detectable virus or surface protein in the blood at least 24 weeks after all treatment stops.
Wendy Carter, an FDA official, said the drug gives some patients “the possibility of maintaining control of the virus,” HCPLive reported.
What the trials found
The two phase 3 trials, called B-Well 1 and B-Well 2, ran in 29 countries and were published in the New England Journal of Medicine. Of 1,220 patients given the drug, 233 (19%) reached a functional cure. None of the 614 patients on placebo did, GSK and Ionis reported.
The rate was 26% (200 of 768) in patients who started with lower levels of the surface protein. Also, 24% of patients met the FDA’s criteria to stop their antivirals, and none on placebo did.
GSK says standard care produces a functional cure in under 1% of patients. That figure compares across studies and is not a head-to-head trial.
Who can use it, and the risks
The approval covers adults without cirrhosis. They must have taken antivirals for at least six months and have suppressed virus levels. Their surface protein level must be 3,000 IU/mL or lower on an FDA-authorized test, Contagion Live reported.
The label carries a boxed warning for liver flares and low platelet counts, which can raise the risk of bleeding. Patients need platelet checks every week during treatment.
In the trials, 16% of patients on the drug had a severe side effect (grade 3 or higher), compared with 3% on placebo, HCPLive reported.
What remains unresolved
More than 80% of trial patients on the drug did not reach a functional cure. The published results measure it about six months after treatment ends, so how long it lasts is not yet known. HCPLive noted that a functional cure does not necessarily mean the virus is fully gone.
Price and launch timing were not stated in the approval coverage. Japan approved Hibsago first, in an announcement GSK dated Aug. 24.
What comes next
GSK estimates that about 1.7 million people in the U.S. and more than 240 million worldwide live with chronic hepatitis B, Pharmaceutical Executive reported. GSK expects decisions from regulators in other regions in the coming months.
Norah Terrault of USC Keck Medical Center called it “the start of a new era” in a GSK statement.
Read more
For more on this story, see: GSK and Ionis approval announcement and Contagion Live
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