FDA Approves Bepirovirsen as a Functional Cure Option for Chronic Hepatitis B

The FDA approved bepirovirsen (Hibsago) on Tuesday for adults with chronic hepatitis B who do not have cirrhosis and are receiving antiviral therapy, offering the possibility of a functional cure.

The approval was supported by results from the phase III B-Well 1 and B-Well 2 trials. Nearly one in five patients who received the antisense oligonucleotide along with background antiviral therapy achieved a functional cure, compared with no patients in the placebo groups.

“This is the start of a new era in treating people living with chronic hepatitis B,” said Norah Terrault, MD, an investigator at the Keck School of Medicine at the University of Southern California in Los Angeles, in a statement from GSK. “Bepirovirsen offers patients the potential to achieve a functional cure after a short period of treatment, a long-standing goal for patients and physicians alike.”

At week 72, 19% to 20% of patients with hepatitis B surface antigen levels of 3,000 IU/mL or less achieved a functional cure with bepirovirsen. Among those with levels of 1,000 IU/mL or less—accounting for about 45% of diagnosed cases worldwide—the functional cure rate reached 26%.

Chronic hepatitis B virus infection can lead to severe liver disease, including cirrhosis. More than half of liver cancer cases worldwide are associated with hepatitis B.

Bepirovirsen is administered as a six-month course and may be self-administered after the initial dose. It is intended for use with nucleos(t)ide analog reverse transcriptase inhibitor therapy in patients who have received antiviral treatment for at least six months, have suppressed HBV blood levels and have hepatitis B surface antigen levels of 3,000 IU/mL or less.

“Bepirovirsen provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended,” said Wendy Carter, DO, of the FDA’s Center for Drug Evaluation and Research. “This approval represents an important advance for people living with this serious disease.”

The most common adverse effects include injection-site reactions, fatigue, fever and headache.

The FDA-approved prescribing information includes a boxed warning about serious hepatic flares during treatment and low platelet counts, which can cause life-threatening thrombocytopenia. Other warnings include the risk of worsening kidney function, serious inflammatory reactions such as vasculitis, and complications from improper injection. Regular blood tests are required for patients receiving bepirovirsen. The drug is not recommended for patients with hepatitis D virus coinfection.

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