“The U.S. Food and Drug Administration today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis…
'For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,' said Wendy Carter, DO, Acting Director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research. 'Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.' …
Researchers studied Hibsago in two clinical trials that compared it with a placebo, an inactive treatment. 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. Some patients may then be able to stop their existing medicine if they meet certain health and lab test requirements.
Across the two trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none who received placebo. Twenty-four weeks after stopping all hepatitis B treatment, 19% of patients who received Hibsago still had the virus under control, and a protein that signals hepatitis B infection (HBsAg) could not be detected in their blood.”
