FDA Approves GSK's Hibsago (Bepirovirsen) With Nucleos(t)ide Analogues for Chronic Hepatitis B

On October 20, FDA approved GSK's antisense oligonucleotide Hibsago (bepirovirsen) for use with nucleos(t)ide analogues in certain adults with chronic hepatitis B. Eligible patients have no cirrhosis, have received at least 6 months of antiviral therapy, have suppressed viral DNA, and have baseline HBsAg of 3000 IU/mL or below. The article calls the regimen a breakthrough toward functional cure for hepatitis B patients.