Treatment with the investigational antisense oligonucleotide bepirovirsen led to functional cure in one in five patients with chronic hepatitis B virus (HBV) infection, the phase III B-Well 1 and B-Well 2 trials showed.
Among patients taking stable nucleoside or nucleotide analogue (NA) therapy, 20% and 19% of those taking bepirovirsen in the two trials, respectively, had a functional cure at week 72 compared with no patients taking placebo, reported Seng-Gee Lim, MD, of the National University Health System in Singapore, at the European Association for the Study of the Liver annual meeting in Barcelona.
The common risk difference between bepirovirsen and placebo was 17.5 percentage points in B-Well 1 (95% CI 14.6-20.3) and 13.3 percentage points in B-Well 2 (95% CI 10.4-16.1; P<0.001 for both comparisons).
The twin trials' findings, which were published simultaneously in the New England Journal of Medicine, "will change the landscape of hepatitis B treatment," Lim said during his presentation.
In an accompanying editorial, Anna Lok, MD, of the University of Michigan in Ann Arbor, noted that the B-Well studies' results were "remarkable" and "represent a major step toward a functional cure for HBV infection."
