Bepirovirsen shows promise as treatment for Chronic Hepatitis B Infection in trials

The composite primary outcome of the study was a hepatitis B surface antigen below the detection limit and an HBV DNA level below the quantification limit maintained for 24 weeks following the planned end of the bepirovirsen treatment without new initiation of antiviral medications.

The study led to the following findings:

• The intention-to-treat population comprised 457 participants; 227 received NA therapy, and 230 did not receive NA therapy).
• Among those who received NA therapy, a primary-outcome event occurred in 9% of participants in group 1, 9% in group 2, 3% in group 3, and 0% in group 4.
• Among those who did not receive NA therapy, a primary-outcome event occurred in 10%, 6%, 1%, and 0%.
• During weeks 1 through 12, injection-site reactions, fatigue, pyrexia and increased alanine aminotransferase levels (adverse events) were more familiar with bepirovirsen (groups 1, 2, and 3) compared to placebo (group 4).

"Bepirovirsen sustained clearance of both HBV surface antigen and DNA for a modest proportion of patients out to 6 months following stoppage of injections," the researchers wrote. "Longer and larger trials are needed to examine the safety and efficacy of bepirovirsen."

At that point, 9% of patients with chronic HBV infection either got two 24-week dose regimens for SC injections of bepirovirsen and nucleoside analogues, and 10% remained below quantification or detection level not taking NA but on the highest dose of bepirovirsen for 24 weeks.

Reference:

The study, "Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection," was published in the New England Journal of Medicine (NEJM).

DOI: 10.1056/NEJMoa2210027