GSK's functional cure data for hepatitis B drug bepirovirsen are a major leap over standard of care

GSK's bepirovirsen, an RNA‑targeting antisense oligonucleotide developed with Ionis, has achieved a statistically significant and clinically meaningful functional cure rate in chronic hepatitis B when added to standard nucleos(t)ide analog therapy.

Pooled Phase III B‑Well 1 and B‑Well 2 trials show that bepirovirsen plus standard of care produced a 19% functional cure rate in adults with baseline HBsAg ≤3,000 IU/mL versus 0% with standard of care alone; in patients with baseline HBsAg ≤1,000 IU/mL the functional cure rate reached about 26% versus 0% on placebo.

These functional cure rates are markedly higher than the less than 1% functional cure rates typically seen with current standard‑of‑care therapy, which usually requires lifelong treatment, leading regulators and analysts to describe the data as a major leap toward a functional cure for chronic hepatitis B.

Regulatory agencies in the United States, European Union, and China have accepted GSK's bepirovirsen submissions for priority or accelerated review as a potential first‑in‑class functional cure for chronic hepatitis B, underscoring the clinical significance of the results.