GSK Hepatitis B Drug Shows Functional Cure in 20 Percent of Trial Patients

Researchers reported that an experimental drug called bepirovirsen produced a functional cure in about 20 percent of patients with chronic hepatitis B. The results come from two international studies involving 1,838 participants and were presented Thursday in Barcelona while published simultaneously in the New England Journal of Medicine.

In the trials, patients received weekly injections of bepirovirsen or placebo for six months alongside their existing medication. Those whose virus remained undetectable for six months after stopping the shots were allowed to discontinue daily pills.

None of the placebo recipients met this threshold, while roughly one in five bepirovirsen recipients maintained undetectable virus levels for an additional six months.

Study Details and Patient Outcomes Dr.

Seng Gee Lim of the National University Health System of Singapore, who co-led the GSK-funded studies, said no prior treatment has reached this level of response. Patients who entered the study with lower levels of the hepatitis B surface protein showed slightly higher rates of functional cure.

Melanie Paff, GSK vice president, explained that the drug binds to viral genetic material, suppresses replication and the surface protein, and stimulates the immune system. Reported side effects included mild injection-site reactions and temporary enzyme elevations.

Regulatory Status and Next Steps The U.S.

Food and Drug Administration is conducting a fast-track review of bepirovirsen, with a decision anticipated in October. Regulators in Japan, China, and Europe are also evaluating the drug. Dr. Anna Lok of the University of Michigan, who was not involved in the research, described the data as a major step but noted that longer-term studies are needed to confirm durability.

The trials excluded patients with cirrhosis or other complicating factors.