A new Bepirovirsen treatment may mark a major breakthrough in the fight against chronic hepatitis B after researchers reported that some patients were able to stop therapy without signs of the virus returning.

The experimental hepatitis B drug, developed by GSK and Ionis Pharmaceuticals, demonstrated what scientists describe as a “functional cure” in roughly 20% of patients involved in two international clinical studies.

The findings were presented Thursday at a medical conference in Barcelona and published in the New England Journal of Medicine.

Researchers see major progress in hepatitis B treatment

Chronic hepatitis B remains one of the world’s deadliest infectious diseases, causing liver failure and liver cancer in millions of people worldwide.

Current treatments help suppress the virus but usually require lifelong medication because hepatitis B can remain hidden in the body and reactivate if therapy stops.

Researchers say bepirovirsen could change that.

“We have not had a treatment which has come to this level of cure,” said Seng Gee Lim, one of the lead investigators involved in the studies.

The experimental drug works by targeting the virus’s genetic material and suppressing production of a key surface protein linked to viral replication. Scientists say the therapy may also help stimulate the body’s immune response against the infection.

About 1 in 5 patients reached a functional cure

The studies involved 1,838 patients who received weekly injections of bepirovirsen for six months while continuing their standard hepatitis B medication.

Patients whose virus remained undetectable for six months after treatment were then allowed to stop their daily therapy.

Researchers found that around 20% of patients receiving the experimental drug maintained undetectable virus levels for another six months without additional treatment.

No patients who received placebo injections achieved the same outcome.

Scientists noted that patients with lower levels of the hepatitis B surface protein at the beginning of the trial appeared more likely to respond successfully.

FDA decision expected later this year

The drug is currently under fast-track review by the U.S. Food and Drug Administration, with a decision expected in October. Regulators in Europe, Japan and China are also reviewing the treatment.

Researchers caution that more long-term data is needed to determine how durable the functional cure may be.

Anna Lok, who was not involved in the research, described the findings as “a major step” but emphasized that additional study is necessary.

According to GSK, some patients from earlier-stage trials have maintained virus suppression for up to three years after treatment.

Side effects appeared manageable

Researchers reported mostly mild side effects, including redness or pain at injection sites and temporary increases in liver enzymes.

The studies did not include some higher-risk patients, such as people with cirrhosis or very high viral protein levels, meaning additional research will still be required before the treatment can be widely used.

Still, experts say the results represent one of the most promising advances in hepatitis B treatment in decades.

Author: Staff Writer | Edited for WTFwire.com | SOURCE: CNN News