A new experimental drug for hepatitis B is showing promise.
It offers a “functional cure” for a subset of patients, allowing them to stop treatment without signs of the virus, according to researchers.
The drug bepirovirsen (‘bepi’) was tested on 1,838 participants.
In two studies, about one in five saw their virus reduced to low enough levels for their immune system to keep it in check.
According to Dr. Seng Gee Lim, who helped lead the studies, “We have not had a treatment which has come to this level of cure.”
The New England Journal of Medicine published the data on Thursday.
Dr. Anna Lok, a hepatitis expert at the University of Michigan, wrote that the findings “represent a major step,” but cautioned that more study is needed to see how long the remission-like state lasts.
The chronic infection can cause liver cancer or liver failure.
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It kills about 1.1 million people worldwide each year, and improvements to current lifelong therapy have been sought for decades.
The experimental therapy is under fast-track review by the FDA.
Developed by GSK and Ionis Pharmaceuticals, a decision is expected in October.
The infection is a serious liver infection spread through contact with blood or other bodily fluids, including childbirth, and a highly effective vaccine can prevent it.
Many infected people have an “acute” illness lasting several months.
Some develop a chronic form that damages the liver.
Current therapies reduce viral loads and prevent liver damage.
But a true cure is elusive because the infection can hide in the body and rebound if medication stops.
The therapy attacks the infection by binding to its genetic components.
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It suppresses viral replication and a key protein, the “S” or surface protein, and stimulates the immune system, said GSK vice president Melanie Paff.
Subjects got bepi or dummy shots weekly for six months.
They also took regular pills, and if the virus was undetectable for six months after stopping the shots, they could stop their pills.
About 20% of recipients had the virus undetectable for six more months.
After stopping all treatment, they achieved “this cure,” something no participants given the dummy shots achieved.
Lower protein levels increased the chance of achieving that state.
Lim said so.
Most individuals from earlier studies fared well up to three years later.
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Paff said this.
Side effects included mild injection-site redness or pain.
A temporary rise in enzymes can indicate liver stress.
The trials did not include participants with cirrhosis or high protein levels.
Other complicating factors were also excluded.
The therapy is under regulatory review in several countries.
These include the United States, Japan, China, and Europe.
A decision is expected in October in the US.
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