BY THE OPTIMIST DAILY EDITORIAL TEAM

A clinical trial published May 28 in the New England Journal of Medicine reports that a new drug called bepirovirsen achieved a functional cure in approximately one in five patients with chronic hepatitis B.

That number matters. The current standard of care achieves a functional cure in around three percent of patients, and only after eight to 10 years of treatment.

The trial

The B-Well trial enrolled 1,838 adults across 29 countries. Participants received either a weekly injection of bepirovirsen or a placebo for six months, alongside their existing antiviral medication. Among those on the drug, 19 percent achieved a functional cure: their immune systems kept the virus under control without medication for more than six months. In the subgroup with the lowest viral surface antigen levels at the start, the cure rate reached 26 percent.

“We’ve not had a treatment come close to this level of cure,” says Seng Gee Lim, a study co-author and director of hepatology at the National University Health System in Singapore. “I think my patients will be extremely delighted to have this treatment available.”

Anna Suk-Fong Lok, director of clinical hepatology at the University of Michigan Medical School, reviewed the trial as an independent expert. “After many failed trials in the last 10 years, the B-Well Trials’ results provide hope that functional cure for hepatitis B is feasible,” she said.

How the drug works

Bepirovirsen targets the virus two ways. It binds to viral messenger RNA to block production of viral proteins. It also appears to be taken up by macrophages, the immune system’s front-line white blood cells, triggering an immune response against hepatitis B. That makes it function more as an immunomodulator than a standard antiviral, Lok explains: instead of just suppressing the virus indefinitely from the outside, it helps the body’s own defenses take back control.

Who it helps, and who it doesn’t

The results had clear limits. The trial excluded people with cirrhosis, HIV coinfection, or severe disease. The drug worked best in patients whose hepatitis B was already better controlled at the outset.

“That reinforces a critical point: new treatments will only change lives if people are diagnosed early, regularly monitored, and connected to care,” says Jane Davies, an infectious disease specialist at the Royal Darwin Hospital in Australia and director of Hepatitis Australia.

Why this disease needs a breakthrough

More than 240 million people are living with chronic hepatitis B worldwide. Only 13 percent of them know it. The virus can silently damage the liver for years with no symptoms, or only mild ones: fatigue, stomach pain, joint discomfort. Hepatitis B is the second most potent carcinogen after tobacco, and over time it can cause liver scarring, liver failure, and liver cancer. More than one million people die from its complications each year.

“Hepatitis B is a silent killer,” says Lok.

Existing antivirals, which Lok describes as “cheap, safe, and effective,” keep the virus suppressed but rarely clear it. Patients typically stay on medication for life. The hepatitis B vaccine, introduced in 1981, offers close to 100 percent protection and has cut new infections by more than 90 percent in many countries. In the US, birth dosing has averted more than 90,100 potential childhood deaths since 1994. But treatment gaps remain serious, especially in sub-Saharan Africa and the western Pacific, where infection rates are highest and vaccination coverage is lowest. Geoffrey Dusheiko, a hepatologist at the Royal Free Hospital and University College London, calls it “appalling inequity.”

What comes next

GSK has submitted the trial data to regulators in the United States, Canada, Europe, Japan, and China, with approval decisions expected this year. Potential side effects include changes to platelet counts and kidney function, and injection site reactions, all requiring monitoring.

“These are exciting new developments,” Davies says, “but the immediate priority remains the same: find people living with hepatitis B, connect them with culturally safe care, and support them before liver disease or liver cancer develops. This does not have to remain a silent epidemic.”

Source study: New England Journal of Medicine— Phase 3 results of bepirovirsen treatment for chronic Hepatitis B virus infection

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