How a new drug shows promise as a 'functional cure' for Long Island's chronic hepatitis B patients

A first-of-its-kind drug has provided a "functional cure" in about 20% of patients with chronic hepatitis B infections, providing a possible lifeline for sufferers on Long Island, which has the highest rate of new cases of the potentially deadly liver disease in the state outside of New York City, officials and medical researchers said.

In two international studies published Thursday in the New England Journal of Medicine, about 1 in 5 patients given bepirovirsen — nicknamed "bepi" — experienced virus reduction to undetectable levels.

Bepirovirsen, however, is limited to patients with the chronic form of the infection, as opposed to new infections, researchers said.

Here is what Long Islanders should know about the drug and how it could affect patients locally.

 What is hepatitis B?

Hepatitis B, which is contracted through blood, semen or other body fluids from an infected person, kills about 1.1 million people globally each year.

While hepatitis B can be prevented with a vaccine, about 1.7 million people in the United States — and more than 250 million worldwide — have acquired the chronic form of the infection, experts said. Chronic hepatitis B lasts longer than six months and can lead to cirrhosis, liver cancer and death.

Standard treatments, including daily pills, typically reduce virus levels and prevent liver damage. But experts contend a true cure has been elusive for years because hepatitis B has the ability to hide in the body and can return if therapy stops. Treatment for the virus is lifelong, requiring antivirals and drugs that boost the immune response.

What did the two studies show about controlling or effectively curing the virus?

The trials included 1,838 patients in 29 countries in Asia, Europe, and North and South America who received either a bepirovirsen shot or a placebo shot weekly for six months, in addition to their regular pills. 

In about 20% of bepi recipients, the virus remained undetectable for at least six months after they completed all treatments, which researchers described as a "functional cure."

The medication is under fast-track review by the Food and Drug Administration, with a decision expected in October.

Dr. James Park, chief of hepatology and co-director of the Center for Liver Disease and Transplantation at Northwell Health, described bepirovirsen as a "potentially major medical breakthrough" but said it comes with obvious limitations.

"This is not a magic cure," Park said, pointing to the 20% success rate and the current lack of FDA approval. "But if this does get approved, patients at least have an increased chance of controlling the infection."

How many new cases of hepatitis B have been reported in New York State?

In 2024, 2,087 cases of hepatitis B were newly reported to the New York State Health Department, a 3% drop compared to 2023 after several years of increases, according to the agency's most recent annual report. The overwhelming majority of newly reported cases of hepatitis B in New York are chronic, the report shows.

It is estimated that about half of people with hepatitis B statewide are unaware of their infection status, the report said. Most people with chronic hepatitis B do not have any symptoms, don't feel ill and remain symptom-free for decades, the department said.

When and if symptoms do appear, they are similar to those of a new infection but can often be a sign of advanced liver disease.

Cadence Acquaviva, a Health Department spokeswoman, said officials are "encouraged by the latest findings related to bepirovirsen as a potential treatment option for some people living with chronic hepatitis B infection. Bepirovirsen is currently under priority review by the U.S. Food and Drug Administration and has received both Breakthrough Therapy and Fast Track designations. There is a safe and effective vaccine to prevent hepatitis B infection that's recommended for all children, adults aged 19-59 and those aged 60 and older who are at an increased risk."

What about numbers on Long Island?

In 2024, Nassau and Suffolk combined for 903 new hepatitis B cases — a nearly 150% increase compared to the 362 cases in the Lower Hudson Valley, the region with the second-most new cases outside of New York City, state data shows. Nassau reported 602 new cases in 2024 while Suffolk had 301, figures show.

"This is a virus that is extremely challenging to treat," said Dr. Pruthvi Patel, a gastroenterologist at Mount Sinai South Nassau Hospital in Oceanside. "So, this is remarkable. Patients should be very excited and delighted. ... In my entire career over 15 years, I've maybe had four people who've achieved a functional cure. So if this means that 1 in every 5 patients of mine who are living with chronic hep B achieve functional cure, that would be amazing." 

With The Associated Press

By Robert Brodsky

robert.brodsky@newsday.com@BrodskyRobert

Robert Brodsky is a breaking news reporter who has worked at Newsday since 2011. He is a Queens College and American University alum.