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WASHINGTON (AP) — A first-of-its-kind drug for hepatitis B is allowing some patients to cease treatment without showing signs of the dangerous liver virus,
a phenomenon referred to as a “functional cure,” researchers reported Thursday. In two international studies, approximately 1 in 5 patients treated with the experimental drug experienced a reduction in the virus to levels manageable by the immune system.
Dr. Seng Gee Lim of the National University Health System in Singapore, who played a pivotal role in the GSK-funded studies, stated, “We have not had a treatment which has come to this level of cure,” while addressing reporters ahead of presenting the findings at a scientific meeting in Barcelona, Spain.The data from these studies was also published Thursday in the New England Journal of Medicine.
Chronic hepatitis B can lead to severe health issues such as liver cancer or liver failure, resulting in approximately 1.1 million fatalities worldwide each year. For decades, improvements to the current lifelong therapies, which can be difficult to adhere to or access in certain regions, have been sought.
Dr. Anna Lok, a hepatitis expert at the University of Michigan not involved in the research, remarked in the journal that the new findings “represent a major step,” but cautioned that further study is essential to determine the duration of this remission-like state.
The drug, known as bepirovirsen or “bepi,” has been developed by GSK and Ionis Pharmaceuticals and is currently under fast-track review by the U.S. Food and Drug Administration, with a decision anticipated in October. Regulatory bodies in Japan, China, and Europe are also evaluating the drug.
Hepatitis B is a serious liver infection transmitted through contact with blood or bodily fluids, including during childbirth. A highly effective vaccine exists to prevent it. Many infected individuals experience an “acute” illness lasting several months, but for about 1.7 million people in the U.S. and over 250 million globally, it evolves into a chronic condition that progressively harms the liver.
Standard treatments, which include daily pills, lower virus levels and prevent liver damage. However, a true cure remains elusive due to hepatitis B's unique ability to conceal itself in the body, ready to reactivate if therapy is halted.
The new drug targets hepatitis B by attaching to its genetic components, inhibiting viral replication and a critical protein known as the “S” or surface protein, while also stimulating the immune system, according to GSK vice president Melanie Paff.
The trials involved 1,838 patients who were assigned to receive either a bepi injection or a placebo weekly for six months, alongside their standard medications. If the virus remained undetectable for six months after discontinuing the injections, they could also stop their regular medications. Approximately 20% of the bepi recipients maintained undetectable virus levels for an additional six months after ceasing all treatments, achieving that “functional cure,” which was not seen in any patients who received the placebo, the researchers noted.
Lim indicated that bepi recipients who commenced the study with lower levels of the S protein had a slightly higher likelihood of achieving a functional cure. He is conducting further research to explore why only certain individuals respond positively.
Regarding the duration of the functional cure, GSK has been monitoring a small cohort of patients from earlier studies and found that most have continued to do well up to three years later, Paff reported.
Lim mentioned that side effects included mild redness or pain at the injection site and a temporary increase in enzymes that can indicate liver stress.
Lok noted that the trials did not include patients with cirrhosis, elevated S protein levels, or other complicating factors.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
