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WASHINGTON (AP) — A first-of-its-kind drug for hepatitis B is allowing some patients to stop treatment without showing signs of the dangerous liver virus,
a development researchers have termed a 'functional cure.' 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 from the National University Health System of Singapore, who co-led the GSK-funded studies, remarked, 'We have not had a treatment which has come to this level of cure,' during a presentation of the findings at a scientific meeting in Barcelona, Spain. The data was also published in the New England Journal of Medicine.Chronic hepatitis B, which can lead to liver cancer or failure, claims about 1.1 million lives globally each year. For decades, researchers have sought improvements to the lifelong therapy currently available, which can be challenging to adhere to or access in various regions.
Dr. Anna Lok, a hepatitis expert at the University of Michigan not involved in the research, described the findings as 'a major step' in the journal but emphasized the need for further studies to assess the duration of this remission-like state.
The drug, known as bepirovirsen or 'bepi,' was developed by GSK and Ionis Pharmaceuticals and is currently undergoing 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 is available to prevent it. Many individuals experience an 'acute' illness lasting several months, but for about 1.7 million people in the U.S. and over 250 million worldwide, the infection becomes chronic and progressively harms the liver.
Standard treatments, which often involve daily pills, lower virus levels and avert liver damage. However, achieving a true cure remains elusive due to hepatitis B's unique ability to hide within the body, poised to reemerge if therapy ceases.
The new drug combats hepatitis B by binding to its genetic components, inhibiting viral replication and a crucial protein known as the 'S' or surface protein, while also stimulating the immune system, according to GSK vice president Melanie Paff.
The trials comprised 1,838 patients who received either a bepi injection or a placebo weekly for six months alongside their regular medication. Patients who maintained undetectable virus levels for six months after discontinuing the injections could also stop their standard treatment. Researchers reported that about 20% of those who received bepi sustained undetectable virus levels for an additional six months after ceasing all treatments, achieving what is termed a 'functional cure,' a result not seen in any of the placebo recipients.
Lim noted that bepi recipients who entered the study with lower levels of the S protein were slightly more likely to attain a functional cure. He is conducting further research to understand why only certain individuals respond positively to the treatment.
Regarding the longevity of the functional cure, GSK has monitored a small cohort of patients from earlier studies, finding that most continued to do well up to three years later, according to Paff.
Lim stated that side effects were generally mild, including slight redness or pain at the injection site and a temporary increase in enzymes indicative of liver stress.
Lok, the Michigan expert, pointed out that the trials did not involve patients with cirrhosis, elevated S protein levels, or other complicating factors.
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.
