Experimental drug offers potential ‘functional cure’ for hepatitis B
A first-of-its-kind drug for hepatitis B is allowing some patients to stop treatment without showing signs of the dangerous liver virus, referred to as a “functional cure,” researchers reported Thursday, reports BritPanorama.
In two international studies, approximately 20% of patients administered the experimental drug had their virus levels reduced to a point where their immune systems could maintain control without ongoing treatment. This significant finding highlights a new avenue for improving patient care in managing chronic hepatitis B.
“We have not had a treatment which has come to this level of cure,” stated Dr. Seng Gee Lim from the National University Health System of Singapore, who played a key role in the GSK-funded studies presented at a scientific meeting in Barcelona, Spain. The findings were also published in the New England Journal of Medicine.
Chronic hepatitis B can lead to severe complications such as liver cancer or liver failure, causing about 1.1 million deaths globally each year. Current lifelong therapies can be challenging to adhere to and access in various countries, necessitating advances such as those presented.
The new findings represent a pivotal moment in hepatitis research, as highlighted by Dr. Anna Lok, a hepatitis expert at the University of Michigan, who was not involved in the research. She emphasized the need for further studies to determine the longevity of the remission-like state observed in trial participants.
The drug, known as bepirovirsen—referred to as “bepi”—was developed by GSK and Ionis Pharmaceuticals and is 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 its approval.
Hepatitis B is a serious liver infection transmitted through blood or bodily fluids, with more than 250 million people worldwide affected by its chronic form, which progressively harms the liver. While a vaccine can prevent the infection, those infected often experience an acute illness that can evolve into chronic disease, complicating treatment efforts.
Standard treatments, usually involving daily pills, lower virus levels and prevent liver damage, but a definitive cure had remained elusive due to hepatitis B’s unique ability to persist in the body. The new drug tackles hepatitis B by targeting its genetic components, inhibiting viral replication and associated proteins while simultaneously stimulating the immune response.
In the trials, involving 1,838 patients, participants received either a bepi injection or a placebo weekly over six months. Those whose virus became undetectable for six months post-treatment were able to stop their regular medications. Researchers reported that approximately 20% of the bepi recipients maintained an undetectable virus for an additional six months after ceasing all treatments, achieving the purported “functional cure.”
Patients who entered the study with lower levels of the S protein exhibited a higher likelihood of achieving the functional cure, according to Lim, who is conducting additional research to understand variances in response among individuals.
GSK has traced a limited number of patients from earlier studies and noted that most remained well up to three years post-treatment cessation. Side effects from the drug were generally mild, including temporary redness or pain at the injection site, as well as modest increases in liver enzymes.
It is worth noting that the trial participants did not include those with cirrhosis or elevated S protein levels, which may affect outcomes. As research progresses, the implications of these findings on global public health could be extensive, reflecting a promising step toward better management of a historically challenging chronic infection.
As the medical community anticipates further insights into the drug’s long-term efficacy, the opportunity for a significant breakthrough in hepatitis B treatment remains on the horizon.
