A new drug has achieved a “functional cure” in around one in five patients with chronic hepatitis B infection, in what researchers say is the most significant advance in treatment of the disease in decades.
The findings, published in the New England Journal of Medicine, said the drug bepirovirsen could mark a turning point in efforts to control a virus that affects hundreds of millions of people globally and can lead to liver cirrhosis, cancer and death.
“It’s the first major advance in the treatment of chronic hepatitis B in decades,” said Dr William Jarnagin, a liver specialist at Memorial Sloan Kettering Cancer Center.
Hepatitis B is transmitted through infected blood and bodily fluids, including semen. While many adults clear the infection, others develop a chronic form in which the virus persists in liver cells for life.
Although a safe and effective vaccine exists, millions of people globally are living with chronic infection.
Current standard treatments involve lifelong antiviral therapy and drugs designed to strengthen immune response, but these do not eliminate the virus and patients remain at risk of liver cancer.
Bepirovirsen, developed by Ionis Pharmaceuticals and GlaxoSmithKline, is designed to block viral replication and enhance immune clearance of infected cells. It is administered as a weekly injection.
The drug was tested in two 24-week clinical trials involving more than 1,800 patients across 29 countries in Asia, Europe, and North and South America. Participants either received bepirovirsen or a placebo.
Researchers found that about 20 per cent of those treated with bepirovirsen achieved a functional cure, defined as the virus becoming undetectable in the blood and remaining so 48 weeks after treatment ended. No patients in the placebo group achieved this outcome.
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While not considered a complete eradication of the virus, a functional cure is viewed as a major clinical milestone because it can significantly reduce the risk of liver damage and long-term complications.
In an accompanying editorial, Dr Anna S Lok of the University of Michigan described the results as “remarkable”, adding that they “represent a major step forward” in the treatment of chronic hepatitis B.
Experts say further studies are required to determine how durable the response is and which patients are most likely to benefit, but the findings have raised hopes in a field where progress has been limited for decades.
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