Experimental Hepatitis B Drug Shows Functional Cure in Clinical Trials
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An experimental drug for hepatitis B, bepirovirsen, allowed approximately 20% of trial participants to stop all treatment without signs of the virus, achieving a 'functional cure'. The U.S. Food and Drug Administration (FDA) is conducting a fast-track review of the drug, with a decision expected in October.
Facts First
- Approximately 20% of trial participants achieved a functional cure after six months of weekly injections, allowing them to stop all treatment.
- The U.S. FDA is conducting a fast-track review of the drug, bepirovirsen, with a decision expected in October.
- Chronic hepatitis B causes about 1.1 million deaths annually worldwide and can lead to liver cancer or failure.
- The drug was developed by GSK and Ionis Pharmaceuticals and works by suppressing viral replication and stimulating the immune system.
- Side effects reported were mild, including injection-site redness and a temporary rise in liver enzymes.
What Happened
Researchers reported that a first-of-its-kind drug for hepatitis B, bepirovirsen, allowed some patients to stop treatment without showing signs of the virus, a state called a 'functional cure'. Two international studies funded by GSK showed that approximately 1 in 5 patients receiving the experimental drug saw their virus reduced to levels low enough for the immune system to control. The study data was published on Thursday in the New England Journal of Medicine.
Why this Matters to You
If you or someone you know has chronic hepatitis B, this development may offer a new path to stopping daily medication. The drug could potentially reduce the long-term risk of liver cancer or failure, which are major complications of the disease. For the approximately 1.7 million people in the U.S. with chronic hepatitis B, access to this treatment could change their daily management of the condition.
What's Next
The U.S. Food and Drug Administration (FDA) is conducting a fast-track review of bepirovirsen, with a decision expected in October. Regulators in Japan, China, and Europe are also considering the drug. GSK has tracked a small number of patients from earlier-stage studies and found most were still doing well up to three years later, suggesting the functional cure may be durable.