The U.S. Food and Drug Administration (FDA) has approved a new medication called Hibsago (also known as bepirovirsen) for adults who have chronic hepatitis B. To qualify for this treatment, patients must meet certain viral criteria and have already been taking nucleos(t)ide analogue therapy, a common treatment for hepatitis B, for at least six months. This new drug is the first of its kind to show much higher rates of functional cure compared to the standard treatments currently available.
Tony Wood, who works for the company that makes Hibsago, explained why this approval is important. He said, “Many people with chronic hepatitis B have to stay on their current treatments for life and still face serious risks to their liver, like scarring, liver failure, or even liver cancer.
“For the first time, patients in the U.S. now have a chance to achieve a functional cure after just six months of treatment with Hibsago. After the first dose, patients may even be able to give themselves the injections at home if their doctor approves.”
The FDA’s decision is based on the results of phase 3 B-Well clinical trials, which showed that 19% of adults with lower levels of hepatitis B surface antigen (HBsAg) at the start of the study achieved a functional cure. In comparison, less than 1% of patients using the standard treatments for one year achieve this level of cure. A functional cure means the hepatitis B virus is no longer detectable in the blood, and this result lasts for at least 24 weeks after stopping all treatment.
Dr. Norah Terrault, a liver specialist, shared her thoughts on this breakthrough: “This is the beginning of a new chapter in treating chronic hepatitis B. For a long time, both patients and doctors have hoped for a treatment that could cure hepatitis B after just a short period of time. Hibsago brings us closer to that goal.”
Dr. Chari Cohen, another expert in hepatitis B, emphasized the importance of this approval. She said, “Chronic hepatitis B is a serious health issue that affects millions of people in the U.S. and is responsible for more than half of all global liver cancer cases.
“Today’s approval is a major step forward in how we manage chronic hepatitis B. It means we can do better in screening and diagnosing patients, as well as offering them new and innovative treatment options.”
To help doctors identify which patients are best suited for this new treatment, a blood test called quantitative surface antigen testing will be used. Several FDA-approved tests are already available for this purpose. GSK, the company that developed Hibsago, is also working to get this treatment approved in other countries around the world. Regulatory decisions in those countries are expected soon.