Researchers have revealed promising results for a drug that is the first of its kind in the treatment of Hepatitis B, as it has shown the ability to help some patients stop treatment without the virus reappearing in their bodies.
Two international studies showed that about one in five patients who received the experimental drug bepirovirsen (abbreviated as bepi), developed by the pharmaceutical company GSK in collaboration with Ionis Pharmaceuticals, were able to reduce viral levels to a point where the immune system was able to control it, so that it remained undetectable even after treatment was stopped.
These results came from clinical trials involving 1,838 patients, who were randomly assigned to receive either a weekly injection of the drug or a placebo, in addition to their usual treatment for six months. If the virus remained undetectable for six months after the injections were stopped, the standard treatment could also be discontinued.
The results showed that in about 20% of the patients who received the drug, the virus remained undetectable for six months after the complete cessation of treatment, compared to no functional recovery being recorded in the group that received the placebo.
Chronic hepatitis B is a serious disease that can lead to cirrhosis or liver cancer, and it causes approximately 1.1 million deaths annually worldwide. More than 250 million people globally are living with hepatitis B, including about 1.7 million in the United States.
Although there are current treatments that are effective in controlling the virus and reducing its damage, they require daily use for life and often do not lead to a complete cure, due to the virus's ability to hide inside liver cells.
The new drug works by targeting the virus's genetic material, which inhibits its replication and reduces the surface protein responsible for it, in addition to stimulating the immune system to attack it.
The researchers cautioned that some patients may experience mild side effects such as pain or redness at the injection site, or a temporary increase in liver enzymes. They also noted that the trials did not include complex cases such as advanced cirrhosis.
The researchers stressed that although the results are important, they still need further studies to confirm the continuity of "functional recovery" and to expand it to include wider categories of patients.
In a related context, the drug is currently undergoing an urgent review by the US Food and Drug Administration (FDA), with a decision expected in October. Meanwhile, regulatory bodies in Europe, Japan, and China are considering its approval if its effectiveness and safety are definitively proven.
The results were published in the New England Journal of Medicine and presented at a scientific meeting in Barcelona, Spain.
