An experimental drug for hepatitis B, known as bepirovirsen or “bepi,” is showing promise in providing a functional cure for a subset of patients. In recent international studies, about 20% of patients treated with this drug achieved virus levels low enough for their immune systems to manage without continuous treatment. This development marks a significant advancement in the fight against hepatitis B, a chronic liver infection that can lead to severe health issues such as liver cancer or failure.
Breakthrough in Hepatitis B Treatment
The studies, funded by GSK and conducted with the National University Health System of Singapore, were presented at a scientific meeting in Barcelona, Spain, and published in the New England Journal of Medicine. Dr. Seng Gee Lim, a leading researcher in the study, emphasized the unprecedented level of cure achieved with this treatment. The drug is currently under fast-track review by the U.S. Food and Drug Administration, with a decision expected in October, and is also being considered by regulators in Japan, China, and Europe.
Chronic hepatitis B affects approximately 1.7 million people in the U.S. and over 250 million worldwide. Current treatments involve lifelong therapy, which can be challenging to maintain and access, especially in certain countries. The new drug works by binding to the virus’s genetic components, suppressing replication and stimulating the immune system, according to GSK vice president Melanie Paff.
Study Findings and Future Implications
The trials involved 1,838 patients who received either a weekly injection of bepi or a placebo, alongside their regular medication, for six months. Those who maintained undetectable virus levels for six months after stopping the injections were able to discontinue their regular medication as well. The results showed that about 20% of those receiving bepi achieved this “functional cure,” a milestone not reached by any patients in the placebo group.
Dr. Anna Lok, a hepatitis expert from the University of Michigan, noted the significance of these findings but cautioned that further research is needed to determine the longevity of the remission. Side effects reported were generally mild, including injection-site redness and temporary liver enzyme elevations.
While the trials did not include patients with cirrhosis or high levels of the hepatitis B surface protein, the results are promising for those affected by this chronic condition. The ongoing research aims to understand why only some patients respond to the treatment and how long the benefits last.
Original reporting: KTBS 3 (Shreveport) — read the source article.
