Historical milestone in hepatitis B treatment: FDA approved the first functional drug

One of the most important clinical victories in the history of medicine was won against Chronic Hepatitis B (CHB), a disease that kills more than 1 million people worldwide every year and is considered one of the main causes of liver cancer. The US Food and Drug Administration (FDA) approved the drug called "Hibsago", which was developed by the international pharmaceutical company GSK and contains the active ingredient "bepirovirsen".

Traditional Hepatitis B treatments required patients to take lifelong antiviral pills to keep the virus under control. However, the new approved treatment protocol completely eliminates the presence of the virus in the bloodstream with a short 6-month injection course.

In the large-scale Phase 3 clinical trial conducted on 1,220 patients, it was observed that the virus was permanently deleted in 19 percent of the patients who completed the 6-month weekly injection treatment and could not be detected again for 24 weeks after the treatment was terminated. The fact that patients can apply the treatment themselves after the first dose stands out as a great ease of access in the process.

Chronic Hepatitis B virus, which is responsible for approximately 56 percent of liver cancer cases globally, is also among the main causes of liver cirrhosis and organ failure. Prof., one of the experts at the Keck Medical Center of the University of Southern California. Dr. Norah Terrault emphasized that the development started a new era in the history of medicine and stated that for the first time, patients had the chance to get rid of lifelong drug addiction.

FDA officials noted that the new treatment has achieved much higher success rates, especially in patients with low initial viral load, and that the chance of success can be predicted with protein tests before prescribing the drug.

Despite the revolutionary results obtained, the FDA warns that the drug carries the risk of triggering serious side effects such as liver inflammation. It is emphasized that the liver enzymes of patients during the treatment process should be regularly monitored with routine blood analysis.

While scientists continue their clinical research to monitor whether the virus is completely cleared and whether the protection will last for many years, the aim is to increase the success rate of the drug to much more than 19 percent by combining it with other antiviral molecules.