FDA Approves New Treatment for Chronic Hepatitis B, Offering Hope for Patients

Washington, October 21 (Daily Kiran) : The U.S. Food and Drug Administration (FDA) has granted approval for a new treatment for chronic hepatitis B, which may allow some patients to stop taking antiviral medications while still controlling the virus. Announced on October 21, this innovative therapy, known as Hibasago (bepirovirsen), is developed by GSK and is specifically designed for adults without cirrhosis.

Hibasago is the first “antisense oligonucleotide” approved by the FDA for hepatitis B. This therapy employs a unique technique that interferes with the genetic instructions the virus uses to replicate and produce viral proteins. As a result, some patients may maintain viral control even after discontinuing hepatitis B treatment.

Wendy Carter, the acting director of the FDA’s Office of Infectious Diseases, noted, “Many individuals suffering from chronic hepatitis B have to take antiviral medications for years to keep the virus suppressed.” She emphasized that Hibasago offers a novel approach, enabling some patients to manage the virus effectively after completing their treatment, marking significant progress in combating this serious illness.

The approval targets adults without cirrhosis who have undergone at least six months of antiviral therapy and have low levels of the hepatitis B virus in their blood. A diagnostic test authorized by the FDA must confirm that the hepatitis B surface antigen level in the patient’s body is at or below 3,000 international units per milliliter.

The evaluation of this treatment was conducted through two clinical trials comparing Hibasago with a placebo. Participants received injections for 24 weeks while continuing their existing antiviral medications. Following the final injection, they were required to maintain their antiviral treatment for at least another 24 weeks. Some participants were later allowed to stop antiviral medications, provided they met specific medical and laboratory criteria.

In both trials, 24% of patients receiving Hibasago successfully met the conditions to discontinue their antiviral therapy, while no patients in the placebo group achieved this. Remarkably, 19% of those treated with Hibasago maintained viral control and showed no detectable hepatitis B surface antigen in their blood even 24 weeks after stopping all treatment.

These results indicate that some patients may sustain long-term viral control without continuous treatment, although this is not the case for most individuals. The FDA has highlighted that there are significant safety risks associated with this medication.

Warnings in the drug information include serious liver reactions and decreased platelet counts, which could heighten the risk of life-threatening bleeding. Additionally, there are alerts regarding potential kidney dysfunction, severe inflammation (such as vasculitis), and complications from improper administration.

Patients receiving this therapy must undergo regular blood tests before and during treatment and remain under medical supervision. Common side effects include injection site reactions, fever, fatigue, and headaches, alongside any abnormalities detected in lab tests.

The FDA also approved a diagnostic test developed by Roche to aid in identifying suitable patients and monitoring treatment effectiveness. This new drug has been designated as “Fast Track,” “Breakthrough Therapy,” and “Priority Review,” indicating its potential to address a significant medical need.

While the approval has been granted to GSK PLC, the FDA announcement did not specify when this treatment will be commercially available outside the U.S., including in countries like India.

Chronic hepatitis B is a long-lasting viral infection that affects the liver. Many patients require prolonged antiviral therapy to suppress the virus and reduce the risk of complications such as cirrhosis and liver cancer. In Asia, including India, hepatitis B remains a major public health challenge, making prevention, vaccination, screening, and access to treatment essential for managing the disease.