Washington: The US Food and Drug Administration (FDA) has approved a new drug ‘Hibsago’ (bepirovirsen) for the treatment of chronic hepatitis B. It is an injectable drug, allowing some eligible patients to keep the virus under control even after discontinuing regular antiviral medications. However, this treatment is not effective for all patients and there are many serious risks in its use.
Hibsago, developed by drugmaker GSK, has been approved for adult patients who have chronic hepatitis B but not liver cirrhosis. According to the FDA, it is the first antisense oligonucleotide drug to be approved for the treatment of hepatitis B. This technique is designed to disrupt the genetic instructions used in the reproduction of viruses and the formation of viral proteins.
Wendy Carter, acting director of the FDA’s Office of Infectious Diseases, said that many people with chronic hepatitis B have to take antiviral medications for years to keep the virus under control. Hibsago offers a new treatment option that allows some patients to keep the virus under control even after discontinuing all hepatitis B medications, he said.
This approval is for adult patients who do not have cirrhosis, who have been taking antiviral treatment for at least six months and who have controlled levels of hepatitis B virus in their blood. In addition, the level of hepatitis B surface antigen in their blood should be 3,000 international units per milliliter or less. This will be confirmed through an FDA-authorized investigation.
The effectiveness of the drug was assessed in two clinical trials in which it was compared to placebo. In the trial, patients were given injections of Hibsago under the skin for 24 weeks. During this time, he also continued to take his regular antiviral medications. After the last injection, he had to continue his old antiviral treatment for at least 24 weeks.
Subsequently, some patients who met the prescribed medical and laboratory criteria were allowed to discontinue antiviral drugs. Combining the two trials, 24 per cent of the patients taking Hibsago met the prescribed criteria for discontinuation of their regular antiviral drugs, compared to none in the placebo group.
After 24 weeks of discontinuation of all hepatitis B treatments, 19 percent of patients who took Hibsago had control of the virus and no hepatitis B surface antigen was detected in their blood. However, the results show that most patients did not succeed in reaching this level. Therefore, the possibility of keeping the virus under control for a long time without regular treatment with the drug was seen only in some patients.
The FDA has also warned about the serious health risks associated with the drug. Instructions for its use include warnings of serious side effects on the liver and low platelet count. Low platelets can increase the risk of life-threatening bleeding.
In addition, complications associated with deterioration of kidney function, severe reactions such as swelling of blood vessels, and disturbances in the drug administration process are also warned. Regular blood tests and medical monitoring of patients will be necessary before and during treatment.
Reaction at the injection site, fever, fatigue, and headache are among the commonly reported side effects. The FDA has also approved an adjuvant test developed by Roche to help identify eligible patients and monitor treatment.
Hibsago was also recognized under categories such as Fast Track, Breakthrough Therapy, and Priority Review. These arrangements are meant to expedite the review of treatments that may have the potential to address a significant medical need.
The approval has been given to GSK plc. However, the FDA’s announcement did not specify the date of commercial availability of the drug outside the US, especially in India.
Chronic hepatitis B is a long-term viral infection that affects the liver. Many patients have to take antiviral medications for a long time to suppress the virus and reduce the risk of complications such as cirrhosis and liver cancer. It is also a major public health challenge in India including Asia. Access to vaccinations, screenings, and treatments are crucial for its prevention and control.
[DD news]