June 25, 2024

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Nucleic acid drugs can achieve functional cure of hepatitis B

Nucleic acid drugs can achieve functional cure of hepatitis B


Nucleic acid drugs can achieve functional cure of hepatitis B.

Hepatitis B, caused by hepatitis B virus (HBV) infection, is a major threat to global public health. Worldwide, more than 300 million people are currently infected with hepatitis B virus, and about 600,000 people die each year from liver disease or liver cancer caused by hepatitis B virus. 


Current treatments for chronic hepatitis B include nucleoside analogs (inhibiting viral replication) and interferon (enhancing the immune system) , etc., but these are difficult to achieve functional cure. Combining the two, only a very small number of patients can achieve functional Sexual Healing.

Functional cure of hepatitis B refers to maintaining HBsAg (hepatitis B surface antigen) negative after stopping treatment, undetectable hepatitis B virus DNA, normal liver biochemical indicators, and improvement of liver tissue lesions.


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Recently, pharmaceutical giant GlaxoSmithKline (GSK) announced interim data from a Phase 2b clinical trial of its antisense oligonucleotide (ASO) drug bepirovirsen for the treatment of hepatitis B at the 2022 International Liver Congress.

The data showed that after 24 weeks of treatment, nearly 30% of HBV patients had undetectable levels of HBV in their bodies, marking a major step forward for GSK to provide a functional cure for HBV patients.


Nucleoside/nucleoside analogs are the first-line treatment for HBV patients, and they inhibit HBV replication.

However, it cannot clear the hepatitis B virus, so it must be taken continuously for life. The unique design of bepirovirsen aims to reduce the replication of hepatitis B virus and inhibit the production of HBsAg, thereby achieving a functional cure and freeing patients from lifelong medication.


Bepirovirsen was originally developed by Ionis Pharmaceuticals , an RNA-targeted therapy company , and in 2019, GSK paid $25 million upfront to collaborate with Ionis on subsequent development.



Specifically, this clinical trial was designed to evaluate the safety and efficacy bepirovirsen in hepatitis B patients receiving standard nucleoside therapy and not receiving standard nucleoside analog therapy .

The results show:

  • For hepatitis B patients (227 people) receiving nucleoside analog therapy , bepirovirsen 300mg weekly for 24 weeks, 28% of patients achieved HBsAg (hepatitis B surface antigen) and hepatitis B virus DNA detection at the end of treatment. less than level;
  • For hepatitis B patients who did not receive nucleoside analog therapy (230 people) , 300 mg of bepirovirsen weekly for 24 weeks, of which 29% of patients achieved HBsAg (hepatitis B surface antigen) and hepatitis B virus DNA at the end of treatment. undetectable levels;
  • The durability of these therapeutic effects is still a work in progress.


GSK is also exploring the use of bepirovirsen in combination with other therapies, such as peginterferon, targeted immunotherapy, etc., hoping to help the remaining 70% of hepatitis B patients achieve functional cure.


Overall, the interim data from this Phase 2b clinical trial, together with previous clinical results, support GSK’s initiation of a Phase 3 clinical program for bepirovirsen in the treatment of hepatitis B.


It is worth mentioning that the domestic company Ruibo Bio is also researching nucleic acid drugs for the treatment of hepatitis B. In February 2022, Ruibo Bio published a paper entitled: Ionizable liposomal siRNA therapeutics enables potent and persistent treatment in the journal Signal Transduction and Targeted Therapy . of Hepatitis B research paper.


This study developed a novel ionizable lipid nanoparticle , RBP131 , that specifically entered liver cells by targeting apolipoprotein B (APOB) and used it to deliver modified siRNA targeting the HBV genome.


The results of animal experiments showed that the siRNA delivered by RBP131 could effectively inhibit the HBV RNA and antigens (HBsAg, HBeAg) and HBV DNA in the circulating system and liver tissue. This provides a promising therapeutic approach for functional cure of chronic hepatitis B.








References :

Nucleic acid drugs can achieve functional cure of hepatitis B

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