GSK oligonucleotide therapy has been approved clinically or "functionally cured" chronic hepatitis B for the first time in China.

Screenshot Source: CDE Official Website Hepatitis B virus (HBV) infection is the most common serious liver infection in the world.
current nucleotide/nucleotide analogophobic (NUCs) antiviral therapy can inhibit the replication of HBV, but patients need to take medication for life.
The reason is that when the hepatitis B virus enters the host body, it integrates its genome into the nucleus of the host cell to produce co-priced closed ring DNA (cccDNA) and integration sequences, which have a very long half-life, and existing drugs can only reduce HBsAg and viral DNA levels, and it is difficult to completely remove cccDNA.
, achieving a "functional cure" for hepatitis B has become a goal scientists are chasing.
GSK press release, functional cure means that the virus is not completely eliminated but the level is low and can be controlled by the immune system without the need for medication.
GSK3228836 (GSK'836) is an antisant oligonucleotide drug developed jointly by GSK and Ionis Pharmaceuticals.
antonym oligonucleotide is a small, synthetic single-stranded nucleic acid polymer with different chemical properties, which can regulate gene expression through a variety of mechanisms.
In livers infected with HBV, GSK3228836 specifically identifies the mRNA that HBV is used to form viral antigens (the protein that causes disease) and digests the virus mRNA by collecting enzymes from the liver itself, reducing the level of the viral protein HBsAg.
, GSK3228836 has entered phase 2 clinical trials.
is the first time the drug has been approved clinically in China, targeting the "chronic hepatitis B" for the adaptation.
GSK has achieved positive results in Phase 2a clinical trials for patients with chronic hepatitis B, according to data presented at the European Society for Liver Research (EASL) Liver Conference at the end of August.
test results showed that in patients treated at GSK3228836 at a dose of 300 mg, hepatitis B surface antigen levels were higher in patients who had previously been treated with nucleotide analogs (NA) and who had not received NA treatment. There was a decrease: in 4 patients who had received NA treatment, patients who received ASO therapy had a decrease of 2.51 log10 in surface antigen levels compared to placebo, of which 3 patients had a reduction of more than 3 log10; In 12 patients who had not received NA treatment, the level of hepatitis B surface antigen decreased by 1.56 log10 (p-0.001).
three of the patients had a reduction of more than 3 log10.
HBV DNA levels decreased by an average of 1.66 log10 (p.lt;0.001).
data from two patient groups, a total of 4 patients at the end of the 4-week course of treatment hepatitis B surface antigen levels were reduced below detection sensitivity.
, the level of hepatitis B surface antigens continued to decrease in one patient who had not received NA treatment and one patient who had been treated with NA (up to 126 days after follow-up).
GSK said in a press release that the findings mark a potential step toward assessing the goal of a continuous functional cure in patients with chronic hepatitis B.
GSK is expected to conduct phase 2b clinical trials of GSK3228836 by the end of this year.
the World Health Organization (WHO) estimates that there are more than 290 million people with chronic hepatitis B worldwide.
it kills more than 800,000 patients each year.
in China, nearly 100 million people have been infected with HBV, including more than 28 million people with chronic hepatitis B.
HBV infection is the leading cause of liver cancer, which is the second leading cause of cancer death in the world.
source: Medical Mission Hills.