China's first child anti-hepatitis B virus drug approved by CFDA
On August 16, Bristol-Myers Squibb announced that it has obtained oral anti-hepatitis B virus entecavir tablets (Boluding) based on clinical trial data on children's indications that have been completed abroad and long-term clinical observation data on adult indications in China. CFDA approved for the treatment of patients with nucleosides from chronic hepatitis B virus-borne liver disease from 2 years old to 18 years old. This is the first nucleoside drug approved for use in children with hepatitis B (<12 years old) in China. .
Relevant data show that in the past two decades, with the continued popularization and implementation of the hepatitis B vaccination prevention strategy, the prevention and control of hepatitis B in Chinese newborns has achieved remarkable results, and the rate of chronic hepatitis B virus infection among children under 5 has dropped to 1 Below %, however, the current rate of hepatitis B surface antigen carrying in women of childbearing age in China is about 6%, although 90%-95% of children born to surface antigen-positive mothers are free of hepatitis B virus infection by injection of hepatitis B vaccine and hepatitis B immunoglobulin. However, there are still a small number of children born to pregnant women with high viral load of hepatitis B who are infected with hepatitis B virus.
Zhang Hongfei, a professor of the Center for Diagnosis and Treatment of Adolescent Liver Diseases at the 302 Hospital of the People's Liberation Army, said: Children with hepatitis B infection may not be considered for anti-viral treatment when they are in the immune tolerance period; if it is during the active and re-active period, antiviral treatment is needed in time. Otherwise, You will miss the best treatment opportunity. Compared with adults, children with hepatitis B have a higher incidence of chronic disease. Among them, the incidence of chronic hepatitis B virus infection in perinatal and early childhood is 90% and 30%, respectively, and about 3%-5% of children may develop cirrhosis before adulthood.
According to the latest edition of the "Guidelines for the Prevention and Treatment of Hepatitis B" in China, both adult and child chronic hepatitis B patients are treated with the goal of maximally inhibiting hepatitis B virus DNA replication, reducing liver inflammation and necrosis, and greatly reducing progression to cirrhosis. The risk of liver cancer "Although the treatment goals are clear, the antiviral treatment of young children in China has long been faced with the dilemma of less drug use." Zhang Hongfei pointed out that "Boluding is the most effective oral nucleoside for the treatment of hepatitis B children." Antiviral drugs can inhibit the replication of hepatitis B virus in the liver, reduce inflammation and necrosis of liver, reverse liver fibrosis, thereby reducing the risk of liver disease progression to cirrhosis and liver cancer. The approval of children's oral tablet indications has been opened. A new chapter in antiviral treatment for children in China."
In fact, as early as 2005, Boluid was approved in China for the treatment of adult chronic hepatitis B patients with active viral replication, elevated ALT, or active histology of liver histology. In recent years, its effectiveness and safety in children's antiviral therapy has also been confirmed. In 2014, Bolu Ding was approved by the US Food and Drug Administration (FDA) for the treatment of children with hepatitis B 2 years and older on the basis of informed consent. In 2016, Hepatology published a randomized, double-blind, multi-center, phase III clinical trial that showed that HBeAg was first treated with nucleosides from 2 to 18 years old (HBeAg). In children with positive, the proportion of HBV DNA dropped below 50 IU/ml at 48 and 96 weeks was 49% and 64%, and the HBeAg seroconversion was 24% and 37%, respectively. The resistance rate at 96 weeks was 1.3%. At the same time, the safety is good and has no effect on the growth and development of children.
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