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Entecavir has been approved by CFDA for children

2017-08-22 来源:转载自第三方
22 August 2017
  Recently, Entecavir Tablet (Baraclude), developed by Bristol-Myers Squibb (BMS), has been approved by the CFDA for the treatment of patients from 2 to 18 years old with chronic hepatitis B virus infected compensatory liver disease.
  Hepatitis B is a kind of infectious disease caused by the hepatitis B virus, which targets the liver and can cause a variety of organ damage, it is mainly transmitted by blood. The popularity of hepatitis B vaccine has made HBsAg carrying rate in our general population fall to 4.38%, but because of the large population base, there are still about 28 million chronic hepatitis B patients, among this, there are a considerable number of children. Children with hepatitis B are mostly due to the high viral load of the mother during pregnancy, if not treated in time, it will have a serious impact on the child's growth and future life: about 3%~5% of children will develop into cirrhosis before adulthood, 0.01%~0.03% may even develop into liver cancer.
  In the treatment of chronic hepatitis B, there are five kinds in two categories in China recognized by experts, including, interferon (common interferon, long-acting interferon) and nucleosides (lamivudine, adefovir, entecavir). And these drugs are for adult patients, for young children, China has been in the dilemma of available drugs.
  As early as 2005, entecavir (Baraclude) was approved for the treatment of patients with chronic hepatitis B who were active in viral replication, elevated ALT or had liver histology active lesions. Its early response rate is up to 90% or more, medication 2 years did not occur drug resistance, it has less adverse reactions and good safety for long-term use. In recent years, the effectiveness and safety of the drug in children's antiviral therapy have been confirmed:
In 2014, Baraclude was approved by the FDA and used for the treatment of children in 2 and over with hepatitis B on the basis of fully informed consent. In 2016, its phase III clinical trials were published by journal Hepatology, which showed that the treatment effect for children in 2 to 18 years old is good, and the resistance rate is low. There is no effect on the growth and development of children.
Entecavir has been approved by CFDA for children
  Entecavir is the first oral nucleoside antiviral drug approved for the treatment of chronic hepatitis B in children. It is also the most effective drug for the treatment of chronic hepatitis B in children. It not only brings hope for improving the quality of life, but also will change the fate of many children with hepatitis B.
Edited by Suzhou Yacoo Science Co., Ltd.