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Gospel of Chinese patients with hepatitis C, all oral drugs are approved by CFDA

2017-05-03 来源:转载自第三方
3 May 2017
  Recently, Bristol-Myers Squibb announced officially that Daclatasvir and Asunaprevir has been approved by CFDA as the first full oral direct anti-hepatitis C virus combination therapy for the treatment of adult gene type 1b chronic hepatitis C (non-cirrhosis or decompensated cirrhosis).
  According to WHO's new data, about 325 million people worldwide are infected with chronic hepatitis B virus or hepatitis C virus. In 2015, nearly 1.75 million people were newly infected with hepatitis C virus, bringing the total number of hepatitis C infections worldwide to 71 million people. According to the Chinese Medical Association of Hepatology Branch and Infectious Diseases Branch jointly published 2015 version of "Prevention Guide for Hepatitis C", China has about 10 million hepatitis C virus infection, gene type 1b is the most common genotype, accounting for 56.8%. Hepatitis C virus often boarded the body's liver, and spread through blood or blood products, 55%~85% of hepatitis C infection can not rely on autoimmune to remove the virus, which will evolve into chronic hepatitis C. According to data released by the World Health Organization, the risk of cirrhosis is 15%~30% in 20 years, and can be further developed into hepatocellular carcinoma.
  Daclatasvir is the first NS5A inhibitor targeted to the NS5A protein and directly destroys its normal function and exerts antiviral effects. Recent studies have shown that it acts on two processes of hepatitis C virus replication and can rapidly reduce hepatitis C virus RNA; Asunaprevir is a NS3 protease inhibitor, acting on hepatitis C virus protease NS3/4A, and hepatitis C virus NS3 protein binding, thereby inhibiting its activity, play an antiviral effect. Both were not listed in China before.In February of this year, Bristol-Myers Squibb issued the latest results of a phase III clinical registry study of Daclatasvir and Asunaprevir in the treatment of newly diagnosed hepatitis C patients. A study of patients with primate type 1b hepatitis C from mainland China, South Korea, and Russia showed that 92% to 96% of patients treated with Daclatasvir and Asunaprevir for 24 weeks had sustained viral response after 12 weeks (SVR12), (overall population SVR rate ia 92%, the baseline without NS5A resistance-related mutations SVR12 rate is 96%), and the effect is not influenced by the factors that reduce the interferon response, has a good effect and tolerance. The incidence of adverse events was low during 24 weeks of combined therapy, showing good safety tolerance.
  The global anti-hepatitis C study has evolved over the past few years:
  Prior to 2011, the most effective hepatitis C antiviral treatment protocol was recognized as pegylated interferon (PEG-IFNα) combined with ribavirin, and gene type 1 patients had a sustained virological response rate (SVR) of about 40%~50%; in May 2011, the listing of two NS3/4A serine protease inhibitors, Victrelis and Incivek, changed the status of hepatitis C treatment and increased the rate of sustained virological response to 80%, the course of treatment is also expected to be shortened by half; December 6, 2013, the US FDA approved the nucleotide class NS5B polymerase inhibitor sofosbuvir (Sovaldi) from Gilead Sciences, combined with ribavirin to treat gene type 2 of the hepatitis C patients and achieved more than 90% of the persistent virological response, so the first full oral hepatitis C drug is available; October 10, 2014, The listed of Gillard's second-party compound Harvoni showed that the whole oral anti-hepatitis C drugs have become the gold standard for hepatitis C treatment.
  Daclatasvir combined with Asunaprevir as the first full oral, non-interferon and ribavirin, consisting of two direct antiviral drugs, has the advantages of short course of treatment, high cure rate, low side effects and ease of use, and the combination therapy approved in China also marked a new era of hepatitis C treatment in China, providing a new choice for patients with genotype 1b hepatitis C to be cured.
                   AbbVie Submits New Drug Application to U.S. FDA of G/P for the Treatment of All Major Genotypes of Chronic Hepatitis C
Edited by the Editorial Office of Suzhou Yacoo Science Co., Ltd. 



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