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Inventory of imported hepatitis C DAA drugs approved in China

2017-11-08 来源:转载自第三方
8 November 2017

  Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), which may later develop into cirrhosis and liver cancer. Most domestic patients receive interferon-based treatment regimens, with a low cure rate and many adverse reactions. Direct antiviral agents (DAA) has become the main force of hepatitis C treatment because of its safety and high cure rate, and domestic hepatitis C treatment has begun to gradually enter the DAA era. Here's a list of domestic DAA imported drugs.
Bertrix®(daclatasvir hydrochloride tablets) and Velovir® (asunaprevir capsules)
  In April this year, Bertrix®(daclatasvir hydrochloride tablets) and Velovir® (asunaprevir capsules) from Bristol-Myers Squibb were approved by the CFDA as the first all-oral direct anti-hepatitis C virus combination treatment for adult genotype 1b chronic hepatitis C (non-cirrhosis or compensated cirrhosis).
  Daclatasvir hydrochloride is an NS5A inhibitor that targets NS5A protein and directly disrupts its normal function. Asunaprevir is an NS3 protease inhibitor that binds to the hepatitis C virus NS3 protein and thus inhibits its activity. According to clinical research results, the cure rate of combination of the two programs for the gene type 1b chronic hepatitis C is 91%~99%, and has good safety and tolerability.
  In August, Johnson & Johnson's Simeprevir was approved by the CFDA for use in combination with pegylated interferon and ribavirin for decompensated liver disease (including cirrhosis) in adults with genotype 1 chronic hepatitis C.
  Simeprevir is a new generation of NS3/4A protease inhibitors that work by inhibiting proteases in HCV to inhibit HCV replication in liver cells. Administration: simeprevir+pegylated interferon+ribavirin combination therapy for 12 weeks, followed by pegylated interferon+ribavirin treatment for 12 weeks or 36 weeks, making the viral response rate of the relatively refractory genotype 1 in hepatitis C patients increased from 40% to over 90%.
Ombitasvir and Dasabuvir
  In September, Abbvie's Ombitasvir in combination with Dasabuvir was approved by CFDA for the treatment of adult genotype 1 chronic hepatitis C, including liverless sclerosis or patients with compensated cirrhosis.
  Ombitasvir is a compound preparation consisting of 12.5mg of ombitasvir, 75mg of Paritaprevir and 50mg of ritonavir. The combination regimen is fully oral, interferon-free, with or without ribavirin. The program contains three direct antiviral drugs, NS5A inhibitors, NS3/4A protease inhibitors, and NS5B polymerase non-nucleoside analogue inhibitors that target the three major targets of the hepatitis C virus and inhibit the replication of hepatitis C virus . A number of clinical studies have shown that, nearly 100% sustained virus response rate was achieved in 12 weeks for treatment of Chinese patients with genotype 1b chronic hepatitis C.
Sovaldi (Sofosbuvir)
  In September, Gilead's Sovaldi (Sofosbuvir) was approved by the CFDA for use in combination with other drugs for oral administration once daily to treat adults and teenagers aged 12 to 18 years with genotype C Hepatitis virus infection.
  Sofosbuvir is a NS5B polymerase inhibitor. Data from Phase III clinical studies conducted in China show that for patients with hepatitis C infected with hepatitis C virus genotypes 1, 2, 3 and 6, 12 weeks continuous response rate is 92%~100%. In terms of safety, the most common adverse reactions are blood system abnormalities and fever.
  DAA drugs not only have high cure rate, good safety, short course of treatment and convenient taking, at the same time, they can relieve the degree of fatigue of hepatitis C patients, improve the quality of life and even achieve the goal of cure. Looking forward to the domestic breakthrough in the field of hepatitis C treatment, and benefit patients in China and all around the world.
Edited by Suzhou Yacoo Science Co., Ltd.