Good news for hepatitis C! Introduction of liver C cocktail harvoni into Asian market

Source: Gilead, leader of Biovalley's hepatitis C treatment on July 7, 2015, has received good news in Asia recently Harvoni, a new generation of hepatitis C cocktail therapy developed by the company, has been approved by the Ministry of labor, health and welfare of Japan (MHLW) for the treatment of genotype 1 hepatitis C (GT-1 HCV) with or without cirrhosis ）For adult patients, the treatment plan is 12 weeks Harvoni is the world's first daily all oral interferon free hepatitis C cocktail therapy, completely eliminating ribavirin (RBV) and interferon injection drug, which will become the gold standard for clinical treatment of hepatitis C Previously, harvoni was approved by FDA and EMA in October and November 2014 respectively This approval marks harvoni's official entry into the Asian market The drug provides a safe, simple, well tolerated treatment scheme with a cure rate of up to 100% It will greatly simplify the clinical treatment of genotype 1 hepatitis C patients and greatly improve the possibility of patients' cure The Japanese market is very important for gilid, which has the highest incidence rate of liver cancer in all industrialized countries, mainly due to chronic hepatitis C virus (HCV) infection In Japan, there are more than 1 million hepatitis C patients, 70% - 80% of whom are infected with genotype 1 HCV strain The current standard treatment for genotype 1 HCV infection in the country involves injection of pegylated interferon, oral ribavirin (RBV) and other drugs for up to 48 weeks, which may not be suitable for some specific patients Harvoni (ledipasvir / sofosbuvir, 90mg / 400mg) is composed of Geely's star drug of hepatitis C, sofosbuvir (SOF), and an experimental NS5A blocker, ledipasvir (LDV) In phase III clinical treatment, the clinical cure rate (svr12) of harvoni 8-12 week treatment is 94% - 99% Sovaldi, a nucleoside polymerase inhibitor, was approved by Japan in March 2015 for the treatment of genotype 2 hepatitis C Harvoni's approval in Japan is based on the top line data of gs-us-337-0113, a phase III study conducted in patients with hepatitis C in Japan The study involved 318 patients with primary or treated genotype 1 hepatitis C, 34% of whom were 65 years old and over, and 23% with cirrhosis In the study, patients were randomly assigned to LDV / sof (n = 157) or LDV / sof / RBV (n = 161) Data showed that 12 weeks after LDV / sof treatment, svr12 was achieved in both the primary treatment group (n = 78 / 78) and the treatment group (n = 79 / 79), and the cure rate of hepatitis C group with cirrhosis (n = 75 / 76) was 99% In addition, harvoni's approval was supported by data from three other phase III studies (ion-1, - 2, - 3) These three studies were carried out in patients with genotype 1 hepatitis C, involving patients with hepatitis C in the United States, Europe and Puerto Rico who were initially treated, treated and accompanied by cirrhosis The efficacy and safety of LDV / sof treatment regimens for 8, 12 and 24 weeks were evaluated respectively The data showed that the clinical cure rate (svr12) of LDV / sof (RBV) 12 week treatment was 94% - 99%.