Hepatitis C drug harvoni of Gilead is licensed for marketing in Europe

Source: dxy-2014-11-21 Gilead company has obtained the marketing authorization from the European Commission for harvoni The drug contains 90mg of ledipasvir and 400mg of sofosbuvir, which is the first tablet that can be used to treat most adults with chronic hepatitis C genotype 1 and 4, once a day Harvoni is a combination of ledipasvir (LDV), an NS5A inhibitor, and sofosbuvir (SOF), a nucleotide analogue polymerase inhibitor It can be used to treat chronic hepatitis C virus (HCV) in adults The marketing license is mainly based on three phase 3 clinical trials, ion-1, ion-2 and ion-3, in which harvoni is evaluated to treat nearly 2000 patients with decompensated hepatitis C virus infection and decompensated liver disease with 8 weeks, 12 weeks or 24 weeks' treatment with ribavirin or alone In January 2014, harvoni was approved by the European Commission for sale under the trade name sovaldi Harvoni is recommended for patients with cirrhosis and non cirrhosis genotype 1 and 4 who have not been treated or have been treated According to the past treatment history and the status of cirrhosis, the course of treatment was 12 or 24 weeks Harvoni is recommended for 8 weeks of treatment in patients with non cirrhosis genotype 1 who have not been treated, the company said For genotype 1 and 4 patients with decompensated cirrhosis, and genotype 3 patients with cirrhosis and / or previous treatment failure, harvoni should be used in combination with ribavirin and treated for 24 weeks "In Europe, patients with genotype 1 hepatitis C, as well as their doctors, have been looking forward to such a drug for decades," said foster, a professor of liver disease at Queen Mary's college, University of London "With the emergence of harvoni, we are going to change the way we treat common types of hepatitis C patients in Europe "Now, we can expect very high systemic vascular resistance (SVR), and for many patients, we can no longer need interferon injections and ribavirin, and only take tablets once a day." The EU approval is based on data from the solar-1 trial, which involved patients with refractory decompensated cirrhosis or liver transplantation, and the eradicate trial, which evaluated patients with genotype 1 hepatitis C and preliminary data proving HIV infection.