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EMA validates Gilead's marketing application for ledipasvir/sofosbuvir

Gilead Sciences announced that the company’s Marketing Authorization Application,MAA, for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir, LDV, 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir, SOF, 400 mg for the treatment of chronic hepatitis C virus, HCV, genotype 1 infection, has been fully validated and is now under assessment by the European Medicines Agency, EMA. The data included in the application, which was submitted on February 27, 2014, support the use of LDV/SOF among adult patients with genotype 1 HCV infection for eight or 12 weeks, depending on prior treatment history and whether they have cirrhosis. Genotype 1 is the most prevalent form of HCV in Europe, and accounts for 60 percent of infections worldwide. Current treatments for genotype 1 HCV include pegylated interferon and ribavirin, RBV, which may not be suitable for certain patients.