Gilead Sciences has announced that the European Commission has granted a marketing authorisation for Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults.
This therapy combines the NS5A inhibitor ledipasvir (LDV) with the nucleotide analog polymerase inhibitor sofosbuvir (SOF), licenced by the European Commission under the tradename Sovaldi in January 2014.
Ledipasvir/sofosbuvir is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and is recommended in treatment-naïve and treatment-experienced cirrhotic and non-cirrhotic genotype 1 and 4 patients with a treatment duration of 12 or 24 weeks depending on prior treatment history and cirrhosis status. Eight weeks of treatment with ledipasvir/sofosbuvir may be considered in non-cirrhotic treatment-naïve genotype 1 patients. In genotype 1 and 4 patients with decompensated cirrhosis, and genotype 3 patients with cirrhosis and/or prior treatment failure, ledipasvir/sofosbuvir should be used in combination with ribavirin for 24 weeks. Ledipasvir/sofosbuvir is also indicated for patients with HCV who have HIV co-infection.1
“Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for further treatment advances,” said Graham Foster, Professor of Hepatology, Queen Mary University of London. “With Harvoni, we have the potential to change the way we treat people living with the most prevalent form of hepatitis C in Europe.”
