CHMP recommends compassionate use of sofosbuvir + ledipasvir combination for Hepatitis C - Gilead Sciences

The CHMP has given an opinion on the use of a fixed-dose combination of ledipasvir and sofosbuvir from Gilead Sciences in the treatment of chronic (long-term) Hepatitis C virus (HCV) infection in a compassionate-use programme. Compassionate-use programmes are set up at the level of individual Member States. They are intended to give patients with a life-threatening, long-lasting or seriously disabling disease with no available treatment options access to treatments that are still under development and that have not yet received a marketing authorisation. In this specific case, Sweden requested an opinion from the CHMP on the conditions under which early access through compassionate use could be given to a combination of ledipasvir and sofosbuvir, with or without ribavirin, for adult patients with genotype 1 HCV infection and advanced liver disease, who are at a high risk of their liver being no longer able to function normally (decompensation) or death within 12 months if left untreated.