EMA committee recommends Harvoni to treat HCV

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommends a marketing authorization application for ledipasvir/sofosbuvir as treatment for chronic hepatitis C virus infection in adults, according to a news release.

The once-daily combination of 90 mg ledipasvir and 400 mg sofosbuvir (Harvoni, Gilead Sciences) currently is an investigational drug, and its safety and efficacy have not been established in the European Union, the Gilead release said.

The CHMP recommendation comes after multiple phase 3 clinical trials, including ION-1, ION-2 and ION-3, generated high sustained virologic response among patients with HCV who received ledipasvir/sofosbuvir with or without ribavirin.

In the ION-2 trial, treatment-experienced patients with HCV genotype 1 received a fixed-dose combination of ledipasvir and sofosbuvir for either 12 or 24 weeks, resulting in 94% and 99% of patients, respectively, achieving SVR.

The European Commission, which has the authority to approve medicines for use in the 28 European Union countries, will review the recommendation, the release said.

The single-agent sofosbuvir (Sovaldi, Gilead Sciences) was granted marketing authorization in the EU in January. It also has been approved for use in the US, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.