- Harvoni is a dual therapy that supplements the active ingredient in Sovaldi (sofosbuvir) with the new compound ledipasvir, and thus eliminates the need to concurrently treat patients using Sovaldi with interferon and ribavarin. It is a once-daily, single oral pill.
- The EU approval is based on data from several large phase III trials that included various patients' groups.
- Harvoni was approved in the U.S. and in Canada in 2014.
Studies that support Harvoni's EU approval included patients who were treatment experienced and treatment naive, as well as patients with and without cirrhosis. Some regimens included interferon or a protease inhibitor, while others involved Harvoni alone.
Patients who had already experienced liver failure or had HIV were also included. Overall, sustained virologic response (SVR, meaning no detectable virus) rates were sustained in 12 weeks or more—the threshold for treatment success—in 94% to 98% of all patients.
With this newest market approval, Harvoni is set (as expected) to become a true worldwide blockbuster. On top of U.S. and EU approvals, Gilead is working out deals to sell cheaper genericized versions of the drug to poorer nations, making the hep C treatment a locked-in global giant in this treatment category.