Complera regulatory update

FDA approved an sNDA from Gilead for Complera emtricitabine/tenofovir/rilpivirine for use as an alternative regimen for the treatment of HIV-1 infection in certain virologically suppressed (HIV-1 RNA <50 copies/mL) adult patients who are on a stable antiretroviral regimen. Patients switching to Complera should have no history of virologic failure, have suppressed viral load for >=6 months, be on their first or second antiretroviral regimen and have no current or past history of resistance to Complera components. Complera is already approved in the U.S. to treat HIV-1 infection in treatment-naïve adults with HIV-1 RNA <=100,000 copies/mL. The product is a fixed-dose combination of nucleoside reverse transcriptase inhibitor (NRTIs) emtricitabine and tenofovir and the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine. ...