FDA Approves Gilead Sciences' Complera for HIV-1 Infection in Treatment-Naïve Adults

Gilead Sciences, Inc. GILD today announced that the U.S. Food and Drug Administration has approved Complera, a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. Complera combines three antiretroviral medications in one daily tablet – Gilead's Truvada®, which is a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate, and Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor, rilpivirine. Truvada and rilpivirine were approved by the FDA in August 2004 and May 2011, respectively, for use as part of HIV combination therapy.