The FDA has approved Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate; Gilead Sciences), a single-tablet regimen, for the treatment of HIV-1 infection in treatment-naive adults. This approval was based on 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) that evaluated the safety and efficacy of rilpivirine compared to efavirenz among treatment-naïve HIV-1 infected adults. Both arms of the study were administered with a background regimen, in which the majority of patients in the rilpivirine arm received Truvada. A bioequivalence study demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.
Complera will be available in a 200mg emtricitabine, 25mg rilpivirine, and 300mg tenofovir disoproxil fumarate dosage strength tablet.
For more information call (800) 445-3235 or visit www.gilead.com.