FDA expands approval of Complera in HIV-Gilead Sciences

The FDA has approved the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), from Gilead Sciences, for use in certain virologically-suppressed (HIV RNA <50 copies ml) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. approval is supported by clinical data from the phase iii spirit (study 106) clinical trial. in this randomized, open-label study, virologically suppressed patients who were taking multi-tablet hiv therapy containing a ritonavir-boosted protease inhibitor (pi) either switched to complera or remained on their pi-based regimen.>

The study found that after 48 weeks of treatment with Complera, 89 percent (n=283/317) of switch patients had viral load less than 50 copies/mL, compared to 90 percent (143/159) of patients who remained on a PI-regimen for 24 weeks. Complera was well tolerated. The most common side effects in previous clinical studies of Complera were headache, depressive disorders and insomnia (2 percent for all).