Gilead Sciences announced that the FDA has approved Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a single tablet HIV-1 regimen 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.
The approval was based on data from the Phase 3 SPIRIT (Study 106) clinical trial, a randomized, open-label study in virologically suppressed patients who were taking multi-tablet HIV therapy containing a ritonavir-boosted protease inhibitor (PI) who either switched to Complera or remained on their PI-based regimen. The study showed that, after 48 weeks of treatment with Complera, 89% (n=283/317) of switch patients had viral load <50 copies/mL, compared to 90% (143/159) of patients who remained on a PI-regimen for 24 weeks.
Complera is already approved for use as a complete regimen to treat HIV-1 infection in antiretroviral treatment-naive adults with HIV-1 RNA ≤100,000 copies/mL at the start of therapy. The product combines Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate), which itself is a fixed-dose combination of two HIV medicines, with rilpivirine (Edurant; Janssen Therapeutics).
Complera contains emtricitabine 200mg, rilpivirine 25mg, and tenofovir disoproxil fumarate 300mg per tablet.
For more information call (800) GILEAD-5 or visit Gilead.com.