Gilead Sciences Gets FDA Approval For HIV-1 Regimen Complera - Quick Facts

(RTTNews) - Gilead Sciences, Inc. (GILD) Friday said it has received approval from the U.S. Food and Drug Administration, or FDA, for its single tablet HIV-1 regimen Complera, indicated for use in certain virologically-suppressed HIV patients.

Marketed as Eviplera, Complera was recently granted European regulatory approval for any HIV-infected adult patients without known mutations. In the U.S, Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens.

"The data supporting today's approval demonstrate Complera has the potential to help a broader range of HIV-infected patients who have achieved virologic control on another regimen," said Calvin J. Cohen, MD, M.Sc., Research Director, Community Research Initiative of New England and an investigator on clinical trials of Complera.

Complera contains Gilead's Truvada, which itself is a fixed-dose combination of two HIV medicines, and Janssen R&D Ireland's Edurant. Patients switching to Complera should have no history of virologic failure, have suppressed viral load for at least six months, be on their first or second antiretroviral regimen, and have no current or past history of resistance to Complera components. The

The approval is backed by clinical data from the Phase 3 SPIRIT clinical trial in which the efficacy of Complera was established in patients who were virologically suppressed HIV RNA on a stable ritonavir-boosted protease inhibitor-containing regimen.

The study found that, after 48 weeks of treatment with Complera, 89 percent of switch patients had viral load less than 50 copies/mL, compared to 90 percent of patients who remained on a PI-regimen for 24 weeks. Complera was well tolerated with very few treatment discontinuations due to adverse events.