Gilead's Complera approved for HIV patients already on stable drug regimens

FDA approves drug for use in patients switching from other therapies

FOSTER CITY, Calif. — The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.

"Complera is an effective single-pill therapy with a demonstrated safety profile and has rapidly become an important option for appropriate HIV patients who are initiating antiretroviral treatment," Community Research Initiative of New England research director and Complera clinical trial investigator Calvin Cohen said in a statement on behalf of Gilead.


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