FDA approves new combination pill for HIV treatment for some patients

FOSTER CITY, Calif. — The Food and Drug Administration has approved a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.

Gilead Sciences received regulatory for its treatment, Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate). Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir. The combination of emtricitabine and tenofovir disoproxil fumarate — approved in 2004 and marketed as Truvada — blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection.

"Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens," said Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "New combination HIV drugs like Stribild help simplify treatment regimens."

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