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FDA approves new combo HIV pill

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The FDA has approved a new once-daily combination pill to treat HIV-1 infection in adults not previously treated for HIV, according to an FDA press release.

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

The new combination pill (Stribild, Gilead) contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate and provides a complete treatment regimen for HIV.

According to the FDA press release, the safety and efficacy of the pill was assessed in 1,408 adult patients not previously treated for HIV in two double-blind trials. Researchers randomly assigned patients to receive the combo pill or once-daily emtricitabine/tenofovir/efavirenz for the first study; and to the combo pill or emtricitabine/tenofovir/efavirenz plus atazanavir and ritonavir once-daily for the second study.

Data indicated that between 88% and 90% of patients assigned the new combo pill had an undetectable amount of HIV in their blood vs. 84% assigned emtricitabine/tenofovir/efavirenz and 87% assigned emtricitabine/tenofovir/efavirenz plus atazanavir and ritonavir.