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Thoughts on "Quad" Approval by FDA

By Paul E. Sax, M.D.

August 28, 2012

We now have a third single-pill treatment available for HIV treatment, co-formulated tenofovir/emtricitabine/elvitegravir/cobicistat. From the FDA announcement:

The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection. Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat ... Together, these drugs provide a complete treatment regimen for HIV infection.

A few quick thoughts about this approval, with the disclosure that I was an investigator on one of the phase III studies that led to its approval:

The bottom line is that Quad is an effective, very convenient option for initial HIV treatment. I suspect how much traction it gets from providers will depend on their experience in clinical practice related to safety and tolerability, and in the future to pharmacoeconomic factors, as generic antiretroviral strategies will become increasingly available that might challenge use of coformulated regimens.

(How about that name, "Stribild"? Pronounced with a long or short "I"? Wonder what the runner-ups were for that brand name.)

Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.

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