FDA Approves Once-a-Day Pill for HIV
New York Times (08.28.12):: Andrew Pollack
Gilead Science’s once-a-day HIV treatment that combines four HIV drugs into one tablet has been approved by the Food and Drug Administration. Gilead says Stribild, previously known as Quad, will cost about $28,500 a year.

Stribild is the third once-a-day HIV treatment Gilead has brought to market, after Atripla in 2006 and Complera in 2011. Stribild does not represent a significant leap medically compared to the others. In clinical trials that led to its approval, Stribild was shown to be roughly equivalent to Atripla and to another combination, though without some of Atripla’s psychiatric side effects. Approximately 88 percent-90 percent of patients who took Stribild had undetectable HIV in their blood after 48 weeks, compared to 84 percent taking Atripla and 87 percent taking a combination of Gilead’s Truvada, Bristol-Myers Squibb (BMS)’s Reyataz, and Abbott’s Norvir.

Stribild is composed of emtricitabine and tenofovir, which are also found in Atripla and Complera, as well as elvitegravir and cobicistat - neither of which has been approved for use independently. What could differentiate Stribild commercially is that Gilead owns all the ingredients, whereas Atripla includes a BMS drug and Complera contains a drug from Johnson & Johnson - meaning Gilead must split profits from those drugs.

Michael Weinstein, president of the AIDS Healthcare Foundation, which treats more than 100,000 HIV/AIDS patients worldwide, called Gilead’s pricing of Stribild “shockingly irresponsible.” “It’s just unsustainable at these levels,” he said.

Gilead spokesperson Erin Rau said price “reflects a reasonable return on our product development investment.” The company plans to provide discounts to state AIDS Drug Assistance Programs, and offer programs to help privately insured patients with Stribild’s cost, she said. Further, Gilead has granted certain Indian generic drug manufacturers rights to produce Stribild for distribution in poor countries.
25 October 2012
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