Elvitegravir/cobicistat/emtricitabine/tenofovir

Elvitegravir/cobicistat/emtricitabine/tenofovir gained approval by the U.S. Food and Drug Administration (FDA) on August 27, 2012, for use in adults starting antiretroviral treatment for the first time as part of the fixed dose combination.

Gilead's stated wholesale price of Stribild is US$28,500 per patient, per year. Gilead maintains that its pricing is comparable to other HIV medications on the market. Elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild) is priced at 39 percent higher than emtricitabine/rilpivirine/tenofovir (Complera), a three-drug HIV regimen approved a year earlier. At the time of Complera's approval, there were concerns about the US$20,500 wholesale cost of efavirenz/emtricitabine/tenofovir (Atripla), which is marketed by Gilead and Bristol-Myers Squibb. HIV drug prices have increased substantially. Atripla, a combination therapy released in 2006, was priced at US$13,800 per person, per year. Atripla's wholesale prices have risen to the level of Complera's at US$20,500. Rising drug costs and HIV cases, combined with tighter state budgets may burden the AIDS Drug Assistance Program (ADAP) to the breaking point. Kaiser Family Foundation reports that ADAP provided HIV drug benefit to 138,000 people in 2011, with a waiting list totaling 2,030 HIV-positive individuals. Many states including California, Colorado, Georgia, and Virginia are considering measures to cut ADAP spending.