Results of Study 102 for Quad (Gilead) for HIV

Phase III results were announced from the pivotal Study 102 demonstrating that Quad,from Gilead Sciences, a fixed-dose, single-tablet regimen made up of the investigational drugs elvitegravir and cobicistat combined with the two active ingredients in Truvada (emtricitabine and tenofovir), is non-inferior to Atripla (efavirenz/tenofovir/emtricitabine) after 48 weeks of therapy in treatment-naive adults. At the end of the trial, 88% of patients who took Quad had achieved HIV RNA levels (viral load) of less than 50 copies/ml, ie no detectable levels of HIV in their blood, compared with 84% for those on the three-drug combination pill. Gilead submitted a New Drug Application to the FDA for Quad in October last year and has been given a Prescription Drug User Fee Act action date of August 27 2012. The combo was filed in Europe in November 2011.