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The United States allows Stribild, quadruple to single dose
(Blogmensgo, September 6th, 2012) The Food and Drug Administration (U.S. Food and Drug) is allowing from August 27, 2012 the placing on the market of Stribild, a quadruple-daily antiretroviral developed by Gilead Sciences. The new antiretroviral combines four molecules, two molecules already marketed (emtricitabine and tenofovir disoproxil fumarate, available since 2004 under the brand name Truvada) and two molecules which had not yet been approved by the health authorities (elvitegravir and cobicistat).
Results for Stribild (new name of the Quad) are equivalent or superior to those of two other combinations of daily antiretroviral drugs: the triple Atripla (efavirenz and Truvada combination) and quadruple (combining Truvada, Atazanavir and ritonavir). The combination therapy was administered to 1408 patients during forty-eight weeks resulting from a prior choice made at random: first cohort with Stribild or Atripla, second cohort with Stribild or other quadruple. After the test, the presence of HIV in the blood became undetectable in 88% of patients in the first cohort who took Stribild against 84% for Atripla and for 90% of the patients taking the Stribild second cohort against 87% for the quadruple with Truvada.
Gilead says Stribild side effects are usually limited to nausea and diarrhea. This quadruple may, however, in some cases, cause severe and even fatal disorders in the blood (lactic acid accumulation) and liver. Serious side effects are also possible: kidney disease, dyslipidemia, and immune reconstitution syndrome, among others. The Stribild is intended solely as during testing, in patients with HIV-1 who have never received antiretroviral therapy prior (see instructions pharmacological complete PDF).
The European Union, Canada and Australia have not yet authorised the market for Stribild, which has been requested by Gilead. This is the third single taken antiretroviral marketed by Gilead after Atripla (since 2006) and Complera (since 2011).
This article has been translated from our French blog, to view the original, click here.