The FDA has approved Stribild, a complete once-daily single tablet regimen, for the treatment of HIV-1 infection in treatment-naïve adults, according to Gilead Sciences, the Foster City, Calif.-based biopharmaceutical company that developed the drug.
Stribild, referred to as “Quad” prior to FDA approval, combines four compounds in one daily tablet: elvitegravir 150mg, an integrase inhibitor; cobicistat 150mg, a pharmacoenhancing agent; emtricitabine 200mg and tenofovir disoproxil fumarate 300mg.
“Over the past decade, co-formulated HIV medicines have simplified therapy for many patients and have become standard of care,” said Paul Sax, principal investigator of one of the Stribild pivotal studies. “Today’s approval of Stribild will provide physicians and their patients an effective new single tablet treatment option for individuals starting HIV therapy for the first time.”
The approval of Stribild is supported by 48-week data from two pivotal phase III studies in which the single tablet regimen met its primary objective of non-inferiority compared to Atripla (efavirenz 600mg, emtricitabine 200mg, tenofovir disoproxil fumarate 300mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada (emtricitabine, tenofovir disoproxil fumarate) (Study 103).
“For much of the company’s 25-year history, Gilead has focused on the development of improved treatments and simplified regimens for HIV,” said John C. Martin, chairman and CEO of Gilead Sciences. “Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success, and we are proud to introduce a new single tablet regimen for the healthcare and patient communities.”
Stribild is the third single tablet HIV regimen developed by Gilead. The first, Atripla, was approved in 2006 and is marketed by Gilead and Bristol-Myers Squibb in the U.S. The second single tablet regimen, Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate), which combines Gilead’s Truvada and Janssen R&D Ireland’s rilpivirine, was approved in 2011.
Applications for marketing approval of Stribild are also pending in Australia, Canada and the E.U. In the developing world, Gilead has granted multiple Indian manufacturing partners and the Medicines Patent Pool the right to develop generic versions of Stribild and distribute them to 100 developing countries. These agreements include a complete technology transfer of the manufacturing process for the single tablet regimen.