The concept of a single-tablet regimen for HIV represents the simplification of antiretroviral therapy. At the altar, awaiting the regulatory decision is Gilead Sciences Inc.'s (GILD: Quote) Quad, the third single-tablet HIV regimen. Atripla, approved in 2006, and Complera, approved in 2011, are the other two single-tablet HIV regimens.
Quad contains Gilead's two investigational drugs - Elvitegravir, which is an integrase inhibitor, and Cobicistat, a boosting agent, in combination with Truvada (Emtricitabine and Tenofovir disoproxil fumarate). If approved, Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor. Unlike other classes of antiretroviral drugs, integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells.
Gilead's Atripla contains three HIV medicines in one pill - Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate). Complera contains Emtriva, Edurant (rilpivirine) and Viread combined in one pill. Truvada, Gilead's second-largest sales-getter, combines Emtriva and Viread in one tablet.
In pivotal phase III studies, Quad demonstrated comparable efficacy with Atripla and ritonavir-boosted atazanavir plus Truvada in achieving viral suppression and increasing CD4 cell counts after 24 and 48 weeks.
In May of this year, an FDA panel voted 13 to 1 in support of approval of Quad for the treatment of HIV-1 infection in adults. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so. The FDA's decision date is set for August 27, 2012.
Gilead submitted the NDA for Quad's components - Elvitegravir and Cobicistat in June of this year. The company has made regulatory filings for Quad, Elvitegravir and Cobicistat in Europe also.
HIV drugs namely, Atripla, Truvada, Viread, Complera and Emtriva account for a major chunk - making up 85%-86% of the company's total revenue. In the second quarter of 2012, Gilead's HIV franchise sales were up 15% to $1.986 billion. Quad, if approved, will be the next to join Gilead's HIV product portfolio.
Shares of Gilead have thus far hit a low of $34.45 and a high of $58.84. The stock closed Friday's trading at $56.75, up 0.11%.
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by RTT Staff Writer
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