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Gilead Sciences, Inc. ( GILD - Analyst Report) recently announced encouraging detailed 24-week data from a phase II study (study 102) on its HIV single tablet regimen (STR). The STR includes tenofovir alafenamide (TAF), a pro drug of Gilead’s HIV drug Viread. The study compared a once-daily STR of TAF 10 mg, elvitegravir 150 mg, cobicistat 150 mg, Emtriva 200 mg with Stribild.
We remind investors that Gilead gained approval from the US Food and Drug Administration (FDA) for Stribild in Aug 2012 as a first-line therapy for treating adults with HIV-1 infection. Stribild is a combination of elvitegravir, cobicistat and Truvada. We note that Truvada itself is a combination of Viread and Emtriva. Data from the above study revealed that the TAF-based regimen worked as effectively as Stribild for treating treatment-naïve HIV infected adults. We note that Gilead had announced top-line data from the study in Oct 2012.
Gilead also stated in its press release that it had commenced 2 phase III studies of two (studies 104 and 111) to evaluate the TAF-based regimen versus Stribild for treating HIV patients, who are new to therapy.
We are impressed with the encouraging data on the HIV candidate. Successful development and commercialization of the TAF-based regimen would further strengthen its HIV portfolio.
We remain optimistic on the growth prospects of Gilead's HIV drugs such as Truvada and Atripla. We are also encouraged by the sales ramp of the newly launched Complera/Eviplera. The strong performance of Stribild since launch is also encouraging.
Gilead, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma stocks such as Array Biopharma ( ARRY - Snapshot Report) , Celldex Therapeutics, Inc. ( CLDX - Analyst Report) and Kythera Biopharmaceuticals, Inc. are comparatively well placed and carry a Zacks Rank #2 (Buy).