Gilead Sciences files for approval of combination anti-HIV pill

Gilead Sciences on Monday applied for marketing approval in the United States and the European Union for a combination pill containing its nucleotide reverse transcriptase inhibitor Viread and its nucleoside reverse transcriptase inhibitor Emtriva. The combination pill will be taken once daily and can be combined with other anti-HIV medications. "There is a need to simplify HIV drug regimens in order to improve patient quality of life and adherence to therapy," said John C. Martin, president and chief executive officer at Gilead. "Recent advances in the development of efficacious, well-tolerated, and conveniently dosed medications are helping make HIV regimens easier to manage. We believe that the coformulation of once-daily Viread and Emtriva may help further reduce the treatment burden on patients and improve adherence."

Each tablet will contain 300 milligrams of Viread and 200 milligrams of Emtriva. Viread was cleared by the Food and Drug Administration for individual use in 2001; Emtriva was approved in 2002. Both medications work by blocking reverse transcriptase, an enzyme by which HIV duplicates itself. Company officials hope the combination pill will be available in the United States in early 2005.

GlaxoSmithKline and Abbott Laboratories currently have the only approved combination anti-HIV pills available. Glaxo offers Combivir, a combination of AZT and 3TC, and Trizivir, which combines AZT, 3TC, and Ziagen; Abbott offers Kaletra, which includes the protease inhibitor lopinavir with a small, boosted dose of the protease inhibitor Norvir.

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