Gilead Gets Traditional OK on HIV Drugs

On Wednesday, Gilead Sciences Inc. announced it had been granted Food and Drug Administration (FDA) approval to include long-term trial data in the labeling for two of its HIV treatments.

The traditional approvals apply to Gilead's once-daily antiretroviral Viread and Truvada, which combines its antiretroviral Emtriva and Viread in a single daily dose. FDA granted accelerated approval to Viread and Truvada in October 2001 and August 2004, respectively.

Under the approvals, Gilead is allowed to include data from a 48-week clinical trail comparing once-daily regimen of Viread, Emtriva and Bristol-Myers Squibb's Sustiva to a regimen of GlaxoSmithKline's Combivir twice-daily and Sustiva once-daily. In that trial, 84 percent of the Viread group patients achieved a viral load of less than 400 copies of HIV genetic material per milliliter of blood compared with 73 percent of patients in the Combivir group. Eighty percent of the Viread group patients achieved and maintained a level of less than 50 HIV copies per milliliter compared to 70 percent of the patients in the Combivir group.

Gilead said it expects in the second quarter to file for FDA approval of a product that combines Truvada and Sustiva. Gilead and Bristol-Myers Squibb have established a joint venture to produce the drug. Truvada, Viread and Emtriva work by blocking reverse transcriptase, an enzyme that is necessary for viral replication.

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