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8/2/2004

FDA Approves Two Combination HIV Products

Kate Traynor

The Food and Drug Administration (FDA) announced today that it approved the marketing of two fixed-dose combination therapies for the treatment of HIV infection.

Each combination product contains two previously approved reverse-transcriptase inhibitors. Both products are indicated for the treatment of HIV infection as part of a drug regimen that includes other classes of antiretrovirals, such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors.

Truvada, by Gilead Sciences Inc., contains 200 mg of emtricitabine—a nucleoside analogue—and 300 mg of the nucleotide analogue tenofovir disoproxil fumarate per oral tablet. According to the FDA-approved labeling (PDF) for Truvada, the recommended dosage is one tablet per day taken with or without food.

Gilead's product will be provided as dark blue, capsule-shaped, film-coated tablets packaged 30 per bottle.

FDA also approved GlaxoSmithKline's Epzicom, which contains 600 mg of abacavir sulfate and 300 mg of lamuvidine, both of which are nucleoside analogues.

According to the product's FDA-approved labeling (PDF), Epzicom is formulated for once-daily administration with or without food or water. The product will be sold in 30-each bottles of orange, film-coated tablets that are described in the labeling as "modified-capsule shaped."

A company spokeswoman said she expects the product to be available in pharmacies by the end of this month. According to GlaxoSmithKline, some patients will be able to receive a free 60-day supply of Epzicom through a voucher program.

In its announcement, FDA stressed the importance of combination drug formulations for simplifying the drug regimen of patients taking antiretroviral therapy. The agency also noted that fixed-dose combination products are needed to combat HIV infection in developing countries.