2 New Combo AIDS Pills Get FDA Nod

Epzicom and Truvada Each Combine 2 Existing AIDS Drugs

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Aug. 3, 2004 -- The FDA has approved two new two-in-one AIDS drugs. For people taking the lifesaving medicines, that means fewer pills and less complicated drug schedules.

Easier to take means fewer missed doses. And missed doses, for whatever reason, are a big problem. Give the virus even a small chance for a comeback, and drug-resistant HIV strains begin to develop. Even when taken every day, exactly on time, in exactly the right doses, drug-resistant HIV eventually arises is most patients. That's why new AIDS drugs with different modes of action are always needed.

Both of the new combination pills -- Epzicom and Truvada -- combine existing AIDS drugs.

Epzicom is a combination of Ziagen and Epivir. The two-drug combination is used together with other anti-HIV drugs. Like Ziagen and Epivir, Epzicom is made by GlaxoSmithKline. To give patients' insurance companies time to catch up with the change, GlaxoSmithKline is offering patients a voucher program that will give them a free 60 day supply of the drug.

The other new pill, Truvada, is a combination of Viread and Emtriva. Truvada is also intended for use in combination with other anti-HIV drugs. The drugs are made by Gilead Sciences.

Gilead has announced that it will sell Truvada at cost in Africa and in 15 non-African nations designated by the United Nations as "least-developed" countries. The inventors of Truvada's component parts have agreed to waive their royalties for sale of the drug in these nations, which carry 70% of the worlds' AIDS burden. The at-cost version of Truvada will be light blue in color to keep it from being sold in developed nations, where the pills will be dark blue.

Neither Epzicom nor Truvada cures AIDS or prevents the spread of the AIDS virus.

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SOURCES: News release, FDA. News release, GlaxoSmithKline. News release, Gilead Sciences.
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