AEGiS-Chicago Tribune: FDA OKs 3-drug, once-a-day pill for HIV Chicago TribuneImportant note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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FDA OKs 3-drug, once-a-day pill for HIV

Chicago Tribune - July 13, 2006


WASHINGTON -- People infected with the virus that causes AIDS will soon be able to take a once-a-day pill that combines three drugs in a "cocktail" therapy that can be swallowed in a single dose.

The pill, called Atripla, includes three Food and Drug Administration-approved medicines that already form one of the most widely prescribed treatments for HIV and AIDS. The FDA approved the combination version Wednesday.

"Think how far we've come that we can treat HIV in one pill once a day," said Joel Gallant, a professor at Johns Hopkins University in Baltimore who runs a clinic for HIV patients. "Ten years ago people were taking horrendous and toxic regimens that saved their lives, but at a great cost."

But Atripla won't do away with the multiple other drugs that AIDS patients often must take to fend off infections and other complications of their weakened immune systems, said Frank Oldham Jr., executive director of the National Association of People with AIDS. And some patients will have to take other HIV drugs along with Atripla to combat the virus effectively.

Atripla combines Viread, Emtriva and Sustiva. Viread and Emtriva, both made by Gilead Sciences Inc. of Foster City, Calif., are now sold in combination under the brand name Truvada. Sustiva is made by New York-based Bristol-Myers Squibb Co.

The new pill will still be expensive: more than $1,100 for a month's supply. But switching to the combo pill would require insured patients to make just one co-payment, rather than two. Atripla is expected to be available within seven business days.

If the single pill does help patients stick to their pill-taking regimen, that in turn could slow the emergence, and ultimately the transmission, of drug-resistant strains of the virus.

Those strains can evolve when patients take less than 95 percent of their pills, said John Martin, head of Gilead Sciences.

"The fewer pills, the better they are able to achieve that 95 percent threshold," Martin said.

Several initial attempts by the two companies to combine the three drugs failed. The two companies then settled on a process called "bi-layer" technology to join them in a single pill.

"The fact that innovator companies in the U.S. have actually heeded the call to collaborate on this is just an amazing happening," said Veronica Miller, director of the Forum for Collaborative HIV Research.

Last month the FDA approved the first three-drug combination pill to treat HIV as part of foreign AIDS relief efforts.

Interest in Atripla could be greatest in developing countries, for both medical and logistical reasons, said Dr. Murray Lumpkin, deputy commissioner for international and special programs at the FDA.

"The idea of having a fixed-dose combination has been one of the, as you might say, one of the holy grails," Lumpkin said.


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