Once-a-Day HIV Pill Approved

The drug, called Atripla, combines the three most widely prescribed HIV drugs into one pill, providing patients with a simpler medication regimen.

Atripla could slow HIV drug resistance by helping patients avoid missing doses. It could also lower their out-of-pocket expenses by reducing the number of co-pays under their insurance.

The approval is "a landmark in the treatment of HIV/AIDS," said Andrew C. von Eschenbach, acting commissioner of the Food and Drug Administration, in announcing the approval.

The development of Atripla is the first time that two pharmaceutical manufacturers have combined their HIV drugs into one pill.

The salmon-colored pill, about the size of a multivitamin, contains Viread and Emtriva, produced by Gilead Sciences Inc. of Foster City, Calif., and Sustiva, manufactured by Bristol-Myers Squibb Co. of New York.

"The concept that two rival drug companies were able to overcome marketing, legal and manufacturing challenges is a really good sign for potential future activities," said Craig E. Thompson, executive director of AIDS Project Los Angeles. "This is a new level of cooperation."

The companies said that Atripla would be available to consumers within seven business days and that its wholesale price would be $1,150.88 for a 30-day supply, the same price as the drugs sold separately.

The three drugs, whose generic names are tenofovir, emtricitabine and efavirenz, are reverse transcriptase inhibitors, which block an enzyme necessary for HIV replication. Reverse transcriptase inhibitors were the first family of HIV drugs developed and are still the most widely prescribed family of drugs for newly diagnosed patients.

When a patient develops resistance to one or more of the drugs, physicians typically add a second family of drugs called protease inhibitors. Experts said companies were looking for ways to incorporate them into the pill.

Sustiva and Emtriva are available in a once-daily pill called Truvada, so many patients take two pills a day.

But studies of various types of drugs have shown that "the fewer pills you can get, the better the compliance," said Dr. Joseph Cadden of USC's Keck School of Medicine. "That's a key factor in AIDS, where you have to have an adherence of 95% plus" to prevent drug resistance.