FDA approves first AIDS drug that requires just one pill a day

Fulfilling a long-held goal of AIDS researchers, federal regulators on Wednesday approved the first anti-HIV drug that requires patients to take only one pill a day.

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

The new drug could slow the virus from developing resistance to AIDS drugs by increasing patients' adherence to their drug regimens.

It could also lower their out-of-pocket expenses by reducing the number of co-payments for their insurance.

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

The development of Atripla represents 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 of Foster City, Calif.; and Sustiva, manufactured by New York-based Bristol-Myers Squibb.

Atripla

Cost: $1,150.88 wholesale for a 30-day supply, the same price as the drugs sold separately.

Availability: The makers said Atripla would be available to consumers within seven business days.

Their generic names are tenofovir, emtricitabine and efavirenz, respectively.

The companies said 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 drug's price in poor nations hit hard by AIDS will be set by Merck, which has international marketing rights to one form of the drugs.

Gilead spokesman James Loduca said the company will produce a salmon-colored pill for U.S. distribution and a white pill for sale abroad — suggesting they will be priced quite differently.

The drug will be manufactured in Canada.

The FDA said Atripla will be considered for use in 15 developing countries, many of them in Africa, under President Bush's 2004 initiative to combat AIDS. The five-year, $15 billion program aims to treat at least 2 million infected people.

The three drugs comprising Atripla are all reverse transcriptase inhibitors, which block a key enzyme that is unique to HIV.

Reverse transcriptase inhibitors were the first family of HIV drugs developed and are still the most widely prescribed for newly diagnosed patients.

The three drugs inhibit the replication of HIV within the body but are not a cure. Nor will the new pill be suitable for all patients: Sustiva, for instance, can cause birth defects.

Psychiatric symptoms including severe depression, suicide attempts, aggressive behavior, delusions and paranoia also have been reported in patients taking the drug.

Viread and Emtriva are already marketed in a once-daily combination pill called Truvada, so many patients are already taking only 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 the University of Southern California's Keck School of Medicine. "That's a key factor in AIDS, where you have to have an adherence of 95 percent plus" to prevent resistance from developing.

The efforts of the two companies to produce the pill are especially important to HIV-positive people who remember the early days of HIV drug cocktails when patients took 30 or more pills daily.

"People were talking about once-a-day as a magical, wonderful, far-off moment," said Craig Thompson, executive director of AIDS Project Los Angeles. "It was one of those things we were waiting for, and we've done a great job in getting there."

Material from The Washington Post and The Associated Press is included in this report.