First One-Pill-a-Day Drug for AIDS

Approval of 3-Drug Combo Will Simplify Treatment, Especially in Poor Countries

By Todd Zwillich
WebMD Health News

Reviewed By Louise Chang, MD
on Wednesday, July 12, 2006

July 12, 2006 -- FDA officials Wednesday announced approval of a new three-drug combination pill that could mean a single pill a day for many HIV/AIDS patients.

Regulators heralded the drug as the first chance for patients to take their medication in such a simple form. HIV/AIDS patients now must take several pills daily, often in complicated combinations.

Officials said the single pill -- known as Atripla -- would be a great help for aid programs in poor countries hit hardest by the AIDS epidemic.

Andrew von Eschenbach, MD, acting commissioner of the FDA, called the drug's introduction a "landmark" in the treatment of HIV/AIDS. The new drug "can and will fundamentally change the treatment paradigm for people living with HIV and AIDS," he told reporters Wednesday.

Atripla does not actually contain any new drugs. Instead, it combines an antiviral drug called Sustiva with a two-drug pill called Truvada (a combination of Viread and Emtriva). All three drugs fight HIV in the body.

Simplicity a 'Holy Grail'

Public health experts have long viewed complex AIDS drug regimens as a barrier to effective treatment. Incomplete drug dosing can give rise to drug-resistant strains of the virus.

"This idea of having a fixed-dose combination has been one of the, if you will, holy grails of trying to come up with therapies," said Murray M. Lumpkin, MD, FDA's deputy commissioner for International and Special Programs.

Atripla was approved in only three months under a fast-track clearance process reserved for AIDS and other epidemic drugs. Officials praised the collaboration between three drug makers to formulate and market the product -- Bristol-Myers Squibb, Gilead Sciences, and Merck & Co.

Nearly 40 million people are currently living with HIV and AIDS, the majority of them in poor nations in Africa and Asia. Nearly 3 million died of the disease last year, according to the United Nations organization known as UNAIDS.

No Price Break

The U.S. has mounted a five-year, $15 billion effort to provide anti-AIDS drugs and prevention strategies to poor nations.

The combination of three drugs in Atripla won't mean a discount for patients, insurance companies, or governments.

Eric Miller, a spokesman for Sustiva maker Bristol-Myers Squibb, said the product would sell at a wholesale price of $1,150.88 for a 30-day supply.

"The price of Atripla is the price of its individual components combined," he said.

Company officials said they expect the drug to hit U.S. markets within the next week. Countries that have already approved the use of the drug's three components could begin taking delivery as early as September, Miller said.

SOURCES: Andrew von Eschenbach, MD, acting commissioner, FDA. Murray Lumpkin, MD, deputy commissioner for international and special projects, FDA. UNAIDS, "HIV Epidemiology," 2005. Eric Miller, spokesman, Bristol-Myers Squibb.

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