First One-Pill-a-Day Drug for AIDS
Approval of 3-Drug Combo Will Simplify Treatment, Especially in Poor Countries
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
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
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. Miller said that once-a-day AIDS drugs would become available as
early as September in many poor countries receiving U.S. aid.