By Marc
Kaufman
Washington Post Staff Writer
Thursday, July 13, 2006; A01
The
world's first single-pill, once-a-day AIDS treatment was approved
yesterday by the Food and Drug Administration -- a medication that
experts say will make it easier for infected people to keep the virus
under control.
Developed
in an unusual cooperative venture by the makers of two rival drugs, the
new combination pill, called Atripla, marks a milestone in the treatment
of AIDS. While patients used to take 10 or more pills a day, they will
now be able to control their disease with one medication.
"This is a
landmark for those suffering with HIV and AIDS," said acting FDA
Commissioner Andrew von Eschenbach. People will be more likely to take a
single pill consistently than several of them, he said, and "compliance
with therapy is as important as the therapy itself for a successful
outcome."
Deputy FDA
Commissioner Murray Lumpkin, who runs the agency's international and
special programs, called approval of Atripla a major achievement. "A
single, fixed-dose pill has long been seen as the holy grail of AIDS
treatment," he said.
The
combination pill will not only keep patients healthier, officials said,
but also help slow the development of community-wide resistance to AIDS
drugs. If patients do not take the drugs regularly, the human
immunodeficiency virus has a better chance of mutating into new forms of
AIDS that are not affected by the available medications, first in
individual patients and later in others.
At a news
conference yesterday, unusual in announcing a new drug approval, the
agency officials said the combination pill will first be available in
the United States, but the need is greatest in poor nations where AIDS
treatment is often unavailable or inadequate. The sometimes confusing
directions involved with taking many pills a day -- some on a full
stomach and some on an empty one -- has kept effectiveness rates low.
"We know
that an HIV-AIDS patient needs to take 95 percent of his or her pills or
they won't work," said John C. Martin, chief executive of Gilead
Sciences Inc., one of the companies in the Atripla project. "So the
fewer pills a patient needs to take, the better the outcome."
Martin
said creating the combination pill was difficult, with five failed
formulations before the successful one was created. "This is not simply
a matter of putting together the three drugs," he said. "They have to be
put together in a way that each reacts as it does when it's alone, and
that can get complicated."
The new
drug will combine the two most prescribed AIDS medications --
Bristol-Myers Squibb Co.'s Sustiva and Gilead's Truvada, which is itself
a two-drug combination. Gilead officials said Atripla will cost about
$1,100 a month, which is equal to the current cost of taking Sustiva and
Truvada. The drug's price in poor nations hit hard by AIDS will be set
by Merck and Co., which markets Sustiva under the name Stocrin in
developing countries.
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.
Von
Eschenbach said the FDA wants to encourage other companies to join
forces in developing new drugs. The computer industry learned long ago
to cooperate in creating new products, he said, and drugmakers are just
beginning to move to that model.
The
pharmaceutical industry has been under substantial pressure to simplify
AIDS-treatment regimens in particular, and companies have been combining
medicines for several years. But until the joint venture that created
Atripla was formed, a once-a-day pill proved elusive -- for reasons more
commercial than scientific.
The FDA
said Atripla will be considered for use in 15 developing countries, many
of them in Africa, under President Bush's 2003 initiative to combat
AIDS. The five-year, $15 billion program aims to treat at least 2
million infected people.
Many of
the AIDS drugs used in the program have patent protection but are made
in generic versions by companies abroad -- for sale exclusively in poor
nations -- with the approval of the patent-holding company. Several
Indian companies in particular are active now in making AIDS drugs,
including three-drug combinations, but none has yet produced a
once-a-day pill.
There are
as many as 40 million people worldwide with HIV or AIDS, and more than a
million in the United States. About 40,000 new U.S. cases are reported
annually.
The FDA
has approved 28 products in the United States to treat HIV infection --
most of them as high-priority applications. The Atripla application was
approved after a review of only three months, but FDA officials said the
agency worked with the manufacturers for several years before the
application was submitted.
FDA
approved Sustiva in 1998 and the two Gilead drugs -- Viread and Emtriva
-- in 2001 and 2003. Their safety and effectiveness in combination were
established in a 48-week clinical study with 244 infected adults. In
that trial, 80 percent of the people experienced a significant reduction
in their virus levels and a substantial increase in the number of
healthy cells that fight against infection.
Combination drugs -- or drug "cocktails" -- are especially useful in
treating HIV and AIDS because, used regularly, they can keep the
fast-evolving virus from mutating into new, hard-to-treat variations.
While Atripla will reduce the number of anti-retroviral pills a patient
needs to take, officials said, additional medications to boost the
immune system and protect against other infections will often be needed.
