Atripla,
a new fixed-dose once-a-day tablet for the treatment of HIV-1, is shown at
the National Press Club in Washington, Wednesday, July 12, 2006. [AP
Photo] |
People infected with the virus that causes AIDS will soon be able to take a
once-a-day pill that combines three drugs in a "cocktail" therapy that can be
swallowed in a single dose.
The pill, called Atripla, includes three Food and Drug
Administration-approved medicines that already form one of the most widely
prescribed treatments for HIV and AIDS. The FDA approved the combination version
Wednesday.
The medicine will still be expensive: more than US$1,100 for a month's
supply.
Atripla can replace the two or more pills HIV-positive patients now must take
each day to keep the human immunodeficiency virus in check, making it simpler to
stick to a treatment regimen. The new pill is expected to be available within
seven business days.
"As a physician, I know, whether in dealing with cancer or dealing with
infection, that's an opportunity to significantly improve compliance. And
compliance with therapy is as important as the therapy itself for a successful
outcome," said Dr. Andrew von Eschenbach, the FDA's acting commissioner.
If the single pill does help patients stick to their pill-taking regimen,
that in turn could slow the emergence, and ultimately, transmission, of
drug-resistant strains of the virus. Those strains can evolve when patients take
less than 95 percent of their pills, said John Martin, head of Gilead Sciences
Inc., the manufacturer of two of the drugs in Atripla.
"The fewer pills, the better they are able to achieve that 95 percent
threshold," Martin said.
Atripla won't do away with the multiple other drugs that AIDS patients often
must take to fend off infections and other complications of their weakened
immune systems, said Frank Oldham Jr., executive director of the National
Association of People with AIDS. And some patients will have to take other HIV
drugs along with Atripla to combat the virus effectively.
Atripla combines Viread (tenofovir), Emtriva (emtricitabine) and Sustiva
(efavirenz). Viread and Emtriva, both made by Gilead of Foster City, Calif., are
now sold in combination under the brand name Truvada. Sustiva is made by New
York-based Bristol-Myers Squibb Co.
The pill will be just as expensive as Truvada and Sustiva when purchased
separately: The wholesale price will be US$1,150 for a 30-day supply. Switching
to the combo pill would require insured patients to make just one, rather than
two, co-payments, saving some money.
Several initial attempts by the two companies to combine the three drugs
failed. The two companies then settled on a process called "bi-layer" technology
to join them in a single pill.
"The fact that innovator companies in the US have actually heeded the call to
collaborate on this is just an amazing happening," said Veronica Miller,
director of the Forum for Collaborative HIV Research. The effort, Miller said,
could lead to future collaborations on better drug combinations formulated for
use in infants and children.
The FDA approved last month the first three-drug combination pill to treat
HIV as part of foreign AIDS relief efforts. Atripla also will be available for
use in the 15 countries covered by that program, the President's Emergency Plan
for AIDS Relief. Unlike Atripla, the other combo pill must be taken twice daily
and is for sale only outside the United States.
Interest in Atripla as the first once-daily, three-drug pill may be greatest
in developing countries, for both medical and logistical reasons, said Dr.
Murray Lumpkin, deputy commissioner for international and special programs at
the FDA.
"The idea of having a fixed-dose combination has been one of the, as you
might say, one of the holy grails," Lumpkin said.
About 40 million people worldwide, including 1 million Americans, are HIV
positive. Each year, roughly 5 million people are infected with HIV and 3
million die from AIDS, according to the World Health Organization.
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. Serious psychiatric symptoms including severe
depression, suicide attempts, aggressive behavior, delusions and paranoia also
have been reported in patients taking the drug.
Gilead, Bristol-Myers Squibb and Merck & Co. Inc. intend to seek approval
to sell the pill outside the US
Merck, based in Whitehouse Station, N.J., is involved because it has rights
to market one of the three drug ingredients, efavirenz, under the brand name
Stocrin in many foreign countries, including most of the developing
world.
