A once-daily pill that combines three drugs used to treat HIV received
federal approval Wednesday, giving U.S. patients the first triple
"cocktail" therapy that can be swallowed as a single dose.
The pill, called Atripla, combines three Food and Drug
Administration-approved AIDS drugs that already form one of the most
widely prescribed AIDS "cocktails."
Atripla can replace the two or more pills HIV-positive patients now
must take each day to keep the human immunodeficiency virus in check,
as well as eliminate the need for multiple co-payments when the drugs
are purchased separately.
That should simplify the treatment of HIV and AIDS and in turn could
slow the emergence - and ultimately, transmission - of drug-resistant
strains of the virus. Those strains can evolve when patients skip
pills.
"It is a major, major breakthrough for all people living with HIV and
AIDS," said Frank Oldham Jr., executive director of the National
Association of People with AIDS. Oldham cautioned that AIDS patients
often still must take multiple other drugs to fend off infections and
other complications of their weakened immune systems. Some patients
also will take Atripla with a fourth drug to combat HIV.
Atripla combines Viread (tenofovir), Emtriva (emtricitabine) and
Sustiva (efavirenz). Viread and Emtriva, both made by Gilead Sciences
Inc. 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 wholesale price of the new pill will be $1,150 for a 30-day
supply, or the same as for Truvada and Sustiva when purchased
separately. The new pill is expected to be available within seven
business days.
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 U.S. 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. That combo pill, for
sale only outside the United States, must be taken twice daily.
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
behaviour, delusions and paranoia also have been reported in patients
taking the drug.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
# posted by Network @ 10:29 PM
