Once-a-day HIV drug cocktail in one pill wins FDA approval
Updated
7/16/2006 7:02 AM ET
By Steve Sternberg, USA TODAY
WASHINGTON
The federal government on Wednesday approved the first HIV treatment that packs a triple-drug cocktail into a one-a-day pill.Doctors say the salmon-colored pill will vastly simplify AIDS care and turn what a few years ago was a bothersome regimen of 20 or 30 tablets to one pill taken before bed.
To be sold as Atripla, the pill includes doses of three drugs now sold in the USA by two companies. The drugs are Bristol-Myers Squib's Sustiva and Gilead Pharmaceutical's Truvada, a combo of Viread and Emtriva.
Taking the trio as a single pill makes it less likely that patients will miss doses, which would allow the virus to rebound and become resistant to treatment, doctors say. Keeping the virus in check also helps lower the risk that a patient will infect someone else.
"To me, it achieves the ultimate goal," says AIDS specialist John Bartlett of Johns Hopkins University. "It's a pill you can take without regard to meals, it's about as potent a regimen as we have, and it's relatively free of side effects."
The Food and Drug Administration approved the drug in three months, as part of a fast-track process introduced two years ago, after research showed the pill is equivalent to the drugs taken separately. The wholesale price of a 30-day supply of the pill will be $1,150.88, the same as Truvada and Sustiva purchased separately, Gilead officials say. Atripla is expected to be on sale within four days.
"It's a big step forward from where we were 10 years ago," says Norbert Bischofberger, Gilead's vice president of research and development. "Even though (anti-HIV drugs) had a miraculous effect, they were impossible for anybody to take long-term."
FDA's acting commissioner, Andrew von Eschenbach, told reporters Wednesday that "compliance with therapy is as important as therapy itself."
Robert Spellman, 58, of New York, was diagnosed with HIV in 1990 and began taking AIDS drug cocktails soon after they became available in 1996. "In all, I think I took maybe 35 pills a day. It was horrible," he says. "It made you nauseated. It was embarrassing. If you were out somewhere, you didn't want to take a ton of pills."
Bischofberger says that 60% of HIV patients in the USA take the three drugs, but not in one pill.
The approval also means that the drug can be made available in the developing world through the President's Emergency Plan for AIDS Relief. Gilead is negotiating those prices with Merck, which owns the marketing rights to Sustiva outside the USA and the major countries of Europe, Bischofberger says. Both companies offer steep discounts in poor nations.
Even if the drug costs less than a dollar a dose, the price of many generics, it may be too high for many countries to afford, says Kevin DeCock, director of World Health Organization AIDS programs. "We have to accept there's no way that treatment can be paid for by these countries on their own."