RENEE MONTAGNE, host:
The Food and Drug Administration has approved a new once-daily pill for people with HIV. It combines three medications in one, and represents the collaboration of three major AIDS drug manufacturers.
The pill is expected to make it easier for people in the United States to keep up with treatments, but also make treatments more available for people in developing countries.
NPR's Brenda Wilson reports.
Mr. ANDREW VON ESCHENBACH (Acting Commissioner, Food and Drug Administration): The FDA is pleased to announce the approval of the very first once-a-day combination pill that can and will fundamentally change the treatment paradigm for people living with HIV/AIDS.
BRENDA WILSON reporting:
Dr. Andrew von Eschenbach is the acting commissioner of FDA.
Dr. ESCHENBACH: A decade ago, HIV/AIDS patients on combination therapy would take perhaps as many as 12 to 15 pills a day, and often throughout the day and even during the middle of the night. Now, as initial therapy, one pill once a day, containing three important components of their treatment.
WILSON: The drug is called Atripla. It's primarily for use by people who have not been on treatment. It may be possible for some patients already in therapy to switch to one-a-day pills if there's been no resistance or failure, or the pills may be combined with other medications.
For millions of people in developing countries, the single pill has an even greater advantage. It'll be easier to take, to store, and to get to people on a daily basis and maintain quality in settings where there's no electricity.
Dr. Murray Lumpkin(ph), who is the director of the FDA's International Programs, says it will become part of the administration's AIDS relief package.
Dr. MURRAY LUMPKIN (Deputy Commissioner for International and Special Programs, Food and Drug Administration): It's one thing to have medicine available, but it will only be effective when people can indeed take it as they are supposed to. They can take it over the timeframe that they are supposed to not only for this to be an effective, safe medicine for them, but also for the larger community in trying to mitigate the rise of resistant viruses from situations where people are under treated or poorly treated.
WILSON: The new drug is the result of a deal with Bristol-Myers Squibb, Gilead, and Merck, brokered by the FDA to share compounds in order to simplify treatments. Lumpkin says the pill is one of 25 other products that the FDA has fast tracked for use in developing countries.
Most three-in-one AIDS pills until now have been provided by generic companies who simply copied and combined the compounds of brand-name companies. But Jill DeSimone, a senior vice president at Bristol-Myers Squibb says competition from generics is not the reason the companies agreed to collaborate.
Ms. JILL DESIMONE (Senior Vice President, Bristol-Myers Squibb): Actually, we started our discussions in 2003. We signed the deal in 2004, and it really was about patients. Bristol-Myers Squibb actually had early access programs as early as 1989. It really wasn't the drivers of other companies; it really was about the patients.
WILSON: Even though it is just one pill a day, the price won't change. Here in the U.S. that's about $1,200 a month, or the total price of the individual ingredients. For developing countries, the companies are negotiating and the price has not been determined.
AIDS doctors who work in the U.S. and abroad welcomed FDA's announcement, remembering a time not too long ago when a cumbersome regimen of AIDS pills seemed like a miracle.
Brenda Wilson, NPR News, Washington. Transcript provided by NPR, Copyright NPR.
