US OKs first once-daily AIDS combination pill

Atripla, which contains Bristol-Myers Squibb Co.'s drug Sustiva and Gilead Inc.'s medicines Viread and Emtriva, is latest step in making it easier for AIDS patients to keep the human immunodeficiency virus or HIV in check -- a process that once included dozens of daily pills. "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," U.S. Food and Drug Administration Deputy Commissioner Murray Lumpkin told reporters. Experts hope the convenience of a single, once-daily pill will help patients continue treatment and take their medicines on schedule, both keys to keeping HIV from developing resistance to drugs. In the early days of AIDS treatment, patients had to take dozens of pills at different times each day, some with or without food. Experts soon realized that was too difficult. The three-drug combination found in Atripla is the most commonly prescribed regimen for U.S. patients starting HIV treatment, said Norbert Bischofberger, Gilead's executive vice president of research and development, in an interview. The new pill "is a really nice advance. You can't make it any simpler," Bischofberger told Reuters, adding other possible combination pills are in the works. Atripla will cost $1,150.88 for a 30-day supply and will be available within seven business days, the drugmakers said. Gilead's Viread and Emtriva are already available as a combination pill called Truvada, which launched last year and is on track to reach $1 billion in 2006 sales. Gilead shares were off 6 cents to $61.70 on Nasdaq in late afternoon trade amid a general retreat in U.S. stocks. Shares of Bristol were off 40 cents, or 1.6 percent, at $25.08 on the New York Stock Exchange. The approval had been widely anticipated. None of the current AIDS-fighting medicines cure the disease, but they can suppress the virus for years. The three drugs in the new pill work by blocking reverse transcriptase, an enzyme HIV needs to replicate. Wednesday's approval also makes the drug available for a U.S. program to fight AIDS in 15 other countries. Close to 40 million people worldwide have the virus, which causes acquired immune deficiency syndrome or AIDS. About 1 million Americans have been diagnosed as having the virus, according to United Nations' estimates. Merck & Co Inc markets Bristol's Sustiva in most developing countries under the brand Stocrin. Bristol holds marketing rights for the United States, Canada and some European nations. The price for the drug in countries hit hardest by the disease has not been set, Merck said in a statement, but it likely will be at a level where the company would not profit. As with all AIDS medicines, patients may develop resistance and need to switch to another combination. Atripla's side effects may include abnormal dreams, hallucinations and kidney problems. Women who take it should not become pregnant because it may cause birth defects. In June, the FDA approved another three-in-one AIDS pill for use in poor countries under a global relief plan. That product contains generic versions of older HIV drugs, and the combination is not sold in the United States. "Source":[ http://www.topix.net/content/reuters/3929317093055548172438514815211563833037?threadid=4PTHT64M8V9D8P61]

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