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FDA approves 1-a-day AIDS pill

Posted by pozlife on July 16, 2006

July 13, 2006, 1:22PM

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Houston patients infected with HIV could start taking a one-a-day AIDS “cocktail” as early as next week, according to the U.S. Food and Drug Administration, which announced its approval of Atripla tablets Wednesday.

The availability of the drug, which combines three drugs made by two companies, was applauded by doctors and patients who say it will improve treatment and quality of life by making it easier to adhere to a life-saving medication regimen.

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“This has been the holy grail of HIV treatment, really,” said Dr. Mark Kline, chief of retrovirology at Texas Children’s Hospital. “They’ve taken three drugs that, individually, are very, very good drugs, well-tolerated, safe and potent. This has been a long-sought-after goal.”

AIDS activist Keith Folger of Washington, D.C., who started on 36 pills a day about 11 years ago, said he plans to switch to the new pill. He recalled having to take pills every 2 1/2 hours and how some of them often stuck in his throat.

“It was just awful. Now all a doctor is going to have to say is, ‘I want you to take one of these before you go to bed,’ ” said Folger, who is leaving a position with the National Association of People with AIDS. “How easy is that?”

The drug also is expected to be a powerful weapon in the global AIDS fight, said U.S. Health and Human Services Secretary Mike Leavitt, who called it a “key breakthrough” in an FDA news release. Simplified drug regimens are easier to stick to, and, therefore, more effective and cheaper – an important consideration for developing nations hardest hit by HIV.

Atripla is a combination of drugs already on the market: Sustiva, made by Bristol-Myers Squibb, and Truvada, a drug from Gilead Sciences (actually a combination of two Gilead drugs called Viread and Emtriva).

Unprecedented alliance

The historic collaboration is the first of its kind in the field of HIV/AIDS, the FDA said. Bristol-Myers Squibb and Gilead formed a joint venture to commercialize the drug in the United States. Atripla was approved in three months under the FDA’s fast-track program.

The price of the new drug will be the sum of the components, or about $1,100 for a month’s supply, a spokeswoman for Gilead said. She said health insurance programs are expected to reimburse for Atripla at the same level as other HIV medications. In addition, the companies will work with public health programs, such as the Harris County Hospital District, to ensure low-income patients have access to the pill.

Dr. Roberto Andrade, a Baylor College of Medicine assistant professor who works with HIV patients at the hospital district’s Thomas Street Health Center, which sees about 4,000 patients a year, marveled at the drug companies’ cooperation. He said the effort created an unprecedented advance in terms of scaling back drug quantity unseen in any other medical field he could think of.

“Everybody benefits,” Andrade said. “We believe the best therapy for HIV is the therapy patients will take.”

Resistant HIV strain

Carl Mayberry, a physician assistant who works with Houston HIV specialist Dr. Joseph Gathe, who has a practice of about 2,500 patients, said patients have expressed an interest in the new pill.

He predicted Atripla will work best in people already taking the separate components or those just starting treatment. He said Houston physicians will need to be careful because 10 percent of newly infected individuals have a strain of the virus that is resistant to one of the drugs. Kline said the pill could be particularly useful for his young patients sensitive about standing out from their peers.

“Adolescents don’t want to be different in any way, and taking medication multiple times a day makes them different than other people their same age,” Kline said. “The easier the therapy, the less of an infringement on their sense of normalcy and the more likely they are to adhere.”

There are more than a million people living with HIV/AIDS in the United States, and approximately 16,000 in Harris County, according to the Houston Department of Health and Human Services.

leigh.hopper@chron.com

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