A once-daily pill becomes option for HIV/AIDS patients

FDA approves combination drug after accelerated 3-month review


WASHINGTON -- AIDS and HIV patients, who have been seeking ever simpler treatments since struggling with a complicated regimen of as many as 25 pills a day a decade ago, can now take one daily pill.

The new pill, Atripla, was approved yesterday by the Food and Drug Administration after an accelerated three-month review reflecting the major public health benefits anticipated by activists, doctors and health officials.

Dr. Andrew C. von Eschenbach, the acting FDA commissioner, hailed the combination drug as a "landmark" that would "fundamentally change treatment" of acquired immune deficiency syndrome and the virus causing it.

Since the difficult early days of treatment, AIDS cocktails have become simple enough that some patients swallow just a few medications a day. Atripla melds three widely prescribed drugs that have been available for several years and are often taken together.

Whittling the daily regimen to one vitamin-sized pill will increase the number of people who take their medication every day in compliance with directions, thereby reducing the AIDS virus' resistance to treatments, experts said.

Studies show that AIDS/HIV patients follow their daily regimen only 80 percent to 90 percent of the time. That is considered a danger because drug resistance is most likely to develop among patients taking their medicines appropriately at an 87 percent rate.

"Resistance is a major problem," said Dr. Rowena Johnston, director of research at amfAR, the Foundation for AIDS Research in New York. "It means people are switching regimens and people newly infected are already resistant to these drugs, so [Atripla] really is a huge boon."

The new drug was also praised for its great potential treating people with HIV/AIDS in Africa and developing countries, where the need for multiple medications is made all the more complicated by the difficulties in storing drugs and administering therapies.

More than 1 million Americans may be infected with the human immunodeficiency virus. About 73,000 have been taking the three drugs that make up Atripla, according to Gilead Sciences, the manufacturer of two of the drugs, Emtriva and Viread; Bristol-Myers Squibb makes the third, Sustiva.

Activists and researchers expect that most of those patients will switch over to the combination pill. What remains uncertain is how many other patients will follow.

"I think there will be a significant amount of switching going on," said Martin Delaney, founding director of Project Inform, an advocacy group in San Francisco. He expects that many people taking other kinds of AIDS drugs, such as protease inhibitors, will also switch.

Protease inhibitors can have serious side effects, such as heightened risks of diabetes. Atripla's worst possible side effects include acid buildup in the blood, liver toxicity and depression. A 48-week study showed it worked well in 80 percent of the test's 244 participants, the FDA said.

The shift to the new drug will be helped because it is no more expensive than the trio of drugs it replaces, activists said. The wholesale price of the new pill will be the sum of its three constituent drugs, $1,150 a month, according to its manufacturers.

"If you have to take five different pills, five different times a day and you forget, you could really be in deep trouble, so the idea of one pill, once a day - we've been really looking forward to it," said Lynda Dee, executive director of AIDS Action Baltimore.

Researchers and activists described the prospect of a single daily pill as a significant and welcome change from the days when people took so many pills under so many directions that they needed timers and crib sheets to keep track of everything.

Yet they worry that the anticipation and relief greeting Atripla will lessen both the fear of contracting AIDS and the vigilance of the sexually active who need to continue guarding against it.

"I'm concerned that people will see the advertisements that say one pill once a day and think that that's easier than wearing condoms," said Dr. Joel Gallant, associate director of the Johns Hopkins AIDS Service. "We need to get the message out that it's still a lot better - it's easier - to prevent than treat even with better therapy."

Maryland has about 30,000 cases of HIV and AIDS. Linda Anders, who oversees the provision of AIDS drugs to 3,500 low-income Marylanders, didn't expect much switchover from patients and doctors happy with current treatments.

"It's not like there will be a new flock of people," said Anders, chief of the Center for Client Services at the Maryland AIDS Administration. A state advisory panel is expected to decide later this month whether to add Atripla to the list of drugs covered by Maryland's state health plans.


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