Once-a-Day AIDS Pill Could Be Ready Soon

AIDS treatment activists once marched in the streets and broke windows at the FDA to demand treatments. Today, they sit on committees advising the government and the pharmaceutical companies. Listening to them in 2003, a man named Kevin Trapp, a strategist for New York-based Bristol-Myers Squibb, realized that a medicine controlled by his company could be combined with two other drugs controlled by Gilead, of Foster City, Calif. The result would be the first-ever once-a-day pill.

"They said, 'Companies should be working together,' " Trapp recalled yesterday from a conference in Paris. "The best thing to do is listen to the customer."

Gilead has already combined its two drugs into a single pill, so the three-drug regimen is available today as two pills taken once a day. It doesn't sound arduous, but even for people taking just two pills, the idea of a one-pill-a-day treatment holds some kind of symbolic appeal. "I'm counting the days" until the new pill becomes available, said Lucky Santana, a medical worker in Atlanta who is already on the two-pill combination.

It isn't just that people hate swallowing pills; they hate swallowing the co-payments at the pharmacy that go with the pills, and those can run $50 a month for every prescription. Santana expects to save $30 every time he fills a prescription when the new pill becomes available. "That's a tank of gas nowadays," he said.

The regimen in question consists of three drugs sold separately under the brand names Sustiva, Viread and Emtriva. The three-drug regimen is already the one most commonly prescribed for new HIV patients starting treatment, with nearly 20 percent of the market, according to figures from HIV Therapy Monitor, a data service from Synovate Healthcare Inc., a London research company. The runner-up regimen commands about 11 percent of the market, Synovate data show.

A New England Journal of Medicine study being published today, led by Joel E. Gallant of Johns Hopkins University, shows the three-drug combination to be slightly more effective than the runner-up regimen. It is clear, however, that the once-a-day pill won't be right for every patient.

After several years of an AIDS regimen, the virus in a patient's body can develop resistance. Patients who have been on treatment for years often need to switch to more complex regimens than the one in the once-a-day pill. The pill won't be ideal for women of child-bearing age, since it may cause birth defects. And one of the drugs in the regimen can cause a bizarre side effect that bothers some people: exceedingly vivid dreams. "It's like you are there," said Santana, the Atlanta medical worker.

Norbert W. Bischofberger, executive vice president for research and development at Gilead and the man spearheading the one-a-day project, said his company was "fully committed" to offering the pill at sharply reduced prices in developing countries, noting that it could be a boon for patients without the background to understand a complicated drug regimen.

The new pill, however welcome, won't eliminate pressure to develop even simpler AIDS regimens.

"Somebody is going to have to try in the future to come up with something that's once a week," Santana said.