Once-a-Day AIDS Pill Could Be Ready Soon

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January 19, 2006

Two drug companies say they've put aside commercial rivalry to achieve a goal that seemed out of reach for 20 years: a single-pill, once-a-day AIDS treatment.

The pill is to contain a regimen of three drugs already available on pharmacy shelves and shown to be effective in multiple studies, including one coming out today in the New England Journal of Medicine. Barring last-minute problems in formulating the pill, doctors expect it to be approved by the end of the year.

If that happened, it would be a milestone in the development of treatments for the human immunodeficiency virus, which causes AIDS. The virus has infected 1.1 million people in the United States and more than 40 million around the world, the vast majority of those in poor countries.

When effective AIDS treatments were first devised in the 1990s, patients sometimes had to wake up in the middle of the night to take regimens consisting of 50 or 60 pills administered several times a day with complicated food restrictions. Back then, a once-a-day pill seemed a distant mirage, but doctors have long said it would be a big help in getting more people onto treatment.

Under heavy pressure to simplify treatment regimens, companies have been combining medicines and reducing pill counts for several years. Yet for commercial, rather than scientific, reasons, no company has yet managed to create a single once-a-day pill containing an effective combination of AIDS drugs. As it happened, no single company owned the rights to all the drugs necessary for an optimal combination, and the companies were wary of working together.

Now two companies say they have combined into one salmon-colored pill the three licensed AIDS drugs that already make up the most-prescribed drug regimen for newly diagnosed HIV patients. The companies recently announced data showing the pill can achieve adequate blood levels of all three drugs, and today's study in the New England Journal of Medicine adds to a large body of evidence showing the drug combination is effective with relatively few side effects. The companies are already producing test lots of the pill at a plant in Ontario.

The Food and Drug Administration readily blesses new, more convenient formulations of previously licensed drugs, and approval of the new pill, though it will take several more months, is expected to be routine. The biggest hurdle at this point is making sure the pills have an adequate shelf life, a problem the companies say they are confident they can solve.

"I think it's a huge thing these companies are going to do," said Nelson Vergel, an AIDS treatment activist in Houston. "If they give it at the right price to developing countries, it's going to become the main treatment in the world."

The companies involved, Gilead Sciences Inc. and Bristol-Myers Squibb Co., say they are indeed committed to providing the treatment to poor people overseas. But their immediate goal is to get it on the U.S. and European markets by the end of this year. If the pill, which doesn't have a name yet, can capture a bigger slice of the market, the potential profit is huge. While the companies have yet to announce a price, some AIDS regimens can cost upward of $30,000 per patient per year.

The Gilead-Bristol collaboration required a year of complex negotiations, with lawyers involved at every step to make sure the erstwhile competitors didn't run afoul of antitrust laws. And repeated tests were needed to get a pill with the right formula to achieve good blood levels.

It's the first such collaboration, but it probably won't be the last.

With nearly two dozen AIDS drugs on the market, with many more on the way, and with the patients taking them expecting to live out normal life spans, companies say devising convenient regimens has become a make-or-break problem. Each company's initial strategy was to combine only treatments it owned, but the firms say commercial pressure is forcing them to cross company lines.

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.
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