Once-a-Day AIDS Pill Could Be Ready Soon

By Justin Gillis
Washington Post Staff Writer
Thursday, 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.

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