By Andrew Pollack
Source: The
New York Times
The first complete treatment for HIV/AIDS that is taken once a day as a single pill is expected to be available soon.
The pill, which combines three drugs made by two companies, would be a milestone in improving the simplicity of treatment for the disease, experts say. It should make it easier for people to take their medicine regularly, which is important for keeping HIV in check.
Only a decade ago, when cocktails of AIDS drugs were first used, patients often had to take two or three dozen pills a day, some with food, some without, some so frequently patients had to get up in the middle of the night. Since then, the regimens have been whittled down to as few as two pills a day, and now, one.
"Going down to one pill a day is amazing," said Keith Folger of Washington, who started on 36 pills a day about 11 years ago and expects to switch to the new pill when it becomes available.
Mr. Folger, who is just leaving a job as director of community mobilization for the National Association of People with AIDS, said the pill would be "remarkable, especially for people who are starting on medication for the first time and are sort of freaked out that they will have to take pills for the rest of their lives."
The new drug is a combination of drugs already on the market - Sustiva, sold by Bristol-Myers Squibb, and Truvada, sold by Gilead Sciences. Truvada is a combination of two Gilead drugs, Viread and Emtriva.
The US Food and Drug Administration is expected to approve the new drug as soon as this week. The agency has until October to act but is expected to do so much sooner, partly because the government has been encouraging companies to do just this sort of collaboration to come up with simpler AIDS drugs.
The companies have not revealed the new drug's name or its price, though they have suggested it will cost roughly the same as Sustiva and Truvada bought separately, which is about $1,200 a month.
There are already other AIDS pills that combine three drugs. One, made by a company in India, was recently approved by the FDA for use in developing countries. But those other three-in-one pills generally contain older drugs and are taken twice a day.
The drugs in the new pill already constitute the most widely prescribed regimen in the United States and one of the most effective.
Doctors and securities analysts expect most people now taking Sustiva and Truvada separately to switch to the new pill.
It is somewhat less certain how many people taking other drug combinations will switch. Some of them will not because the virus in their bodies is already resistant to one of the drugs in the new pill or because they cannot tolerate side effects. Sustiva, also known as efavirenz, can cause unsettlingly vivid dreams and birth defects.
In addition, the new salmon-colored pill is about 1,500 milligrams, the size of a large vitamin pill, and some people may find it difficult to swallow.
Going to a single pill could be especially important in poor countries, where patients have less access to medical care and more people are illiterate or uneducated. The vast majority of the nearly 40 million people in the world infected by H.I.V., the virus that causes AIDS, are in developing nations. In the United States there are about 1.1 million.
Bristol-Myers and Gilead say they will make the new pill available at a sharply reduced price for developing nations, but details are still being worked out. They are negotiating with Merck & Company, which sells efavirenz in those countries under the name Stocrin.
A once-daily treatment did not become feasible until a few years ago, with the development of individual drugs that needed to be taken only once a day.
Still, no one company controlled all the drugs needed for an effective combination. It is rare for rivals to collaborate, though it has been done. Merck and Schering-Plough, for instance, have put two of their drugs into a combination cholesterol treatment called Vytorin.
Executives at Bristol-Myers, discussing in 2003 how to increase sales of Sustiva, came up with the idea of approaching Gilead, which already had two once-a-day pills, Viread, also known as tenofovir, and Emtriva, or emtricitabine. Gilead, based in Foster City, Calif., is now the largest supplier of HIV drugs.
Talks were given further urgency when the FDA summoned the two companies and Merck to a meeting in Washington in April 2004. The government was trying to encourage development of simpler pills as part of the president's plan to provide antiviral treatments to poor countries. The next month, the three companies announced their plan.
But carrying it out was not easy. Simply combining the three chemicals produced a mixture that melted easily.