FDA Clears Once-a-Day AIDS Drug

By Marc Kaufman
Washington Post Staff Writer
Thursday, July 13, 2006

The world's first single-pill, once-a-day AIDS treatment was approved yesterday by the Food and Drug Administration -- a medication that experts say will make it easier for infected people to keep the virus under control.

Developed in an unusual cooperative venture by the makers of two rival drugs, the new combination pill, called Atripla, marks a milestone in the treatment of AIDS. While patients used to take 10 or more pills a day, they will now be able to control their disease with one medication.

"This is a landmark for those suffering with HIV and AIDS," said acting FDA Commissioner Andrew von Eschenbach. People will be more likely to take a single pill consistently than several of them, he said, and "compliance with therapy is as important as the therapy itself for a successful outcome."

Deputy FDA Commissioner Murray Lumpkin, who runs the agency's international and special programs, called approval of Atripla a major achievement. "A single, fixed-dose pill has long been seen as the holy grail of AIDS treatment," he said.

The combination pill will not only keep patients healthier, officials said, but also help slow the development of community-wide resistance to AIDS drugs. If patients do not take the drugs regularly, the human immunodeficiency virus has a better chance of mutating into new forms of AIDS that are not affected by the available medications, first in individual patients and later in others.

At a news conference yesterday, unusual in announcing a new drug approval, the agency officials said the combination pill will first be available in the United States, but the need is greatest in poor nations where AIDS treatment is often unavailable or inadequate. The sometimes confusing directions involved with taking many pills a day -- some on a full stomach and some on an empty one -- has kept effectiveness rates low.

"We know that an HIV-AIDS patient needs to take 95 percent of his or her pills or they won't work," said John C. Martin, chief executive of Gilead Sciences Inc., one of the companies in the Atripla project. "So the fewer pills a patient needs to take, the better the outcome."

Martin said creating the combination pill was difficult, with five failed formulations before the successful one was created. "This is not simply a matter of putting together the three drugs," he said. "They have to be put together in a way that each reacts as it does when it's alone, and that can get complicated."

The new drug will combine the two most prescribed AIDS medications -- Bristol-Myers Squibb Co.'s Sustiva and Gilead's Truvada, which is itself a two-drug combination. Gilead officials said Atripla will cost about $1,100 a month, which is equal to the current cost of taking Sustiva and Truvada. The drug's price in poor nations hit hard by AIDS will be set by Merck and Co., which markets Sustiva under the name Stocrin in developing countries.

Gilead spokesman James Loduca said the company will produce a salmon-colored pill for U.S. distribution and a white pill for sale abroad -- suggesting they will be priced quite differently. The drug will be manufactured in Canada.

Von Eschenbach said the FDA wants to encourage other companies to join forces in developing new drugs. The computer industry learned long ago to cooperate in creating new products, he said, and drugmakers are just beginning to move to that model.

The pharmaceutical industry has been under substantial pressure to simplify AIDS-treatment regimens in particular, and companies have been combining medicines for several years. But until the joint venture that created Atripla was formed, a once-a-day pill proved elusive -- for reasons more commercial than scientific.

The FDA said Atripla will be considered for use in 15 developing countries, many of them in Africa, under President Bush's 2003 initiative to combat AIDS. The five-year, $15 billion program aims to treat at least 2 million infected people.

Many of the AIDS drugs used in the program have patent protection but are made in generic versions by companies abroad -- for sale exclusively in poor nations -- with the approval of the patent-holding company. Several Indian companies in particular are active now in making AIDS drugs, including three-drug combinations, but none has yet produced a once-a-day pill.

There are as many as 40 million people worldwide with HIV or AIDS, and more than a million in the United States. About 40,000 new U.S. cases are reported annually.

The FDA has approved 28 products in the United States to treat HIV infection -- most of them as high-priority applications. The Atripla application was approved after a review of only three months, but FDA officials said the agency worked with the manufacturers for several years before the application was submitted.

FDA approved Sustiva in 1998 and the two Gilead drugs -- Viread and Emtriva -- in 2001 and 2003. Their safety and effectiveness in combination were established in a 48-week clinical study with 244 infected adults. In that trial, 80 percent of the people experienced a significant reduction in their virus levels and a substantial increase in the number of healthy cells that fight against infection.

Combination drugs -- or drug "cocktails" -- are especially useful in treating HIV and AIDS because, used regularly, they can keep the fast-evolving virus from mutating into new, hard-to-treat variations. While Atripla will reduce the number of anti-retroviral pills a patient needs to take, officials said, additional medications to boost the immune system and protect against other infections will often be needed.

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