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New Drug Combination to Be Tested in People to Block AIDS Virus

Posted on: Thursday, 11 May 2006, 21:05 CDT

SAN JOSE, Calif. _ A drug made by Gilead Sciences showed so much promise protecting monkeys from getting the AIDS virus that scientists want to test it in people in at least three countries to see if it can help slow the global AIDS epidemic.

Because of the success of Gilead's Truvada on six monkeys, scientists say they are planning tests of Truvada in a U.S. location still to be picked as well as in Peru. The U.S. Centers for Disease Control has already announced it would test the drug on people in Botswana, beginning in about five months.

Truvada is a combination of two Gilead drugs already used to treat people infected with the AIDS virus.

The federal agency already is conducting studies in Thailand, San Francisco and Atlanta, to see people can be shielded from the AIDS virus by one of the drugs in Truvada _ Viread, also known as tenofovir. Other studies of Viread as a preventive, overseen by the non-profit Family Health International, are being done in Africa.

But given the monkey study, researchers want to determine if better protection can be offered by Truvada, a combination of Viread and the second Gilead drug, Emtriva.

The Peru study involving 1,400 gay men could start as early as this year and be completed by 2008 or 2009, according to its principal investigator, Dr. Robert Grant, director of the Gladstone Institute of Virology and Immunology in San Francisco.

When the study initially was financed by the National Institutes of Health in 2004, Grant said he tried to convince the agency to use Truvada, which was approved that year by the U.S. Food and Drug Administration for treatment of AIDS. Because Truvada was a combination of two drugs, it seemed likely to be more effective than a single drug and less likely for patient to grow resistant to it, Grant said.

Although the NIH chose Viread only at the time, Grant said he's optimistic the agency will agree to switch to Truvada. With the new monkey data, he said, "it becomes easier to convince everyone" that Truvada is worth trying.

However, he cautioned that the monkeys in the study were injected with Truvada, while human subjects would be given the drug orally and in a lower dose. Moreover, he said, monkeys metabolize drugs differently than people. So it's hard to predict whether Truvada will turn out to be better at warding off the AIDS virus.

Because they're not involved in the studies, Gilead executives have been cautious about discussing the monkey data and the possibility that Truvada could prove an effective shield against the AIDS virus. But in an interview this week, John Martin, Gilead's chief executive, said he was pleased with the growing popularity of Truvada, which is sold as a treatment for people already infected with the AIDS virus.

"We have an increasing share of the patients being treated," Martin said, adding, "the market is growing."

Truvada sales totaled $248.9 million for the first quarter of this year, a 173 percent increase from the first quarter of 2005, and the drug now accounts for about 45 percent of all Gilead's product sales.

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(c) 2006, San Jose Mercury News (San Jose, Calif.).

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Source: San Jose Mercury News

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