Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Reuters NewMedia - Tuesday September 28, 1999

The drugs stop the AIDS virus from ever getting into cells in the first place. They are still experimental and must be injected twice a day, but early studies show they can work, the researchers said.

Dr. Jay Lalezari and colleagues at Quest Clinical Research in San Francisco tested 55 patients whose cocktail regimens had started to falter. He gave them an experimental fusion inhibitor known as T-20 along with other HIV drugs.

"There is an urgent unmet need for new treatment options that are effective in the ever-growing number of HIV-infected patients who have cycled through available drugs," Lalezari said in a statement.

REDUCED HIV IN BLOOD

Durham, North Carolina-based Trimeris, Inc. and partner F. Hoffmann-La Roche, which make T-20, said that 33 of 55 patients who got the drug, or 60 percent of them, saw a clinically significant reduction of virus in their blood.

All the patients had tried various cocktails of drugs but suffered a comeback of the virus. Multiple combinations of HIV drugs have been shown to suppress the virus so strongly that it sometimes seems to disappear.

But researchers at a meeting here sponsored by the American Society of Microbiology have complained that many patients are starting to see the virus come back despite the mixtures. They have been urging the development of new drugs, as well as a vaccine, which is seen as the only long-term answer to the AIDS epidemic.

"The study results are exciting because the response rates exceeded what is normally observed in this advanced and heavily pre-treated patient population," Lalezari said.

The patients had been on the drug for as long as four months. Other researchers commented that they all put up with the twice-daily injections of the drugs -- something that had been seen as a stumbling block.

"No patients discontinued the trial due to T-20-related adverse events or intolerance of the twice-daily subcutaneous injection," said Sam Hopkins, senior vice president of medical affairs at Trimeris.

PHASE III TRIALS AHEAD

Hopkins said the company would now move to Phase III trials meant to show just how well the drug works. They are the last step a company must take before seeking Food and Drug Administration (FDA) approval.

"Because T-20 attacks the HIV virus before it enters the cell, it works differently than currently approved anti-HIV drugs. It therefore has the potential to combat strains of the virus that have become resistant to these treatments," Dr. Michael Saag of the University of Alabama at Birmingham said. Trimeris is working on a second fusion inhibitor, T-1249.

It has received fast-track designation from the FDA and is in Phase I testing for safety.
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Always watch for outdated information. This article first appeared in 1999. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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