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Study Backs AIDS Drug Combo

Associated Press

By LINDSEY TANNER AP Medical Writer

Tuesday, March 6, 2001

CHICAGO (AP) - An AIDS cocktail without a protease inhibitor - the drug that has transformed the disease from a death sentence - appears to suppress the virus just as well, offering a potential alternative to patients who have become resistant to treatment, researchers say.

The study compared results in patients treated with a standard AIDS cocktail containing a protease inhibitor to those treated with a combination of three medicines known as nucleoside analogs.

The research was funded by Glaxo Wellcome Inc., maker of the nucleoside analog Ziagen, approved in 1998.

The study found that patients treated with a nucleoside cocktail containing Ziagen fared as well as those treated with a combination of two nucleosides plus a protease inhibitor. After 48 weeks, 51 percent of patients in both groups had reduced the amount of virus to the standard, desirable level of 400 or fewer copies of HIV per milliliter of blood.

However, many AIDS experts favor suppressing the virus to under 50 copies per milliliter. And the protease cocktail proved superior at getting the virus down to this level in patients who started out with the highest amounts of virus in their blood.

The study of 562 HIV-infected patients is published in Wednesday's Journal of the American Medical Association.

The study was led by Dr. Schlomo Staszewski of Johann Wolfgang Goethe University in Frankfurt, Germany. He collaborated with researchers at 73 centers in the United States, Canada, Australia and Europe.

Protease inhibitors, introduced in the mid-1990s, revolutionized AIDS treatment, transforming the disease into a manageable chronic ailment for many patients. The drugs typically are mixed with two other, older medicines such as the nucleoside analogs AZT and 3TC.

But because the wily virus can quickly mutate and become resistant to medication, the drugs in patients' cocktails must be frequently switched to remain effective.

Dr. Jeffrey Laurence of Cornell University, senior scientific consultant for the American Foundation for AIDS Research who was not involved in the study, noted that the research looked only at patients who had not previously taken antiviral drugs.

Still, he called the study ``a reasonable piece of information, something to think about if you're concerned about inducing resistance to protease inhibitors and want to keep something in reserve.''

In the study, patients took cocktails containing AZT and 3TC plus either Ziagen or Merck & Co.'s protease inhibitor Crixivan.

Ziagen is sold with a warning that in rare cases, it can cause severe and sometimes fatal allergic reactions. In the study, one patient died from an allergic reaction to Ziagen. But otherwise, the side effects were similar in the two groups.

The researchers said the risk of allergic reactions and lack of data on the long-term effects of Ziagen cocktails should be considered when weighing treatment options.

Recent research found that yet another non-protease cocktail might also be a good alternative.

On the Net:

JAMA: http://jama.ama-assn.org

National Institutes of Health: http://www.niaid.nih.gov

Copyright 2001 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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Last updated: 07 March 2001