DATE: Tuesday, September 30, 1997           TAG: 9709300255

SECTION: FRONT                   PAGE: A1   EDITION: FINAL 

SOURCE: ASSOCIATED PRESS 

DATELINE: TORONTO                           LENGTH:  100 lines

AIDS DRUG ``COCKTAILS'' FAILING IN HALF OF CASES NEW DATA SUGGEST THE VIRUS IS RETURNING AFTER BEING KNOCKED INTO BRIEF SUBMISSION.

Widely heralded new AIDS treatments that seemed to stop the virus' advance and revive patients from near death are now beginning to fail in about half of all those treated, doctors said Monday.

The disappointing reports suggest the tough virus is coming back after being knocked briefly into submission, just as many experts feared it would.

``Over the past year, we had a honeymoon period,'' said Dr. Steven Deeks. ``The epidemic will likely split in two, and for half the people we will need new therapeutic options.''

Deeks presented data from the University of California at San Francisco's large public AIDS clinic at San Francisco General Hospital. He made the presentation at an infectious disease conference sponsored by the American Society of Microbiology,

Prescriptions of so-called three-drug cocktails - two older AIDS drugs plus one of the new class of medicines called protease inhibitors - have clearly revolutionized AIDS care. In many places, more than 90 percent of AIDS patients are taking these combinations, and typically people start on them as soon as they learn they are infected, even before they get sick.

Patients whose disease-fighting T cells were ravaged by HIV have gotten out of bed, regained normal lives and even gone back to work. However, many worried from the start that the virus would eventually grow resistant to the protease inhibitors and resume its insidious destruction.

The latest data suggests this is indeed happening regularly.

Deeks and colleagues reviewed the records of 136 HIV-infected people who started on protease inhibitors in March 1996, when Crixivan and Norvir, the first two powerful protease inhibitors, came on the market.

Most patients responded dramatically. Their virus levels dropped so low they could not be found on standard tests. But since then, the virus has returned to detectable levels in 53 percent.

Although this is ominous, no one knows exactly what it means.

``All of our `failures' are clinically feeling very well,'' said Deeks. ``It's very important to understand we have no idea of the prognosis of people who have resistant virus.''

There is a whole mixture of explanations'' for the failures, said Dr. David Ho of the Aaron Diamond AIDS Research Center in New York City.

Ho said that for people who had relatively low virus levels when they started taking the drugs and had not used other AIDS medicines, failure almost always means they did not take their pills on schedule. Even missing a few doses can ruin the treatment.

``Compliance is absolutely critical,'' Deeks said. ``When we say compliance, we mean rigid adherence to over 20 pills a day.''

Also at high risk of failure are those who were on other AIDS drugs before starting protease inhibitors or whose T cell counts were very low.

Deeks said his data are far different from the carefully controlled drug experiments sponsored by pharmaceutical companies to demonstrate the medicines' potential. These studies show far more encouraging results.

Among the longest-running of these is a study of 28 patients who have been taking Crixivan, AZT and 3TC. Dr. Roy Gulick of New York University said Monday that after almost two years, the virus is still undetectable in 22 of them, or 79 percent.

Deeks said real-world experience is not as promising as the trials because patients in the studies are less sick to start with and more highly motivated to scrupulously follow their drug regimens.

Also presented Monday was the first large study of the use of protease inhibitors in children. Just over half appeared to be responding well after three months of therapy.

In other developments, the first combination pill for AIDS therapy could allow patients to cut six tablets a day from their complicated drug regimen.

Glaxo Wellcome announced Monday that the Food and Drug Administration has approved Combivir, combining two of the most common AIDS medicines - AZT and 3TC - into one tablet.

Powerful anti-HIV drug cocktails often require patients to take as many as 20 pills a day at precise times. Combivir would let patients take two tablets a day instead of the up to eight pills required when taking AZT and 3TC separately, the FDA said.

The drug will be on pharmacy shelves by mid-October, and the annual wholesale price of $5,240 will be similar to AZT and 3TC taken separately.

In a second development, researchers say they have increasing evidence that a deficiency of the mineral selenium - found in foods including whole grains, seafood and liver - can dramatically lower the survival rate of people infected with HIV.

Scientists say the mineral plays a key role in maintaining a healthy immune system, and has been shown to fight cancer.

A study at the Center for Disease Prevention at the University of Miami's School of Medicine showed that HIV-infected patients with a deficiency of selenium were almost 20 times more likely to die of causes related to HIV.

The study of 125 HIV-infected men and women, published today in the Journal of Acquired Immune Deficiency Syndrome, demonstrated that selenium plays a critical role in the progression of AIDS. ILLUSTRATION: Graphic with color photo

THE DRUGS

So-called three-drug cocktails - two older AIDS drugs plus one of

the new class of medicines called protease inhibitors, pictured

above - have revolutionized AIDS care. In many places, more than 90

percent of AIDS patients are taking these combinations.

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