Associated Press - Wednesday, October 28, 1998
Janet McConnaughey, Associated Press Writer

Over the past few years, the three-drug AIDS "cocktail" has turned AIDS from a death sentence to a manageable illness. However, patients must take their pills on an excruciatingly precise schedule. Some pills must be taken with a quart of water, some on an empty stomach, some only after eating. Missing a few can let the virus mutate into forms resistant to the drugs.

In two studies published in Thursday's New England Journal of Medicine, researchers tried to find out what would happen if they cut back on patients' medication once the drugs had reduced the virus to almost undetectable levels. It's the way cancer is treated: hit it hard and fast at the start, then follow up with easier-to-take maintenance therapy.

Doctors in France and the United States took different approaches but got results so disappointing that both studies were ended early.

In the United States, virus levels shot up rapidly in nearly one-quarter of the patients whose medication was cut back to just one or two of the drugs.

"Most failed in the first couple of weeks," said Dr. Diane Havlir of the University of California at San Diego, lead author of the U.S. study, which treated 316 people at 27 centers.

The U.S. patients took all three drugs for six months, then were divided into three groups. One group got all three drugs. The second group got only Crixivan, the most popular protease inhibitor. The third group got the two older drugs, AZT and 3TC.

All three groups continued taking the same number of pills, but some of them were placebos, or dummy pills.

In the French study, led by Dr. Gilles Pialoux of the Pasteur Institute Hospital, 279 patients at 34 centers took all three drugs for three months. After that, one-third continued with all three, and two other groups took AZT and either Crixivan or 3TC.

Only 4 percent of the U.S. patients and 9 percent of the French patients taking all three drugs had more virus in their blood when the studies ended than they did after the first three or six months.

But 23 percent of each of the two other U.S. groups showed signs of viral rebound. In France, that happened to 31 percent of the patients on AZT and 3TC, and to 22 percent of those on AZT and Crixivan.

All of the patients were treated as soon as they learned they were infected, before symptoms appeared. That is standard with the AIDS cocktail.

Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said it is too early to assume that people must stay on the drug cocktail for the rest of their lives.

While these studies show that patients cannot be put on fewer drugs after three or six months, Fauci said a year might do the job.

Doctors at Massachusetts General Hospital and at Fauci's center are even testing whether someone who has had no detectable virus in the blood for a year can go off the drugs entirely.

"I say, if we want to treat it early and treat it hard, we should treat it longer before switching to a less toxic regime," Fauci said. "Three months or six months is really cutting it close."

Dr. Robert Siciliano, an AIDS researcher at Johns Hopkins University, said the studies show that current drugs are barely keeping the AIDS virus under control.

"As soon as one drug is dropped, we immediately see that they start to fail. So we need more potent drugs," he said.
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