Los Angeles Times (LT) - MONDAY July 8, 1996 Edition: Home Edition Page: 1 Pt. A Word Count: 748
Thomas H. Maugh II; Times Medical Writer

In a 73-week trial of 940 patients with HIV, the human immunodeficiency virus that causes AIDS, researchers encountered about 70% fewer deaths among patients who received a combination of a new type of drug called a protease inhibitor along with older drugs than among patients who received either type of drug alone.

"The results of this study clearly show the clinical benefits" of combination therapy, Dr. Jacob Lalezari of UC-San Francisco said as the 11th International Conference on AIDS got underway here.

"We are helping (patients) to live longer, as opposed to merely easing pain and other symptoms," said Dr. Brian Gazzard of Chelsea and Westminster Hospital in London.

More than 15,000 scientists, AIDS activists, patients, social service workers and journalists have descended on this British Columbia city for what promises to be a gathering characterized by hope--a dramatic change from the gloomy mood at the 10th conference two years ago in Yokohama, Japan.

Researchers and the public have clearly been buoyed by unofficial reports of successes achieved with the new protease inhibitors--so much so that conference officials felt it necessary to tamp down some of the optimism.

"There is hope, yes, but let's not exaggerate. Let's not switch from very dark pessimism to hype and over-optimism so we will all have a hangover within six months or a year," said Dr. Peter Piot, the head of the U.N. Program on HIV/AIDS.

"We have our first glimmers of hope in a long time," said conference co-chair Dr. Martin Schechter of the University of British Columbia. "We are beginning to have the tools within our grasp to be able to start to chip away at this problem--if we are given the resources and commitments we need from governments and people around the world."

The source of the optimism is a series of new results with the protease inhibitors, three of which have been approved by the U.S. Food and Drug Administration. The new drugs block an enzyme, called protease, that is crucial for viral reproduction.

Individually, the new drugs are no more effective than the older drugs, known as reverse transcriptase inhibitors--among them AZT, ddC, ddI and 3TC. But combinations of the drugs pack a much more powerful wallop.

In one study released here Sunday, researchers found that the protease inhibitor known as saquinavir combined with AZT and 3TC reduced virus concentrations to undetectable levels in 31 of 33 patients.

The treatment also improved CD4 white blood cell counts--a measure of health status--according to Dr. Miklos P. Salgo of Hoffman-La Roche, which manufactures saquinavir under the trade name Invirase.

Similar reports of trials with other combinations of drugs were released unofficially before the meeting, sparking a great deal of enthusiasm. But researchers have never been certain that lowering levels of the virus in the blood and improving CD4 counts would necessarily translate into better health and longer life.

The study released Sunday provides that evidence.

About 80% of the participants in the study had not yet developed full-blown AIDS at the beginning of the research trial, but all had previously been forced to quit AZT therapy because of resistance or side effects. One-third of the 940 participants received ddC (which goes by the trade name Hivid), one-third received saquinavir and the remainder received both.

After 73 weeks, there had been 28 deaths in the ddC group and 34 deaths in the saquinavir group, but only nine among those who received combination therapy.

The combination of drugs also delayed the onset of AIDS symptoms in those who were HIV-positive at the beginning of the study. After 73 weeks, 85 of those receiving ddC had developed an AIDS-defining illness, such as PCP pneumonia or Kaposi's sarcoma. Seventy-seven of those who received saquinavir had developed a similar illness, but only 46 of those who received a combination of drugs had done so.

"This is going to change the way we treat patients," said Dr. Laurent Fischer of Hoffman-La Roche.

But conference co-chairman Michael V. O'Shaughnessy cautioned against over-optimism. "The results are early, the costs (of the drugs) are high and their accessibility remains a problem," he said.

The new drug combinations cost about $16,000 per person per year, Piot said.

CAPTION: Photo: Michael Belefonte, left, and David Pasquarelli of ACT UP demonstrate before opening of AIDS conference. Reuters

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