Wall Street Journal - Monday, 27 January 1997.
Michael Waldholz, Staff Reporter of The Wall Street Journal

AIDS researchers presented the first formal studies supporting the unprecedented medical advances, as well as troubling limitations, attributed to the combination drug therapies put into use early last year. Among the most provocative reports presented at the AIDS research meetings that ended yesterday in Washington:

• The first significant decline in AIDS deaths was reported in New York City.
  
  
• Patients in very advanced stages of disease can benefit dramatically from the new drug "cocktails."
  
  
• People treated within months of being infected experienced a sharp, long-lasting reduction in virus in their blood and in tissue elsewhere in their body.
  

Especially surprising to those attending the conference was research from New York City's Department of Health showing that in 1996, AIDS-related deaths fell 30% to 4,944 from 7,046 the year before, the first significant decrease since the reporting of AIDS deaths began in 1983.

"I was very surprised when I first started seeing the decreases last spring because it was just so unexpected," said Mary Ann Chiasson, a city researcher. She presented her study on Friday to the Fourth Conference on Retroviruses and Opportunistic Infections, an annual sharing of formal research studies that this year attracted about 2,300 researchers, doctors, activists and journalists to the nation's capital.

Ms. Chiasson said she believed the decline was because of greater access to new antiviral therapies and health services as a result of increases in government funding beginning in 1995. The drop-off wasn't likely the result of the new protease drugs because they didn't become widely available until late last spring, she said.

But others disagreed. Of particular interest, they noted, was that the daily death rate in October 1996 fell to 10.1, the lowest in years, and half of the average rate of 20.9 in October 1995. "I'd guess the new drugs contributed to that," said Martin Hirsch, an AIDS research physician at Harvard Medical School.

Indeed, yesterday, Dr. Hirsch produced the first data suggesting that people long-infected with HIV also can benefit from the new drug combinations. In a study that followed 320 long-infected patients for six months so far, about 65%, or 55 of 85, of those who took a three-drug combination had their virus levels in the blood fall below the point where it was detectable by the most sensitive tests available.

The patients all had levels of important immune system cells below 50; healthy people have cell counts of 800 or more. Those who received the three drugs -- Glaxo Wellcome PLC's AZT and 3TC, combined with Merck & Co.'s protease drug, Crixivan -- experienced an average rise of 84 cells. Only 2% of patients who received just Crixivan and none of the patients who received just a combination of AZT and 3TC had undetectable virus levels.

"If you had told me last year that even people at this late stage can do well, I'd have been very surprised," Dr. Hirsch said. He said an important aspect of the study was that none of the test subjects previously were resistant to the AZT-3TC combination when they enrolled. "You can't put a protease drug on top of failing therapy," Dr. Hirsch said.

Researchers also reported that 18 of 21 patients on the same triple-drug combination but less further along in the disease had their virus levels kept below detection for more than 68 weeks, the longest anyone has reported a sustained success for the combination therapy. "If you can get the virus all the way down, you can keep it down a long time," said Emilio Emini, Merck's top AIDS research scientist.

In another, much-anticipated presentation yesterday, Martin Markowitz from the Aaron Diamond AIDS Center, New York, updated the center's controversial experiment to eradicate the virus by treating patients with the cocktail therapies within 90 days of infection. Eighteen of 24 patients who have stayed on the therapy had no detectable levels of virus in their blood, some of whom have been treated for as long as 16 months.

Of particular interest, Dr. Markowitz reported that two patients treated more than a year found a sharp reduction in virus in their lymph tissue, a place where the virus can hide and possibly re-emerge if treatment is discontinued. Dr. Markowitz said the small amount of virus identified wasn't active or replicating, meaning that it was trapped inside cells.

Earlier in the week, David Ho, the Diamond's director, said he believed that after two to three years, these few virus-holding cells may die off, taking the viral particles with them. Only if that happens, he said, will patients be asked if they would like to volunteer to terminate drug therapy and see if the virus is really gone.

The formal research largely backs up reports since early last summer indicating 1996 was a watershed year for AIDS treatment in the U.S. "I'd say what we've been hearing is very impressive, confirming what many doctors are seeing in their practices," said Luc Perrin, an infectious disease expert at University of Geneva, Switzerland.

Dr. Perrin said many patients are experiencing significant declines in the levels of circulating HIV, the AIDS virus, in their bloodstreams by taking combinations of two to four drugs, generally including one of three potent "protease inhibitors" released in 1996.

But, he and others at the meetings said, many HIV-infected people in the U.S. and Europe still aren't benefiting, either because side effects force them to quit therapy, the drugs' high costs put therapy out of their reach, or because virus inside them has developed resistance to some of the drugs. Nobody at the meeting had statistics of precisely how many patients are doing well and how many aren't.

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