The Wall Street Journal - July 9, 1996
Elyse Tanouye, Staff Reporter

A panel of scientists and activists who advise the White House on AIDS termed the Clinton administration ''timid'' for failing to support needle-exchange programs1.

The studies suggest the experimental compounds may work as well as a class of drugs called protease inhibitors, attacking the virus at different points. The reports of even more and better drugs in pharmaceutical-company pipelines added to the rising excitement here regarding drug therapy against the virus. Researchers will present data Thursday on a Glaxo Wellcome PLC drug showing surprisingly robust activity against the HIV virus. The drug, tagged only as 1592U89 and a chemical cousin to AZT, apparently reduces virus levels in the blood about as well as the much-discussed protease inhibitors, according to Michael Saag, director of the AIDS outpatient clinic at the University of Alabama at Birmingham, and the lead researcher in the 1592 trials.

Early tests of the drug taken alone resulted in a 100-fold reduction of the virus in patients' blood, comparable to the effect of protease inhibitors (also when taken alone), according to Dr. Saag. AZT (known as Retrovir), by contrast, knocks down the viral load by just fourfold to sevenfold, he said. Moreover, 1592 penetrates central nervous-system sites, such as the brain, something even most new protease inhibitor drugs can't do.

New Questions

Such news of more and better drugs on the way, following close on the heels of news about the protease inhibitors, is encouraging many of the physicians and patients among the 15,000 attendees of the conference to ask questions never before asked in the 15-year fight against AIDS.

One especially provocative question -- can the virus now be eradicated? --has been raised repeatedly by conference leaders and speakers. That's a notion that would have been considered "ludicrous" six months ago, Scott M. Hammer of the Deaconess Hospital and Harvard Medical School told an audience of thousands packed into GM Place, Vancouver's home of its professional hockey and basketball teams.

"The recent advances that we have witnessed ... should spur even more intensive drug development efforts and the testing of even more aggressive therapeutic approaches," predicted Dr. Hammer in a lead presentation at the meeting.

The results of the 1592 study even surprised the researchers working with the drug, University of Alabama's Dr. Saag said in an interview. In the test tube, the drug doesn't look much different from AZT, which led researchers to expect a similar effect on the virus, he said. The company plans to begin late-stage testing of the drug, possibly in combination with a protease inhibitor, in the fall.

The new drug will add to Glaxo's AIDS portfolio, which includes Retrovir and 3TC (Epivir), approved by the FDA late last year. They are fast becoming the standard ingredients of a powerful combination three-drug therapy that includes one of the three protease inhibitors, Merck & Co.'s Crixivan, Abbott Laboratories' Norvir, and Roche Holding Ltd.'s Invirase, that were released for commercial use recently.

Cautious, Growing Enthusiasm

The promise of this new three-drug "cocktail" continued to generate cautious but growing enthusiasm at the meeting here, as almost every session made reference to the new therapy's ability to drastically reduce the presence of HIV, the AIDS virus, in patients' blood. Researchers here say the new combination drug therapies may turn AIDS into a long-term, manageable disease, although scientists are warning that it is far too soon to say this is a cure.

As with Glaxo's 3TC, the new drug also appears to increase the effectiveness of the company's older medicine AZT. The combination of AZT and 3TC is gaining wide use in recent months. Glaxo is working on a version of 1592 that may be taken as a couple of tablets two or three times a day, thus reducing the burden on patients who now may take 18 pills a day in the triple-drug combination therapy, said M. Lynn Smiley, Glaxo's international director of antiviral clinical research.

Glaxo Wellcome also has a protease inhibitor it is developing, which is dubbed 141W94 and was licensed several years ago from a small biotech company, Vertex Pharmaceuticals Inc. of Cambridge, Mass. The Vertex drug, like 1592, also appears to penetrate central nervous-system sites in laboratory animals, according to Dr. Smiley. More importantly, it doesn't appear to result in the same type of drug resistance that develops with other protease inhibitors, raising the possibility that it may work in patients who develop resistance to the other drugs.

A drug being developed by Boehringer Ingelheim, nevirapine, was also described as promising by Dr. Hammer. In a study, after 28 weeks the virus couldn't be detected in nearly 75% of patients who took nevirapine with two other anti-AIDS drugs, Dr. Hammer said.

Adding a particularly impressive stamp to the debate over how best to use the newly emerging combination therapy, the long-time AIDS researcher Robert Gallo told a packed gathering here that the time had come to treat infected people earlier than is currently done. "We must and should treat early and hard, based on the new results' presented in recent months and at the conference this week, he said.

Separately, the conference was alerted by the rising concern that HIV infection was growing with troubling dimensions among young gay men who appear to be practicing a large degree of unprotected sex. John de Wit, a researcher at the University of Utrecht, the Netherlands, called the trend "an individual tragedy" and a "major public health concern" that must be addressed with preventive programs aimed directly at this high-risk group of people.
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