Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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The Wall Street Journal - July 8, 1996
Michael Waldholz, Staff Reporter of The Wall Street Journal
The 15,000 people attending the conference will be provided data from more than a dozen clinical trials showing that a new class of drugs -- called protease inhibitors -- in combination with an older set of medicines can reduce levels of the AIDS-causing virus in blood to where even the most sensitive tests can't detect them. The data, while still early and from relatively small and short-lived studies, represent a major and unprecedented step in combatting HIV, the virus that causes AIDS, or acquired immune deficiency syndrome.
"We are at a crossroads in the AIDS pandemic," said Martin Schecter, co-chair of the conference and a longtime AIDS researcher at the University of British Columbia. "For the first time we are seeing glimmers of hope" as a result of the drugs' therapy.
Dr. Schecter said the optimism should be "tempered" because the new medicines are very expensive and difficult to take. Dr. Schecter said it is unlikely that the new therapy will soon get to 90% of the estimated 22 million people currently infected with the human immune deficiency virus, or HIV, who live in areas of the world unable to afford or provide the new drugs.
Michael V. O'Shaughnessy, also of the University of British Columbia, said the clinical data aren't yet "conclusive." He added, "The data are not at a point where they show that the drugs are a cure for this disease."
The protease inhibitor drugs are the central ingredient to the new therapies; three of the drugs were approved for use earlier this year in the U.S. When the protease drugs are given in combination with Glaxo Wellcome PLC's AZT, and a handful of similar acting drugs, the new therapy blocks HIV replication to a degree never seen before. The three new protease drugs are Abbott Laboratories' Norvir, Roche Holding Ltd.'s Invirase and Merck & Co.'s Crixivan.
At one meeting yesterday sponsored by Merck, several leading AIDS scientists said the emerging data suggest that doctors ought to begin using the new therapy much sooner after HIV infection is identified than previously considered, a point expected to be debated at length throughout the meeting.
David Ho, director of the Aaron Diamond AIDS Research Center in New York, told a packed audience that results from his research argue for using the new combination therapy as soon as a person is infected. Dr. Ho also said no doctor should be treating any patient with any antiviral drug by itself. He repeated a phrase he has told research groups before, that because of the new drugs it is now "time to hit HIV, early and hard."
Dr. Ho and his colleagues will present one study of 12 newly infected patients using Abbott's Norvir and two other drugs. Nine of the patients who remained on therapy between 90 and 300 days had no evidence of the virus in their bloodstream. The researchers are expected soon to test other tissues, such as lymph nodes, to see if the virus is still lurking there.
In a separate clinical trial, Martin Markowitz, also of the Aaron Diamond Center, will report today that another, not yet approved protease inhibitor, Viracept, that is made by a small biotech company, Agouron Pharmaceuticals Inc., appears as effective in combination therapy as the three drugs already on the market. In the study, 12 patients had no evidence of virus in their blood after four to five months of treatment.
Two other studies will show this week that if viral levels in blood can be knocked way down, the effect may last at least a year. This suggests the virus isn't able to generate resistance if attacked with high doses of the combination therapy, as much as 20 pills, taken daily. Roy Gulick of New York University will report that most of 26 patients given Merck's Crixivan and two other drugs had no detectable virus for as long as they were on the therapy, a period that lasted as long as 48 weeks for some patients.
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The World-Wide Aids Toll
Cumulative, since AIDS was recognized in 1982 and HIV in 1983.
HIV infections: 28 million Aids cases: 7.7 million Aids-related deaths: 5.8 million
Source: Francois-Xavier Bagnoud Center for Health and Human Rights; Harvard University School of Public Health
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