AEGiS-WSJ: Technology & Health: Study Finds Abbott Labs AIDS Drug Cut Fatalities Due to Disease in Half

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Technology & Health: Study Finds Abbott Labs AIDS Drug Cut Fatalities Due to Disease in Half

The Wall Street Journal - 1 Feb 1996
Thomas M. Burton, Staff Reporter of The Wall Street Journal

CHICAGO -- A study of nearly 1,100 seriously ill AIDS patients found that a new Abbott Laboratories drug cut the death rate and progression of disease roughly in half, underscoring earlier findings that the drug increased immune cells and reduced patients' viral level.

In results expected to be made public at a scientific meeting today in Washington, clinical investigators found that 4.8% of the 543 patients taking the Abbott drug Norvir died during the seven-month study, compared with 8.4% of 547 patients not getting the drug. All patients in both groups continued to receive whatever standard therapy they were on before the study began. Norvir is known generically as ritonavir.

Similarly, 13% of the ritonavir patients died or suffered disease progression, compared with 27% of patients getting a placebo. "Disease progression" refers to a number of AIDS-related illnesses such as wasting syndrome and fungal infections. Earlier this week, Abbott and Merck & Co. had presented results of other, separate and much smaller studies showing that ritonavir and a Merck drug, Crixivan, each showed powerful anti-viral activity against the AIDS virus when used in combination with two other standard AIDS drugs. Those trials measured immune-cell counts and amount of virus in the blood.

But Abbott's latest study focusing on deaths and disease progression is the first such evaluation of the powerful new "protease-inhibitor" class of AIDS drugs that includes Abbott's and Merck's medications. Abbott's drug is expected to be evaluated at a Food and Drug Administration advisory committee meeting Feb. 29. Merck's drug, known generically as indinavir, is scheduled to be considered March 1. The only FDA-approved "protease-inhibitor" drug is Invirase, made by the Hoffmann-LaRoche Inc. unit of Roche Holding Ltd. These drugs inactivate the enzyme protease, a portion of the AIDS virus that's crucial for the virus to replicate itself.

The latest Abbott study "is striking," said Martin Markowitz, a staff investigator at New York's Aaron Diamond AIDS Research Center who helped conduct the Abbott drug trial. "Anybody who doubts ritonavir is revolutionary isn't looking at reality. This study is historic."

Clyde Crumpacker, a Harvard medical school professor who wasn't involved in the study, said AIDS patients still will need to be evaluated over a longer time to fully understand the health effects of any drug. That's especially true with the AIDS virus, various doctors say, because it can mutate, making it especially difficult to combat. But Dr. Crumpacker noted that "in this sick population, these results are significant. Anything that improves survival is hopeful and should not be dismissed."

All patients involved in the Abbott study had advanced AIDS. Their CD4 immune-cell counts were all less than 100 cells per milliliter of blood plasma, meaning they had severely compromised immune systems. Healthy people typically have such immune-cell counts of between 800 and 1,000. Dr. Markowitz said the patients were treated for anywhere from four to seven months.

John Leonard, Abbott's protease project director, said the current study shows a correlation between immune-cell and viral level, on the one hand, and "survival and lessening the progression toward AIDS." The study, he noted, showed that patients in the ritonavir group also had improved viral-level and immune-cell measurements.

"We now know how to design regimens" of multiple drugs, he said, that will extend the benefits of each "to a long period of time that could be years."

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