Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
The Wall Street Journal - December 7, 1995
Thomas M. Burton, Staff Reporter of The Wall Street Journal
Ritonavir, one of a promising new class of antiviral compounds known as protease inhibitors, currently is about nine months into Phase III clinical trials, the most advanced evaluation of a drug prior to possible Food and Drug Administration approval. These newly published studies were based on the smaller Phase I/Phase II tests conducted to evaluate the medication's safety and efficacy. The results are being published in today's edition of the New England Journal of Medicine.
The Abbott medication showed "extremely potent antiviral activity unprecedented for a single agent" against the AIDS virus, said Martin Markowitz of the Aaron Diamond AIDS Research Center in New York, a clinical investigator on one of the studies. The studies, said Dr. Markowitz, "show that the drug works and is a major player." He said the initial results suggest the Abbott drug's efficacy is comparable to that of another experimental drug being developed by Merck & Co. A Merck spokesman said there haven't been any direct head-to-head studies comparing any of the protease-inhibitor drugs against each other.
A third protease inhibitor medication, saquinavir, made by the Hoffmann-LaRoche Inc. unit of Roche Holding Ltd., was endorsed last month by a FDA advisory committee for possible approval by the FDA.
One study published today evaluated ritonavir on 84 HIV-positive patients, while the other tested it on 62 patients. Among the results, seven patients receiving the highest dosage of ritonavir experienced a median increase of 230 CD4 immune cells per cubic millimeter of blood after 32 weeks. Patients with the most severe cases of AIDS can have cell counts of 50 or less, while many healthly people typically have cell counts of more than 500.
Some medical analysts have been skeptical about the long-term value of the protease-inhibitor class of drugs, noting that the virus causing AIDS tends to mutate. Dr. Markowitz agreed that such drugs may need to be used in combination with other therapies. "It may just be another good member of the team, but it's at least a good draft choice."
In New York Stock Exchange composite trading yesterday, Abbott shares rose $1.375 to close at $41.75.
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