Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
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The Wall Street Journal - November 8, 1995
Laurie McGinley and Anita Womack, Staff Reporters of The Wall Street Journal
Invirase, also known by the generic name saquinavir, is part of a group of drugs called protease inhibitors. They work by blocking the reproduction of the human immunodeficiency virus by disabling protease, a crucial enzyme.
Several companies, including Merck & Co. and Abbott Laboratories, are rushing to develop their own drugs for what is expected to be a heated competition.
And Hoffmann-LaRoche, which is a unit of Roche Holding of Switzerland, is reformulating its drug to try to make it more potent.
The Antiviral Drugs Advisory Committee limited its recommendation for Invirase to patients with advanced AIDS. The panel also said it should be used only in combination with another class of AIDS drugs called nucleoside analogs, which includes AZT, the most widely prescribed AIDS drug today.
When used with some of those drugs, Invirase provided moderate improvements but didn't provide benefits when used alone, the panel said.
FDA Commissioner David Kessler, who has indicated the agency would give quick approval to the new type of drugs, called the panel's action an important step. As a group, he said, the protease inhibitors "are the most active agents we've seen" in a long time. The current version of Invirase, he said, is "inferior to what we'll see down the road," but not to what is currently available for AIDS patients.
While the news is encouraging, serious problems remain. For one thing, protease inhibitors don't offer a cure. Moreover, there are concerns that they may cause the AIDS virus to mutate and become resistant. This, in turn, could cause "cross-resistance" so that a patient who uses one protease inhibitor might not be helped by a superior one developed later. Government researchers said yesterday there isn't enough data to determine how serious a problem that would be.
Some leading analysts doubt the longterm value of the new drugs. "I'm skeptical," said Hemant Shah, a drug analyst for HKS & Co., Warren, N.J. "The problem with the HIV virus is that it tends to mutate into another form constantly, and that's why we have had problems with all AIDS drugs." But David Gilden, editor of "Treatment Issues," a monthly publication by the Gay Men's Health Crisis, called protease inhibitors "an important new strategy" that could help achieve stabilization of AIDS in some patients.
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