Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
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Wall Street Journal - September 16, 1997
Michael Waldholz
Based on preliminary research data, the new drug, Sustiva, may help doctors overcome some resistance problems among patients taking the new AIDS drug cocktails.
Sustiva's preliminary success is especially interesting, researchers say, because it was initially developed and put aside in the early 1990s by Merck & Co. DuPont Merck, a joint venture of Merck and DuPont Co. based in Wilmington, Del., resurrected the drug several years ago and has aggressively pushed its development. The drug was given to the first test patients in March 1996, and yesterday DuPont Merck said it already has received the go-ahead from the U.S. Food and Drug Administration to provide a limited supply of Sustiva to desperately ill AIDS patients who have failed other treatments.
At a scientific meeting of the Infectious Disease Society of America in San Francisco, researchers will present data showing that when a single daily dose of Sustiva was combined with Merck's big-selling protease AIDS drug, Crixivan, the two-drug therapy performed about as well as treatments requiring the combined use of three or four drugs.
In their report, researchers will show that after 48 weeks of treatment, the virus levels were undetectable in the bloodstreams of about 80% of 59 patients tested, a success rate about as good as any produced by the new AIDS drug "cocktails" that have revolutionized treatment of the deadly disease since last year. The two-drug combination's major drawback, to date, is that it causes rashes, dizziness and flu-like symptoms for some test patients, the researchers will report.
The new drug cocktails are succeeding in restoring health to many people with AIDS, because they are the first treatments able to drive the amount of virus in the bloodstream to below a point where the virus can be detected. New research suggests that patients whose virus is reduced below detectable levels fare best, and have the greatest chance of not developing resistance to the new drugs.
"Sustiva's principal benefit is that it is a very potent drug, as shown by the fact that it can be given just once a day," said Paul Friedman, president of the DuPont Merck's research operations. He added: "We are moving as fast as we can to get it approved." DuPont Merck hopes to ask the FDA for full marketing clearance next April, Dr. Friedman said.
Research physicians testing new combinations of drugs said they were pleased by news of Sustiva's preliminary results because it may be useful for patients resistant to the currently approved drug combinations. Sustiva is in a class of drugs, called nonnucleoside reverse transcriptase inhibitors, or NNRTIs, that differ significantly from the two main types of medicines in the new drug cocktails.
Currently, most of the powerful new cocktail therapies include a protease drug such as Crixivan combined with a "nucleoside," such as Glaxo Wellcome PLC's drugs AZT and 3TC, or Bristol-Myers Squibb Co. 's drug Zerit.
"We hope Sustiva will give new hope for someone who already is resistant to nucleoside," said DuPont Merck's Dr. Friedman. Currently, Boehringer Ingelheim GmbH, and Pharmacia & Upjohn Inc. already sell medicines that work in the same fashion as Sustiva.
Merck originally discovered Sustiva in 1992, but its research laboratories put it aside to work on developing Crixivan. DuPont Merck was given the drug to develop in 1994, and its potency was identified in 1995 when it was first administered to healthy human subjects. AIDS researchers say Sustiva is one of five experimental drugs expected to gain use as part of the new cocktail therapy over the next year or so.
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