Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
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The Wall Street Journal - February 3, 2000
Michael Waldholz, Staff Reporter
Bristol-Myers Squibb Co. said it is developing a powerful once-daily drug against AIDS that could serve as an anchor in a therapy that would be much easier to use than existing AIDS drug regimens. At an AIDS research conference in San Francisco, the New York drug maker reported promising results from a small human trial of the first protease inhibitor drug that patients would be able to take as two pills just once a day.
The two best-selling protease drugs now used, Merck & Co.'s Crixivan and Agouron Pharmaceutical Inc.'s Viracept require patients to take six to 20 pills a day, divided over two or three different times during the day. The protease drugs are just one of the three or four different medicines that make up the drug "cocktail" that has been so effective in keeping HIV, the AIDS-causing virus, in check for many people. Taken together, the regimen can require patients to take as many as 30 pills a day.
"Anyone treating patients knows that one of the biggest reasons patients aren't fully compliant with their therapy is the number of pills they must take and the number of times a day they must take them," said Ian Sanne, a research physician at Johannesburg Hospital in South Africa. Scientists believe that when patients take only part of their drug regimen, they risk allowing HIV to surface in mutant forms that are resistant to the drugs.
"Everyone wants a simpler dosing schedule," he said. Dr. Sanne presented details of the study of the Bristol-Myers drug to researchers attending the Seventh Conference on Retroviruses and Opportunistic Diseases.
In a small study involving 93 patients followed for 16 weeks, the new drug, in combination with two older AIDS medicines marketed by Bristol-Myers, was as effective as existing combination therapies in driving down HIV levels in patients' bloodstreams to below the point where the virus can be readily detected. The researchers are now following the test subjects to make certain the drugs' effect is durable. The company also is planning a larger study of 632 patients as part of its effort to get the drug approved in the U.S. and abroad. In the small study led by Dr. Sanne, researchers combined the new drug with Videx and Zerit, two other Bristol-Myers products. The company is seeking to develop formulations of those drugs that also could be taken just once a day.
Separately, a team of French researchers also reported at the meeting preliminary evidence of another potential once-daily regimen. That combination included Videx, Sustiva, made by DuPont Co., and an experimental drug, Coviracil, being developed by Triangle Pharmaceuticals Inc., a small publicly traded company in Durham, N.C.
Merck had expected to present a study of a new protease drug it is developing that could be taken twice daily. But the company said it has halted studies of the drug, called MK-944A, because of a kidney toxicity that turned up in laboratory rodents. The company said the toxicity hadn't surfaced in human tests, but the company was halting the trial until the problem can be better understood.
Write to Michael Waldholz at mike.waldholz@wsj.com1
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