Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
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United Press International; Thursday, March 05, 1998
Glenn Garelik, UPI Science News
Indinavir, sold as Crixivan is manufactured by its maker, Merck & Co., as part of a triple "combination therapy" that has proved highly successful in the past couple of years in reducing the number of virus in the body and increasing the number of immune cells.
The Food and Drug Administration approved the drug's new status on the basis of two studies of patients that showed significant reductions in actual AIDS-associated illnesses as well.
In a study of 1,156 patients that compared therapy with Crixivan plus two antiviral agents to a combination of the two antiviral agents alone, the group whose medication included Crixivan showed a 44-percent reduction in the number of patients who developed AIDS-associated illnesses or died. The study was published last year in the New England Journal of Medicine.
The second study, which evaluated 996 patients, showed a 69 percent reduction in progression to an "AIDS-defining" illness or death among those who took a drug regime that included Crixivan.
Merck also submitted an update on one of its original studies, which is still ongoing. In it, 90 percent of patients taking triple therapy with Crixivan showed virus levels had dropped to undetectable after 24 weeks. The results were sustained for up to a year.
Crixivan is a member of a class of drugs called protease inhibitors, which interfere with an essential process of viral reproduction.
While treatment with Crixivan was "generally well-tolerated," Merck officials said, patients taking it showed an increased incidence of kidney stones, diabetes, and sometimes fatal anemia and hepatitis.
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