Two new protease inhibitors approved by FDA. Food and Drug Administration. Clearinghouse, AIDS Newsletter Database, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5714.

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Two new protease inhibitors approved by FDA. Food and Drug Administration. Clearinghouse, AIDS Newsletter Database, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5714.

NIAID AIDS Agenda. 1996 Mar;:4-5. Unique Identifier : AIDSLINE AIDS/96701889
Folkers G

Abstract: The Food and Drug Administration (FDA) approved two new protease inhibitors--ritonavir and indinavir--for the treatment of HIV infection in adults. Ritonavir (Norvir), developed by Abbott Laboratories, received full approval for use alone or in combination with nucleoside analogue medications in patients with advanced HIV disease. Two encouraging studies on ritonavir are described. An ongoing phase III trial showed mortality to be 43 percent lower than for patients receiving standard therapy alone. In a separate study, untreated HIV-infected individuals who were given a triple combination of ritonavir plus AZT and ddC showed significant increases in CD4+ T cells counts and decreases in viral load for at least six months. Indinavir (Crixivan), developed by Merck, received accelerated approval for monotherapy and combination therapy for the treatment of HIV infection in adults when therapy is warranted. New data on indinavir showed decreases in levels of HIV in 22 out of 25 patients who had taken a triple combination of indinavir, AZT and 3TC. In another study of patients taking a combination of indinavir, ddI, and AZT, 60 percent of the patients' HIV levels were reduced to undetectable levels. In addition to ritonavir and indinavir, saquinavir (Invirase, Hoffmann-La Roche) is another protease inhibitor approved for use in conjunction with nucleoside analogues for the treatment of HIV infection.

Keywords: Drug Approval HIV Infections/*DRUG THERAPY HIV Protease Inhibitors/*THERAPEUTIC USE Human Pyridines/*THERAPEUTIC USE Thiazoles/*THERAPEUTIC USE United States United States Food and Drug Administration Valine/*THERAPEUTIC USE NEWSLETTER ARTICLE
961230
M96C1409

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