Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
AIDS task force grapples with faster access to protease drugs. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.
J Int Assoc Physicians AIDS Care. 1995 Mar;1(2):6-11. Unique Identifier : AIDSLINE AIDS/95700332 Mascolini M
Abstract:
Three key questions were addressed at the February 23-24 meeting of the National Task Force on AIDS Drugs Development: 1) what can be done to accelerate approval of the protease inhibitors, 2) can enough drug be obtained from the manufacturing process to permit expanded access programs without limiting the supply needed for phase III clinical trials, and 3) how can trials be structured to verify that positive effects on viral load (if demonstrated) will result in a measurable delay in clinical progression? While several AIDS organizations signed a consensus statement urging Abbott, Merck, and Hoffmann-La Roche to file for accelerated approval of their protease inhibitors by the second quarter of 1995, the companies are unlikely to meet that goal. However, Roche and Merck do confirm accelerated plans using U.S.-Canadian and European trials for data. Supply has largely been a problem of production lead times, but improved techniques are beginning to cut production time, as evidenced by the reduction of Roche's saquinavir production by eight months. Other manufacturers are not as aggressive in their approaches to supply. David Kessler, commissioner of the Food and Drug Administration (FDA), promised to pursue the accelerated processes to gain more access to these drugs. Meeting participants offered no easy solution on how to plan trials that will confirm clinical benefit after a drug wins accelerated approval; all agreed, however, that phase III trials or postapproval studies must be mounted to demonstrate a drug's effectiveness following approval.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY CD4 Lymphocyte Count Drug Approval *Drug Design Human *HIV Protease Inhibitors/CHEMICAL SYNTHESIS/THERAPEUTIC USE Pyridines/THERAPEUTIC USE Treatment Outcome United States United States Food and Drug Administration Zalcitabine/ANALOGS & DERIVATIVES/THERAPEUTIC USE Zidovudine/THERAPEUTIC USE NEWSLETTER ARTICLE
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Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
