Protease inhibitors and beyond: interview with David Feigal, M.D. [interview by John S James] Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Protease inhibitors and beyond: interview with David Feigal, M.D. [interview by John S James] Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

AIDS Treat News. 1995 Mar 24;(no 219):1-6. Unique Identifier : AIDSLINE AIDS/95700356
Feigal D

Abstract: Dr. David Feigal, M.D., Director of the Division of Antiviral Drug Products of the U.S. Food and Drug Administration (FDA), agrees that protease inhibitors are the most promising single approach to HIV treatment today. There are, however, several obstacles to the development of these experimental drugs. The compounds are difficult to produce, often requiring multi-step synthesis processes, and there are additional problems with trying to scale-up to large quantities. The supply problem makes it difficult to decide how to provide the product to people who cannot participate in clinical trials. The lottery method, used with Betaseron for multiple sclerosis, was unpopular. Dr. Feigal suggests a partnership between the community and the companies to devise a distribution strategy. In addition, there are other treatment options showing preliminary data results in the same general magnitude as the protease inhibitors. Dr. Feigal also mentions that a workshop on AIDS clinical trials will be organized for late spring or early summer.

Keywords: Clinical Trials CD4 Lymphocyte Count Drug Approval Drug Industry Health Services Accessibility HIV Infections/BLOOD/DRUG THERAPY HIV Protease Inhibitors/ADVERSE EFFECTS/SUPPLY & DISTRIBUTION/ *THERAPEUTIC USE RNA, Viral/BLOOD United States United States Food and Drug Administration Viremia NEWSLETTER ARTICLE INTERVIEW

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