Delavirdine dilemma at the FDA. Food and Drug Administration
Smart, T.
Gmhc Treatment Issues the Gay Men's Health Crisis Newsletter of Experimental Aids Therapies 10(12): 4-5
1996
ISSN/ISBN: 1077-1824 PMID: 11364017 Document Number: 464101
For the first time, the Food and Drug Administration (FDA) Antiviral Advisory Committee has not been able to recommend approval of the anti-HIV drug delavirdine. The trials used as background evidence showed no significant difference between combinations with and without delavirdine, and no less disease progression was seen. In addition, the possible interaction of delavirdine with protease inhibitors could cause drug levels to raise to dangerous levels. Data on the use of this drug in the pediatric population was also absent. More specific results of the delavirdine trials are provided.