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  • Title: Delavirdine dilemma at the FDA. Food and Drug Administration.
    Author: Smart T.
    Journal: GMHC Treat Issues; 1996 Dec; 10(12):4-5. PubMed ID: 11364017.
    Abstract:
    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.
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