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  • Title: Delavirdine data: skewed or skewered?
    Author: Mascolini M.
    Journal: J Int Assoc Physicians AIDS Care; 1997 Feb; 3(2):42-6. PubMed ID: 11364099.
    Abstract:
    Results of clinical trials using delavirdine, a reverse transcriptase inhibitor, were met with mixed reactions from the FDA Antiviral Drugs Advisory Committee. Half of the committee voting on accelerated approval were not convinced that viral and CD4 results would provide a clinical benefit. Three trials combining delavirdine with AZT and ddI were conducted. Two of these trials showed reasonable increases in CD4 count; the other showed a mild increase in CD4 count, but with an increased number of deaths in the group receiving delavirdine vs. placebo. The committee used an in-depth analysis of these trials to point out confusing issues brought up by the mixed results of the trials. Controversy remains about the longer-term significance of the CD4 and viral load values. Other issues surrounding the use of delavirdine involve adverse effects, development of viral resistance, and interactions with a variety of drugs. In contrast to delavirdine, nevirapine, another reverse transcriptase inhibitor, sailed through approval with no problems, allowing observers to compare the two approval processes.
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