TI   "Zidovudine in Asymptomatic HIV Infection"
 AU   Phillips, Andrew N. and Saben, Caroline A.
 SO   New England Journal of Medicine (12/16/93) Vol. 329, No. 25, P. 1895
 AB   Cooper et al. conclude that the benefits of zidovudine last more  
      than two-and-a-half years in asymptomatic HIV patients with CD4
      counts over 400.  Andrew Phillips and Caroline Saben of the Royal
      Free Hospital School of Medicine in London question the validity of
      Cooper et al.'s "on treatment" approach to analysis, in which data
      were censored three months after the end of blinded treatment.  This
      approach, say Phillips and Saben, should be supplemented with
      analyses in which follow-up information is not censored.  These
      analyses should consider the original primary end point for the
      trial--AIDS--as well as end points later adopted.  Cooper et al. do
      not even acknowledge whether AIDS developed by the end of the trial
      in approximately half of the subjects, 308 of whom withdrew, note
      Phillips and Saben.  The implied tendency of patients about to reach
      an end point to withdraw from the trial, they speculate, could
      actually have created a bias in favor of zidovudine.  Given the
      widespread belief that the drug's effects are limited, any suggestion
      that this time frame is longer should be supported with the
      demonstration of a statistically significant difference in risk
      between zidovudine and a placebo, considering the number of years at
      risk following two years of treatment.  The small number of patients
      with end points after longer than two years cast doubt, say Phillips
      and Saben, that such a difference was ever present. Therefore, they
      conclude, the suggestion that the beneficial effects of zidovudine
      last longer than two-and-a-half years is not justified based on the
      results presented.

      Copyright (c) 1993 - Information, Inc., Bethesda, MD.  This
      information is provided by the Centers for Disease Control &
      Prevention (CDC), National AIDS Clearinghouse as a public service. 
      Non-profit reproduction is encouraged.

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