ANSWERS
06/27/1996

<TITLE>FDA APPROVES CIDOFOVIR FOR AIDS-RELATED RETINITIS</TITLE>
<PRE>






T96-46                                  Ivy Fleischer Kupec
June 27, 1996                           (301) 443-3285


FDA APPROVES CIDOFOVIR FOR AIDS-RELATED RETINITIS

     FDA has approved cidofovir (trade name Vistide), for
treating AIDS-associated retinitis.  The following can be used to
answer questions:
     Cidofovir was approved as an intravenous treatment for AIDS-
related CMV retinitis, a potentially severe eye infection that
can lead to blindness.
     Approval of cidofovir was based on two studies involving a
total of 148 patients.  One study showed that in patients treated
immediately with cidofovir, the disease progressed less rapidly
than in patients for whom therapy was delayed.  A second study
showed cidofovir to be effective in patients with relapsing CMV
retinitis who had received other CMV therapy previously.
     Cidofovir offers an alternative dosing regimen to other
therapies, which are administered daily.  Cidofovir is
administered once weekly for the first two weeks of treatment and
once every two weeks thereafter.
     Renal toxicity, the most significant side effect of
cidofovir, can be reduced by administering another drug,
probenecid, and by supplemental saline hydration on days when 
                             -More-            Page 2, T96-46, Cidofovir for AIDS-Related Retinitis
treatment is given.  Additional reported adverse events include
decreased white blood cells, weakness, nausea, diarrhea and
decreased intraocular pressure (low pressure within the eye).    
     Although concern has been raised by studies in rats that
have shown cidofovir to be carcinogenic, particularly in female
rats, cancers similar to those seen in rats have not been
observed in human clinical studies to date.
     Cidofovir is manufactured and marketed by Gilead Sciences
Inc. of Foster City, Calif. 
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