TI    Partial Results of AZT Study Reported in Lancet
 AU    Food and Drug Administration
 SO    FDA Talk Paper
 TX    FDA is receiving inquiries about results of a European study of the
       clinical benefits of zidovudine (AZT) in people infected with the 
       human immunodeficiency virus (HIV) who have not yet developed symptoms 
       of AIDS. The partial results of the study, known as the Concorde 
       trial, have been reported in a letter published in the journal Lancet.

       The following may be used to respond to questions.

       The partial results reported in Lancet show no difference in clinical
       outcomes between people with asymptomatic HIV who received AZT early 
       in the course of the disease, and those treated initially with a 
       placebo followed by AZT treatment when AIDS symptoms appeared.  The 
       authors of the study also claim to have found no connection between 
       the increases in CD4 cell counts and the patients' condition after a 
       period of three years.

       It is important to note that studies have shown AZT provides clinical
       benefits to patients for 12 to 18 months.  For patients treated with 
       AZT for longer periods, the drug's benefits appear to decrease sub-
       stantially. 

       The study reported in Lancet does not call into question the clinical
       importance of AZT in treating symptomatic HIV disease or the relevance 
       of early CD4 cell count changes in predicting the short term benefits 
       of drugs like AZT.

       FDA believes this report clearly shows the need for continued studies 
       of AZT and other AIDS products to ensure that the usefulness of the 
       drugs is fully understood.  It will be important to explore what 
       factors, such as viral resistance, may be responsible for decreases in 
       benefits of the drugs over time.

       The Concorde study documents the need for trials that include clinical
       outcome data -- the effect of the drug on the course of the disease -- 
       and the need for postmarketing surveillance for drugs approved on the 
       basis of surrogate markers such as CD4 cell counts.

       FDA is looking forward to reviewing the data referred to in the Lancet
       letter, particularly those pertaining to use of surrogate markers to
       predict clinical outcomes.  Careful review and discussion with expert
       consultants will allow the agency to place the study in perspective and
       will indicate whether any changes in labeling for AZT are warranted.

 DE    AZT.  HIV infection.  Concorde trial.  Clinical trial results.  
       Efficacy.  Disease progression.
 CD    931005

 * Origin: AEGIS/San Juan Capistrano 714.248.2836 (CASAN)  (1:103/927)
 * Provided as a service of THE BACKROOM - NYC * 718-951-8256