FDA APPROVES, NIH RECOMMENDS AZT FOR ASYMPTOMATICS

On March 2 the U. S. Food and Drug Administration (FDA) formally approved a change in the labeling of AZT, expanding the indications for use of the drug to include all adults with HIV and a T-helper count of 500 or less. For asymptomatic individuals, the dose recommended was 500 mg per day (100 mg every four hours while awake). For those with symptoms, the recommended dose was higher, the same as for persons with AIDS -- 1200 mg per day for one month, which may then be reduced to 600 mg per day.

Then, during the next two days, a panel of 19 clinical researchers, community physicians, and others met at a conference organized by the U. S. National Institute of Allergy and Infectious Diseases (NIAID) to prepare recommendations for early use of AZT. This panel made similar, though not identical, suggestions, recommending 500 mg per day for both asymptomatic and symptomatic individuals. The executive summary from that conference also includes recommendations on how often to check T-cell counts for different groups of patients, and on how to manage persons on AZT.

Both of these government actions have been expected, and the recommendations are not surprising. A number of physicians, especially in cities such as San Francisco, have already been providing early AZT treatment to private patients. The importance of the FDA and NIAID actions is that it should now be much easier to get government and private third-party payors to cover early use of AZT, making early intervention available to many who otherwise could not obtain it.

About 600,000 people might benefit from early HIV treatment in the United States alone. Many of them, however, do not even know that they are infected.