AZT: FDA COMMITTEE RECOMMENDS EARLY USE

On January 30, an advisory committee of the FDA unanimously recommended that AZT be officially approved for treating persons with T-helper counts of 500 or less, even if they have few or no symptoms. Approval is not yet official, but the agency almost always follows such recommendations of its advisory committees.

Physicians already can legally prescribe AZT for any patient, without specific FDA approval. But more physicians will prescribe it for early HIV infection when the drug's official "labeling" suggests that they do so. And when the new recommendation becomes official, it will be much easier than now to get insurance companies to pay for AZT for those patients. Hundreds of thousands of patients could be affected by the new recommendation -- but probably most of them do not know that they are HIV positive and will not be receiving medical care.

In the past, the main arguments against early AZT use have been fear of side effects, and fear that the virus might become resistant to the drug. But now it is clear that side effects are much less of a problem if patients are healthier when they start AZT -- especially with the lower doses which are increasingly being used. There seems to be less concern about early use causing viral resistance, and more thinking that the drug might be even more effective at slowing the development of the disease if given early than if given late.

Much is still unknown about long-term effects of AZT. The advisory panel decided that it was better to take the risks of using it earlier in HIV infection, than to take the risks of leaving the infection untreated.