A study released today by the Department of Veterans Affairs casts doubt on the effectiveness of the primary drug used to treat AIDS - azidothymidine, or AZT.
In the longest AZT study ever conducted, VA doctors found that AZT slowed the development of AIDS. But the group also found that a patient's likelihood of living longer did not improve when the drug treatment began early.
The Food and Drug Administration recommends people infected with HIV routinely take AZT as soon as their crucial immune defense cells - called CD4 cells - drop to a blood count level of 500. When people have CD4 counts above 500 they generally feel fine most of the time and do not yet have AIDS. Some physicians put people on AZT when they have CD4 counts of 800.
The VA study of 338 HIV-positive veterans found it made no difference, in terms of survival, whether a man started AZT when his CD4 count was 200, 300 or 500 - the individuals died in the same amount of time. Taking AZT early, when CD4 counts are high, does delay the onset of full AIDS in white men, but not the overall time between diagnosis and death.
For blacks and Hispanics, early use of AZT seemed to make matters worse. More blacks and Hispanics died over the course of the 2 1/2-year study in the early-AZT group compared with those who waited to take AZT until their CD4 counts fell below 200.
"If one wants to take AZT early, I think that's still a reasonable choice," VA study director Dr. John Hamilton said in an interview. "But I think one needs to know what one is getting for it, and losing."
Early AZT-users in the VA study suffered more anemia, leukopenia blood disorders, nausea, vomiting and diarrhea. Early AZT users went longer with such side effects, but also delayed the onset of full AIDS. Once they developed AIDS, they died more rapidly than late AZT users; the net effect was that about 13 percent of the men in both groups, after 2 1/2 years, have died.
"I think it's human nature to want to have something you can do, whether you're the patient or the doctor," Hamilton said, noting that AZT is the only relatively well tested drug available for AIDS treatment. "So it's not surprising people would give the benefit of the doubt to the activity of agents in such a grim situation. But I believe a dash of skepticism is healthy."
In a prepared statement Burroughs Wellcome Co. which manufactures AZT, questioned the design of the study, which is similar in some aspects to those in past studies that were more favorable to the drug. The company also urged people not delay taking AZT until their CD4 counts fall below 200.
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