AZT ASYMPTOMATIC STUDY PUBLISHED -- NEW PUSH FOR EARLY DIAGNOSIS, TREATMENT

Results of the major U. S. trial of AZT for early intervention in asymptomatic HIV-positive patients (ACTG 019) were published April 5 in the New England Journal of Medicine. The major findings were already known, but physicians have needed more details to guide them in deciding when to recommend AZT.

ACTG 019 compared daily doses of 500 mg, 1500 mg, and placebo. AZT clearly reduced progression to AIDS, as well as showing benefit in other measurements, such as T-helper cell increases and p24 antigen reductions. The 500 mg dose not only had lower toxicity than 1500 mg, but also the low dose may have been more effective. For example, the rates of progression to AIDS per 100 person-years were 6.6 with placebo, 2.3 with 500 mg (low dose) of AZT, and 3.1 with 1500 mg.

Toxicity not only was less with the lower dose, it was also less for asymptomatic patients than for those more seriously ill. When used in low doses for early treatment, AZT seems not to deserve the reputation for toxicity which it had in the past. For example, there was no statistically significant difference in hematologic toxicity (anemia or neutropenia) or in elevated liver enzymes between the placebo and 500 mg group; nausea (reported by 3.3 percent of the low-dose group vs 0.2 percent on placebo) was the only severe side effect significantly more common with the low dose than with the placebo. (Anemia was found in 1.1 percent of the low-dose group, but was not severe enough in any patient to require a transfusion.)

This study re-emphasized the need for people to learn their HIV status and start treatment early. The message is getting out. On March 28 about 300 people had to be turned away from a San Francisco talk by Paul Volberding, M. D., the principal investigator of ACTG 019, on new information about AZT, due to unexpected turnout. The presentation will be repeated in a larger hall on Friday, April 13, at the UCSF Laurel Heights Auditorium, California St. at Presidio, 7:00 - 9:00 PM.

These AZT results also highlight the problems of getting treatment to those who cannot afford the price of AZT (currently about $2,200 per year to wholesalers at the 500 mg dose). And even if money is available, many persons with HIV have never had access to primary care; they seek medical treatment in hospital emergency rooms, only when they are very sick. An editorial in the April 5 New England Journal of Medicine ("Early Treatment for HIV: The Time Has Come") commented that "For these persons, the health care needed to provide the demonstrated benefit of early therapy is simply not available. Thus this major advance will result in a cruel and painful irony, and it highlights the urgent need to marshal resources and implement systems of care for all people with HIV infection."