Being Alive Newsletter, Being Alive/Los Angeles - July 1993
Mark Katz, MD and reported by Jim Stoecker

Arguments against early use include the prohibitive cost for those purchasing their own drugs and the possible disruption of the quality of life from antiviral side effects.

The big question that overrides all the pro and con arguments is whether early intervention really works. Does early use of antivirals prolong survival? There are three main studies that relate to this issue and each seems to have a different answer about when to begin using antivirals.

Results from ACTG019 were reported in 1989 and formed the basis for recommending AZT for those in the 200-500 T-cell range. This study tracked for over a year a large group on AZT and another group on a placebo. Researchers found a statistically significant slower progression to an AIDS diagnosis in the group on AZT.

In 1992, we had the results of the European Australian Collaborative Study. A group of about one thousand people with over 400 T-cells were followed for two years. Those on 1000 mg of AZT per day showed a statistically significant slowdown of progression to symptoms or a drop in T-cells to less than 350 or a diagnosis of AIDS.

Now we have the Concorde study which was presented and discussed in detail at this year's conference. The Concorde took place form 1988-91 and involved over 1700 study participants. All were asymptomatic at various T-cell levels. The participants were randomized into two tracks. The "immediate" group received 1000 mg of AZT a day while the "deferred" group only received AZT if they progressed to AIDS. (It should be noted that after the ACTG019 results were revealed, anyone in the "deferred" group with less than 500 T-cells could opt for AZT.)

The results of this study showed that, at any T-cell level, the use of AZT for asymptomatics did not change the rate of progression over a three year period. Whether the measure was development of symptoms, a diagnosis of AIDS, or death, the outcome was the same for both the "immediate" and the "deferred" groups.

It should be noted that, at one year, the treated group was doing better than the untreated group. This supports the notion that AZT may have limited efficacy. Researchers also reported that T-cell count was higher and stayed higher for those on AZT. But the results of the study lead one to question whether T-cell count is really a valuable surrogate marker.

Over the three years of the study, only about 8% of the participants progressed to symptoms. This shows that for people without symptoms, HIV progression appears to be slow. Lack of symptoms may itself be a major cofactor.

So what can one conclude from all this? Is early intervention with antivirals the way to go? If you go with the European Australian study, the answer is yes. If you use the Concorde data, the answer is "not really." And if you look at the ACTG study, you see that we don't know enough yet. ACTG has further studies underway to determine if there is a survival benefit to early antiviral use.
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