Health Education AIDS Liaison, Toronto


Risk of Progression to AIDS and Death in Women Infected With HIV-1 Initiating Highly Active Antiretroviral Treatment at Different Stages of Disease [pdf file]
Anastos K, Barron Y, Miotti P, Weiser B, Young M, Hessol N, Greenblatt RM, Cohen M, Augenbraun M, Levine A, Munoz A
Arch Intern Med 162: 1973-80 (2002)

COMMENTARY

The paper is torture to read because of the confused logic and techno-babble, but it provides otherwise hard-to-come-by useful data on just how ineffective HAART really is. As usual, the authors do not provide a control of consisting of the outcomes of women who were HIV-negative or the outcomes of HIV-positive women who did not take HAART. Nevertheless, the results are highly damaging to the value of HAART.

Here is an example of techno-babble at its finest, however, it still contains the seeds of truth that HAART has no health benefits. "Simple and direct comparisons of survival after HAART is initiated at different stages of disease do not suffice to allow conclusions regarding when to start: those who initiate treatment at a later stage had an unmeasured survival benefit before HAART was started. This lead time survival needs to be considered in analysis of data from cohort studies."

I think the simplest translation is that, "Simple and direct comparisons of survival after HAART" show no benefit of HAART. This is confirmed by the astounding admission that, "those who initiate treatment at a later stage had an unmeasured survival benefit before HAART was started". Perhaps if HAART was never started the "unmeasured survival benefit" would continue.

The study examined giving HAART to women who were AIDS-free at initiation of HAART compared to giving HAART to women who had AIDS at initiation of HAART. The primary outcomes were "development of a clinical AIDS-defining event and death". About 25% of AIDS-free women were admitted IV drug users, whereas the figure was 36% for the women who already had AIDS at the start. And 84% of both AIDS-free women and women with AIDS at start had a history of anti-HIV drug-use other than HAART. So, almost all women had a history of drug use before entering the study when HAART was added to their drug-burden.

"Of the 25 deaths in women with AIDS at HAART initiation, 14 (56%) were unrelated to AIDS and 19 (76%) occurred in women who had not reported an AIDS-defining event before death." Over half of those women died of something other than AIDS. I suggest that the something else was recreational and anti-HIV drug-use.

"A history of no exposure to antiretroviral treatment before HAART was not significantly associated with death in women who were AIDS free (RH [relative hazard], 0.78; 95%CI [confidence interval] 0.23-2.61) or who had AIDS (RH, 1.01; 95% CI, 0.53-1.91) at HAART initiation." That was the pessimistic way of looking at it. Another way to look at the results is that lack of antiretroviral treatment did not cause women to get sick and die. According the mainstream wisdom that should not be the case. But in fact, the AIDS-free women at start who never used anti-HIV drugs before the study lived longer than the women who had taken other anti-HIV drugs before entering the study. That's what RH, 0.78, signifies. An RH>1 means greater likelihood of death and RH<1 means less.

Now for the conclusion. "[D]elay of treatment until CD4+ cell count falls below 350/mL appears to have clinical benefit at least equal to that conferred by earlier initiation of therapy. On the other hand, women who initiated HAART with CD4+ cell counts less than 200/mL had significantly more rapid progression. ...Thus, therapy may be deferred until CD4+ cell count reaches 350/mL, but the optimal point at which to start therapy with the CD4+ cell count category between 200 and 350/mL remains to be defined."

In other words, there is no life-saving advantage to initiating HAART early, i.e., at CD4+ cell counts above 350/mL. And importantly, HAART actually accelerates progression to AIDS and death if initiated late, i.e., at CD4+ cell counts less than 200/mL. The authors hold out the hope that if HAART has any benefits at all, it is in a very narrow window of administration somewhere between 200 and 350 CD4+ cells/mL.

David Rasnick PhD



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