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What happened to SMART?
Jan 29, 2006

Dear Dr. Pierone,

From previous posts, I understand that you are, or rather were, involved in the SMART Study. I recently read that SMART was being discontinued due to poor epidemiological outcomes. Do you concur with this? Or, could this be big pharma's way of keeping people on drugs in their effort to keep their shareholders happy? In one post you reported that both arms of the trail were doing equally well. So, in the end, who can we really trust?

Response from Dr. Pierone

Hello and thanks for posting.

I am involved in the SMART study and our team has about 70 patients enrolled in the trial. The study is closed to new enrollment but worldwide there are over 5000 patients already in, and the study is ongoing. However, the subjects on the treatment interruption arm are being informed of the better outcomes in the other group and being offered HAART.

This does not mean that everyone on the treatment interruption arm will restart therapy. Some of the patients in this trial have low viral loads and high CD4 counts and will choose to defer therapy.

About 3% of subjects had AIDS progression events or death in the treatment interruption group versus about 1.5% in the continuous treatment group. In a previous post I mentioned that in our (70 patient) experience we saw no differences, both groups were doing well. But this highlights the fact that very large studies are needed when there are small differences in outcomes between two strategies.

Big pharma would never even consider sponsoring a trial like this (although they might be interested to see if 4 or 5 drugs work better than three). This study was funded by the NIH through the CPCRA.

So is treatment interruption dead? I don't think so. A European study called BASTA looked at the same notion of CD4 count driven treatment interruption, but started patients on therapy at a higher (and perhaps safer) CD4 count level and also interrupted therapy at a higher threshold. Maybe we should be initiating HIV therapy before the CD4 count drops to less than 350, but maybe we don't need to keep people on treatment continuously. These questions are still very much unanswered.

Finally, there are so much data from SMART that it will take a while for it to be analyzed. This analysis may provide some ideas for future study. Stay tuned!



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