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About SMART
Jan 21, 2002

I have just read new trial (www.smart-trial.org) on treatment strategies starting in U.S. and Australia. It seems they are going to study patients over 7 years with two treatment strategies: a/treating and maintaining treatment when cd4 fall to 350, and b/ start treatment when they fall to 250 cd4 and interrupting when they reach over 350 again. And my question is: Do you really think the second option will work?. I am not a doctor, just positive 17 years ...but just a 100 cd4 difference does not seem like an awful lot, and you know one can lose them practically in a couple of weeks ... which would point to nearly interrupting treatment every month or so .. Is that the aim? Does it not make more sense to let them go up further and stay off longer? Thank you for your always appreciated point of view.

Response from Dr. Cohen

Well, first, thanks for your appreciation.

So can we cycle these meds on and off and on again? Will that help? And will the time off be long enough to matter given the counts you note are in the study?

There are actually a few different studies that have shown what can happen when people stop meds. And what is clear is that there are variable outcomes of what happens next. For some the viral load will zoom back up in a few weeks, the counts will fall again, and someone would be back on meds in a month. And it is then at least a few months back on before the counts may be high enough to "re-stop". And that type of off/on schedule may or may not be of any use in doing what this arm of this study is aiming for - maintaining someone free of the complications of HIV while maximizing time off meds.

But the other possible outcome observed when some stop meds - is that the counts are stable for months and months. Over a year for some. And the viral load may come back slowly, at some variable rate. But for some, the expected return of HIV is not associated with a rapid fall in the counts. One predictor of who is best able to handle this time off -- with the longer time off meds before needing a restart -- is the history of how low the counts ever were in the past. Those with a history of very low counts seem to have a higher risk of having the CD4 counts drop more suddently when stopping meds. But, for someone who started treatment with, say a CD4 count of 300, and now has counts over 500 -it may be months or even years before the counts would be near 250 - the restart trigger in this study. And once back on meds, and over 350- it may take many months off again before getting to 250 - so that is where these counts came from - these types of reports. One study, for example, reported an average of 16 cells lost per month off - and at that average rate, someone might have six months off if stopping at 350, and waiting until 250.

The protocol does have room for judgement after the first interruption - for example, it allows the clinician to use the experience of what happened the first time off meds to guide what to do when the counts rise back on meds. If, as you say, someone just over 350 dropped to below 250 in a few weeks off - there is the opportunity to delay the next stop until some higher count the next time. This was among the features built into this very long term study in an attempt to ensure it was able to meet the needs of the thousands who are needed to answer the question of how to use our treatments. But these triggers may, for some, allow say, six months on, and six months off - and if so, this may lead to some interesting findings.

Since how to treat remains a subject of ongoing discussion and debate - based on our success when we do treat. Do we just keep HIV under control once it is there, keep those counts up on meds, while risking the complications of meds? Or do we try to avoid these complications by using the meds for as few days as possible, interrupting when the counts are "good enough", and restarting before the risk of HIV related illnesses is a concern?

Will the study work? You ask an important question and one that will be monitored by the study team to ensure that this strategy is worth doing for years and years.... but based on what other studies have reported, yes - there are some who can and do stop and it is months before they need to start. And for them, this time off can be another way to get to the goal of a long and healthier life.

We shall see. Thx for the observation.



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