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drug holiday
Aug 19, 2001

Dear Doctor, I started a drug holiday on may23 when I dropped sustiva,and May 29 when I dropped epivir/abv On 5/14 cd4 935/36% vl<50. I retested on 6/20 bec i wanted to do a geno and cd4 was 801/35% and vl<50, then 6/29 cd4 968/39% and vl<50. (I retested bec I wanted to get a genotype done) Then 7/13 cd4 796,34,vl=259 (I didn't do a genotype). Can you spot any trends based on these lab values? Any new data from Buenos Aires that might shed light on drug holidays? I plan to restart when cd4<500 or 25% or vl>50,000 or some combo of these values. Would you still recommend adding a pi for the first week before sustiva gets up to proper levels ? Sincerely

Response from Dr. Cohen

Sounds like your treatment interruption is showing some underlying immune competence here.

One of the largest studies done in those with chronic HIV infection (as opposed to studies done in acute infection, soon after exposure) - has been updated several times. This is the Swiss Spanish Intermittent Therapy Trial, or the SSITT. (For obvious reasons, the Hungarians couldn't participate in this one...). What they have showed us is that there are those with HIV infection who, after stopping take a while to have a rebound in their viral load. About 15% or so take longer than two weeks for the viral load to go back to detectable from <50. In your case it seems to have taken about a month or so.

Why this is of interest is that they have found that this group seems, in their study of repeated interruptions, to have the best chance of lowering the viral load "set point" off of medication one year later. Meaning that if before meds your viral load was up to 50 thousand, after a year of repeated interruptions and restarts, for those like yourself with a slow rebound, there was a 50% chance that your viral load might be <5000 copies off meds. For those who did rebound before two weeks, there was a lower chance (about 15%) that the set point would decline to <5000 off meds.

So that is the good news we have. The other news is about the short cycle off and on meds - and in these studies people are stopping just for the goal of having less total days on meds, to have less total drug toxicity from meds. Here the data were also relevant to you in that those who did stop, even for as little as a week, started to see normalization of at least one side effect - the increases in cholesterol that are seen on at least some of our meds.

Now no one in these studies in general are on the nonnuke - there is ongoing concern about how to stop a regimen containing one. Indeed, in one study for those on nevirapine/viramune, there was a fairly high rate of seeing resistance to this medication class after interrupting a regimen with this drug. Your approach - of stopping one week before, is one of several that are done to minimize this risk - but there are as yet no guidelines as to the best ways to do this.

However when you do restart - it is likely to be just like starting a regimen the first time - if you start on a combo like epivir, abacavir, and sustiva, it works well. And that should be the case whether you are on it the first time, or on it after stopping it in the past. If there is no resistance from stopping, it should work just as well. And no PI is needed to assist in the first week on. A PI is sometimes used by some clinicians in the week you are stopping Sustiva however - so instead of being on just epivir/abacavir, some would add a third drug like a PI, and then stop all three. This is done so as to not risk rebound in that week on just two meds. But given you specific observation of being <50 for even a month, this additional medication is probably less important. Nonetheless, as 3TC is considered one of the more "fragile" meds to which HIV can readily create resistance, some would use a third drug no matter what.

Finally, when to restart. You listed your own criteria which are certainly reasonable. However, the US NIH has just funded a study, in part guided by the US and European, Canadian and Australian guideliness, all of which agree that it is reasonable to delay starts until your CD4 count is nearer to 200. And so as a result, a study scheduled to start Oct 2001, called the SMART trial, will randomize people to either stay on meds to maintain suppression, with at most brief interruptions, or stop meds and restart only if the CD4 count is about 250 -- stopping again when somewhere above 350. Another way to do it. Your way is fine as well - we lack info to guide us, and thus the trial is starting, to give us some of the needed guidance.

Hope that helps.



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