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On Again, Off Again
Oct 17, 2001

Hey Doctor Cohen. Long time no correspondence. I'm doing well so no need. :) I do have a question for you since you are the all knowing brainiac. Have you heard about the One Week On / One Week Off meds trial being done at NIAID by Tony Faucci? I think it's been about a year that he's been doing this and I'm wondering if any results have been published. If it's effective and does not lead to resistance, it would be phenominal for patients. It could reduce side effects and cut the cost of treatment in half and hey, I'm all about getting the bargain. :) Let me know if you know of any published results. By the way my personal updat is Undetectable below 50 and a CD-4 of 1255 and 28 Need to work on my percentage, any suggestions? I'm on Trizivir and Remune (Remune for three years now). Considering I started with a VL of 2.2 Million and a CD-4 of 153 and 13 in May of 97, I can't complain and you'ved helped me all along the way. Hope my recovery encourages others. As always, thanks for you help and letting me pick your brain.

Atlanta

Response from Dr. Cohen

Hey Atlanta - it has been a while. And great news on the numbers you've got. I, on behalf of the few hundred thousand monthly readers, have been wondering...

So - yes, I am aware of the 7/7 trial that the NIH group is doing. This is a study designed and run by Dr Dybul, in the group led by Dr Fauci. What they did is to take advantage of information from other studies where people were on antivirals, and had a viral load below 50 copies, and then stopped meds. This was done to see how long it would take to rebound and other issues related to work they were doing on IL2. They noted that it seemed to take at least 7 days before the viral load would go above 50 copies. Now, there are a few reasons that treatment interruption is of interest - one is to intentionally reexpose HIV to the immune system - to act as a vaccine. This approach may be helpful for some, as perhaps 15-20% seem to respond in a way that may decrease the off treatment viral load "set point". For them the interruption needs to be more than 7 days.

However, since this was only helpful for some, they focussed on a second issue. If there are some with drug side effects that are related to being on meds every day, then periods of time off might decrease these side effects. And so they did a study where they stop for only 7 days to maintain the viral load below 50 copies while giving the body this brief rest off meds. So what are the results so far?

Well, the study is a small pilot of ten people - as it must be, when going somewhere new. Thus, the results seen may not generalize to everyone who is interested in doing this. So far, not everyone maintains a viral load <50 at day 7 off meds. There are some with detectable viral loads. However, in the 7 days back on, the viral load does resuppress. And so far there is no resistance developing to the meds. So, from that perspective, it is "working" to maintain viral control.

As for side effects, the cholesterol increase that some have from the protease inhibitor they are on (the regimen is d4T, 3TC, low dose ritonavir, and indinavir) does tend back towards normal after a week. Whether other side effects are fewer - including lipodystrophy and blood sugar problems - we don't yet know. We don't know if 7 days off is enough to prevent whatever the longer term drug related side effects are overall, since it is still unclear what causes them all.

And do people know which week it is? Will people remember that this is the on week, that I restart today, and so on? The adherence concerns have been raised, and it is likely this approach will not be attractive to all.

But your results are striking - and consistent with what others have seen, which is ongoing suppression, and with it, the regrowth of t4 cells that we say with those on meds daily. Whether Remune deserves any of the credit is hard to say... as studies of this agent continue to be just shy of conclusive... As for your t4 percent, all we can say is that you are fine, and I wouldn't fret about that value given the counts you have. Viral suppression allows the body to do what it can to repair -- and your counts and percent are both in a very protective range.

These results are now leading to more studies of this approach. For example, this approach has been incorporated into a mega study, now being launched by the NIH CPCRA group, comparing viral suppression - whether on meds every day or with brief interruptions such as this - to another strategy where people stop meds when the CD4 count is above 350, and restart when closer to 250, cycling on meds for what may be an ever shorter number of days. As it is unclear if brief stops truly minimizes all of the drug toxicity - or perhaps longer interruptions are more helpful in minimizing the cumulative drug toxicities - restarting meds only when the immune system needs the "help". This study will see which overall is a more successful strategy in maintaining health and minimizing any drug side effects... So stay tuned.

As for being considered "brainiac", I though myself more like Batman than him... but thanks...



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