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Re: 5-on and 2-off
Jun 24, 2002

Dr. Cohen,

You had mentioned that the research group you are working with was investigating this type of regimen. However, the link which you provided only refers to a continous therapy vs. off-until-you-hit-250 therapy. This seems to be a different approach than what I was suggesting. Am I viewing the wrong protocal description? Also, why do suppose that you might not see resistance developing on 5-on and 2-off when a previous study saw resistance developing on the 2-on and 5-off regimen? Thanks.

Response from Dr. Cohen

Thanks for the update. The link doesn't list the trial I've mentioned since it is not yet up and running - it is in the final phases of review primarily by the FDA - and once it is cleared by them, assuming it is, it will go on the Web site. And the stop until 250 is a different trial issue, you are right. Check on again perhaps early July - or give a call if this is truly of interest to you since the FDA step usually takes no more than a month.

As for the lack of resistance to 5/2 - again, I hope we don't see it but that is where the research comes in. But the reason we believe it is safe to do the testing is that we don't expect HIV to rebound in the two days off - or at least if there is any rebound in HIV, that the 5 days on treatment will be sufficient to stop that process and prevent rebound. Since resistance only seems to occur when there is rebound. And we hope to prevent rebound with this design. However, the 2 on / 5 off design did not prevent rebound - HIV could grow back since with only 2 days on, and so there was not enough suppression from that amount of drug exposure. That allowed the 5-off to result in rebound. Again, there is no good way to predict what will happen in these various schedules - this is why we need to do the work in research. Certainly no one was expecting the 7off/7on to work as well as it has so far in the few patients taking that particular regimen - these other schedules need to undergo the same testing on similar and other med combinations before we can answer your question about what options there might be...

Hope that clarifies. Stay tuned.



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