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Will the 5d on/2 d off work in my case?
Jul 20, 2002

Dear Dr. Cohen, Thanks so much for your untiring effort to answer our questions. I'd like to get your opinion for my case. I'm currently on Epivir, Viread and Sustiva (diagnosed positive over a year ago). My VL has been undetectable (<50 copies/ml) for a year now, and CD4s at 473 from a nadir of 393. Previously on Epivir, Zerit and Norvir-Fortovase but my doc took me off the PI and Zerit after I developed lipoatrophy. I'm still slowly losing the fat in the face and extremities. I also so desperately want to get a break from the daily meds. I'd like to try the 5 day on/2 day off cycle (plan to work on this with my current doc). Will this work for my current regimen? Should I withold Sustiva the day before my last dosing? Your opinion will be greatly appreciated.

Response from Dr. Cohen

If only we knew, I'd tell you. But we don't... yet.

As we've discussed here recently, studies of interruptions are still early on. And studies of brief interruptions are few in number. So far the only info we have to guide us is the ongoing successful control of HIV in a study where now a total of 18 people who started with a viral load <50 on a regimen change the schedule, taking meds instead for one week, and then stopping a week, then restarting a week, and back and forth they go. A year later, those taking a PI based regimen show ongoing control. And in recently presented data, those on Sustiva/Videx/Epivir are also maintaining control as well. One lesson we are learning is that interrptions of fewer than 7 days does not appear to lead to rebound in these studies, and that is one reason they're successful. And whatever is happening under the surface in that week off is balanced by the control that is reestablished with one week back on. Now, in the studies that don't allow rebound, such as this one, all the meds are stopped at the same time - since the need to stagger the interruption to avoid resistance is based on trying to avoid drug levels during the regrowth of HIV. But if the interruption is brief, and if HIV rebound does not occur, then all meds can be stopped at the same time. At least that has been the approach by the NIH group led by Dr Mark Dybul. And it has worked. However, it is fair to point out that a European trial did see rebounds of HIV in those stopping a regimen in as few as 4 days off... so we are still learning.

Now what is still unknown is whether stopping for 2 days and treating for 5 days will be similarly successful at maintaining control. We just don't know since these studies are just getting underway. For example, in Boston we are just getting started - expecting to begin in August 02 with this type of research -- and those interested in this type of research can get in touch with us by clicking here.

What is not known is if 5 days on can maintain control given the interruption of just 2 days. Without that info it is hard to know if this schedule would work, although our research study should have answers pretty soon. Even if there is ongoing suppression what is even less known is whether any interruption will allow a reversal in some of the body shape changes we see. There is some optimism in that some have reported reversals with some of the drug substitutions -- whether brief interruptions will work for this is brand new and uncharted waters. So we'll be monitoring this issue to guide this...

Much to learn. For now whatever you do, I'd do it with lotsa monitoring to catch any surprises quickly before damage is done. Knowing that the risk of going first is to be the one to teach others the errors we might be making... while noting that the benefit of going first is to get the benefits first and be able to share it with others...

Good luck.



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