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Is it time to start up again
Dec 23, 2001

Dear Dr Cohen:

Thanks for all your help. I wrote you several letters last year about taking an STI and your info was very helpful. I am now thinking about starting up again on medications.

I was on an Efaverenz/Combivir regime and took a break for a few reasons: I was going to be travelling and would find it hard to keep on schedule; also I was very worried about some side effects from Efaverenz (mantal vagueness). When I stopped meds CD4 was 600+, V/L was >40 (over 1 year).

I've had blood tests every 2 months. Ater the first my cd4 went down to 393, V/L up to 90,00. However, since then things have remained stable: last weeks results were V/L 93,000 and CD4 was 416. According to the lab where blood tests are done 405 is "normal."

My dr wants me to start up on meds, but I'm not so sure. Admittedly V/L is higher than I'd like but then CD4 are also much higherthan I'd anticipated. More importantly I'm feeling great: I've been exercising, eating well and feel better than when I was on the neds (the side effects were really an issue).

What do you think?

When I do start meds I do not want to go back to Efaverenz. DO ou have any ideas about a substitute? I was very happy with the clinical results but I prefer to be able to think clearly!

Thanks

Mark

Response from Dr. Cohen

Hey Mark. Glad the prior info was of help. Let's try again.

You describe the common outcome from med interruptions of this type - an initial drop in the CD4 counts - and return of the viral load. So now you are back in the dilemma that others are who have never taken antivirals at all - when to start/restart?

And, like with treatment interruptions in general, and treatment overall, there are no simple answers without controversy and disagreement. It is however fair to say that we have info to suggest that you could safely restart now, but you can safely defer if you prefer to do so, especially if you are feeling well.

Despite a "higher end" viral load (and anything above 100 thousand is often consider "higher"), we have examples of others who have done well off antivirals - deferring starting/restarting until some lower CD4 count. This line in the sand of when to restart differs among practioners - a CD4 count somewhere between now and a count closer to 250 is about where everyone is. Sounds like your clinician is more comfortable at the higher end. And there are good reasons for that decision. Since more virus usually just creates trouble in time...

But, sounds like you are simply not yet ready, nor convinced. And that is one of the key issues in helping know what the right time is - since if you are not ready, odds are good that you may not do the best you can at pill taking. And since you can wait, perhaps the key issue for now is a discussion with your clinician about what you want to use as triggers to restart. Like any early symptoms of not feeling right. Like some lower counts as well perhaps. The viral load is mainly a measure of how fast Cd4 counts will drop - but we can only generalize from our info - your response is ultimately something we can tell only by monitoring.

This issue is so central a discussion - how long to wait versus how soon to start/restart - that the NIH in the US has started a trial being done at 20 sites across the US and Australia to address this. The trial is called SMART, and the web site is www.smart-trial.org . One group will be assigned to start meds now - get that virus under control with the best feeling meds we can find... since who wants 90thousand copies of HIV floating around every milliliter of blood anyway? And this approach might include brief interruption of 7 or fewer days based on what we're learning about the time to viral rebound for those whose viral loads are <50 copies.

The other group will be assigned to wait. Like you are now. In the study, the triggers to restart are either a Cd4 count of 250 or less, or any symptoms suggesting you need to restart sooner. There are some other keys such as cd4 percent that can be used as well. But to wait - allowing you to have as much time off the meds as possible, delaying the use of meds, delaying the side effects from meds... until your body needed the help. And then when your cd4 count rose somewhere above 350 again - you could stop again. Minimizing time on meds, and hopefully staying as well for years to come - as you apparently feel now... with fewer total days on meds.

So no wonder we don't know what to recommend yet - this trial and others like it are only just beginning Jan 02... and it'll be a while before we expect to see a difference. Because for the past few years we know that people can stay on. And people can stop. And people can do well, and not so well, with either approach.

As for what to take when you do restart - you certainly can avoid efavirenz/sustiva if you need to. It is about the only med in the group that has the mental vagueness issues. What to use instead in part depends on other factors, like any other prior regimens before this one, and any other potential side effects that may limit or direct our choices one way or another...

Good luck. Hope that helps a bit.



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