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when to restart?
Apr 27, 2003

Dear doc,

23 months ago (June 2001) I stopped therapy to take a break. MY vl was <50 and my CD4 was 935 and 36. While on therapy I was always <50 and lowest cd4 ever was 600 and 32%.)

When I stopped therapy my restart values were if cd4 goes below 500,if cd4% drops below 25 and if vl goes above 50,000.

Lately I've read that a high vl is trouble regardless of how high the cd4 count is, so I'm not sure I should wait until my vl goes above 100,000 before I restart. You can see the trend here:

I tested my vl monthly off meds and here are the data. Month 1,<50,then <50 then 259, 5790, 2990, 5300, 3470, 5770, 5540, 9590, 3670, 8740, 4340, 5310.

At month 18 off meds

11/02 cd4 785 and 29% vl l8650. 1/03 cd4 638, 33% VL 8100. 3/03: cd4 643 /31% 12,400. Then 4/03 cd4 610 / 30%, VL 21,100.

You can see in the last few months my vl has been increasing and my thought is that it will prob continue to increase. (My highest vl before I started therapy was 40,592)

Any thoughts, Sincerely, Luke

Response from Dr. Cohen

Thanks for the details data and even a flow chart of numbers. Perhaps you're an accountant? The details help answer your question.

In general when people stop meds - the viral load goes back to about the level you had before you started treatment. So initially you had a partial improvement (decrease) in that set point - one of the more exciting observations about Treatment Interruption research that led to all this interest in it - since it we could keep your viral load lower, say 5 thousand while off meds - you might have a stable Cd4 count and stay healthy as far as we can tell - for years - without needing antivirals. Over time the Cd4 counts off meds will usually fall - but how fast they fall can vary which is why we recheck them over time...

And in your case that was what happened - for a while. It is not clear why this happens - but it does for some people. Now at year two your viral load is still below your highest ever - but heading up as you note. However - since your highest ever VL before treatment was only about 40 thousand, it is unlikely that it will go above this value while off meds. It can happen sadly - there are some in whom, over time, the immune system loses the ability to maintain the original set point and it can go higher for some - but more typical is that it will go back to this set point and stay there for some time... and so if your time to restart was 50 thousand - you may not get there for a while and if your restart number is 100 thousand - it may never happen.

So in general - the risk of stopping is that the Cd4 counts drop - and usually the lowest they initially drop to is the lowest they ever were - and again, since you had good counts before you went on meds - you are staying up at this same safe level off of them.

But your question is in part when should you restart meds. And you mention you had some numbers in viral load and Cd4 counts/percents as triggers for your decisions. And you also mentioned some concern about viral load itself - as a restart trigger. Here's what we're learning still.

In general many people don't have symptoms just from their viral load - that explains why in part we have the epidemic of HIV that we have - since many people have ongoing viral growth, and as long as the Cd4 counts were above 200 - people felt well and had no illnesses or symptoms that were due to HIV infection. Above 200 cells we might see some early symptoms - things mainly that show up on the skin or mouth. But others had no warning until lower counts and then had something like pneumonia. Which is in fact why we talked about routine screeing for people at risk - since we could not rely on symptoms to focus our screening efforts and prevent these pneumonias and other complications.

Now - this means that viral load itself doesn't usually cause symptoms. You mention reading something about the risks of a high viral load causing trouble - and it is fair to say that the higher it is the more reasons we have to at least worry about it. But with current treatment and the improvements we have in improving the potency of treatment - we have confidence that even at high viral loads we can control HIV. And so that's led to more controversy as to whether someone with high CD4 counts but a high viral load "needs" treatment -- since there is some considerable uncertainly about how much the high viral load does cause trouble, especially in someone with good Cd4 counts. We just are not convinced of what this damage is other than what we see through the Cd4 counts - or at least we accept that while there may be some damage done - it is possible to repair it when someone does go on antivirals - which can be postponed despite a high viral load until the risk of HIV related illness increases - generally speaking when the Cd4 counts get closer to 200.

But this debate - of using viral load versus just the Cd4 count - is a debate without final answers. And this debate is in part what led the US NIH to support the largest ever study in HIV - called the SMART study.

This study aims to compare treatment designed to control HIV viral loads regardless of the Cd4 count with the understanding that HIV at any level is not good for us. And so we maintain control of HIV even at high Cd4 counts. And this is compared with a variation of the strategy you are doing - which is to give the body a rest from antivirals until the immune system needs the "rescue" and the help from these drugs. And in this study there is a restart based only on the Cd4 count/percents - not on the viral loads based on the controversy I've mentioned above. You can read more about that study by clicking on the link.

And so -- what to do? Well - you didn't mention WHY you are taking these treatment interruptions. Are you doing it just to have a break off of antivirals? If so - it is not clear that you'd need to restart with your current numbers - even if the viral load is near 50 thousand and you feel well it is OK to postpone restarting based on what we've seen so far. And the decision about what triggers to use - what Cd4 count, and if we should include viral load in the decision - are among the uncertainties to STI work.

But ultimately a few things are clear -- since we are not sure - we encourage people to discuss with their care providers why they've stopped and what you want to do by restarting - since there are many ways to play this game. And for those who share the uncertainty about stopping versus staying on and want to help researchers ANSWER this question -- one approach is to consider joining a study - such as the SMART study listed above. Since in time we hope to be able to give you a far clearer answer than this one...

OK?



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