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Restarting Therapy
Oct 7, 2001

Dear Dr Cohen:

About 6 months ago I took a break for treatment, and now think it's time to go back.

I was on a Combivir & Efavirenz combination, and although I was very happy with the results (T4 was 600+, Viral Load was >50 within 1 month) there were a lot of side effects that I wasn't happy about. Specifically: high triglyceride levels, serious sleep problems and wild mood swings.

I have discussed this with my doctor and she recommends Combivir with Nevirapine. I have a few questions about this.

There is no reason to suspect any drug resistance problems, but is it a good idea to go back on one of the previous drugs but not the other?

What side effects can I expect with the nevirapine?

I know that there isn't a whole lot of hard data on STI's, but do you have any ideas as to an optimum time to be off and then to be back on medication? At this point I'm thinking of going on medications for about 6 - 8 months and then a 3 - 4 month break. Does this make any sense?

Thanks again for all your help.

Response from Dr. Cohen

Well, it isn't clear what your goal was for your treatment interruption - and there are two broad categories for the "long" interruptions that you are doing (as opposed to the one week off shorter interruptions also being tested.)

One category of interruption is simply to minimize the amount of time you are on antivirals, in order to minimize drug toxicity over the years. And of course, at the same time, prevent any HIV related illnesses. The key to this approach is to maintain a "protective" CD4 count, and maintain an effective treatment option when you do need to restart. Now, there is some debate about specific numbers, but there is a large international trial about to begin that is testing just this strategy - using a restart criteria of a CD4 count of about 250. Where did this number come from? Mainly it comes from studies showing that people with a CD4 count above this don't have any appreciable increased risk of illnesses due to HIV. And this count is chosen both to give the longest time off meds, as well as be protective to people in the study. And when people restart, the meds should work just as well for those with this count as it does for those with higher counts. And the expectation is that those who start at 250 regrow back to normal counts just fine. And so this number is what is used in several European, Canadian, and Australian guidelines as the time to start treatment for HIV.

But in the US, 250 is a count somewhat lower that where we have started - we usually are more comfortable at 350. There are certainly no clear answers as to which number is better - and that is what prompts this study - comparing in part these two values as the time to treat.

So one answer to your question of when to restart - is which CD4 count would lead you to want to restart. Using an arbitrary number of months is more difficult to use - since it more depends on what happens in the 3-4 months you are off - if all is fine, then do you need to restart? You can, but it is optional...

Now, there is another reason to do interruptions. That is to try and stimulate an immune response to HIV itself. This seems to "work" for perhaps 20% of those who have done it - and it is still early on to know what approaches are best. But here, the parameters that are used include both time off, but more so a a specific viral load that is used to judge when to restart. Since it is thought that low viral loads might stimulate some immune response in some people, whereas higher viral loads might cause more damage to these cells. Here, our knowledge is still early - so the values used are fairly arbitrary, but somewhere above a viral load of 10-50 thousand is used as a signal to restart.

As for what to start on - if you have side effects on efavirenz, and they did not resolve in time, then a frequent next choice is nevirapine. There is some initial monitoring that must be done when starting - checking mainly the liver function tests, and checking for a rash, since the initial month can rarely have some more serious side effects in a few. One more caution however, is that those who have stopped nevirapine type combinations have reported a possibly higher rate of resistance to the nonnucleoside family of antivirals as a result of the interruption. So if the time comes for another interrption, you may wish to consider some approaches to protecting the nevirapine from resistance. This for example could include starting a protease inhibitor for a week when stopping just the nevirapine, and then stopping the whole combo.

Hopefully that does make some sense in planning your next steps. Good luck.



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