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Please Note: Due to volume considerations, not all questions can be answered. Questions most likely to be answered will be those of general interest to a broad group of visitors to this forum. Questions pertaining to a specific case; requests for diagnosis, medical advice, or second opinion; or requests for opinions about untested alternative therapies will generally not be answered.

The participation of Dr. Renslow Sherer in this Forum is made possible in part by an unrestricted educational grant from Abbott Laboratories.

Ask the Experts about Drug Resistance and Staying Undetectable
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Med vacation
Nov 29, 2007

I am a 38 y/o female that has been positve for 8 years. i have had an undetectable viral load for 6 of those years, and a CD4 count of at least 600(currently over 1000). I would like to give my body a break from the meds for like a month or so. Unfortunately, my doctor is on vacation so I cannot ask him about it. What do you think? I am taking Truvada, Reyataz, and Norvir with no real side effects.

Response from Dr. Sherer

I would discourage you from taking any action that might jeopardize this terrific record without talking to your doctor, with whom you have achieved this excellent outcome. A single internet discussion is a poor substitute for a consultation with the physician who knows you best.

There is too much information that I lack that I would want to know to help you make this decision. For example, what was your first ever CD4 cell count and viral load before you started ART? Is this the only ART regimen that you have ever taken? If not, what previous regimens did you take, what happened, and why did you switch? Have you ever had a resistanc test, and, if so, what were the results? Were you ever unable to tolerate HIV medications due to side effects, and if so, what kind, with what medication(s)?

Having said all of the above, I am willing to offer some observations on your question that you should discuss with your doctor when you next see him or her and consider the possibility of a month long drug holiday.

The majority of strategies testing a variety of 'treatment interruptions' have been unsuccessful, i.e. the group in which ART was suspended or interrupted did worse than the group that continued their ART. This is true for all people with advanced disease, for treatment interruptions according to a set schedule (eg one month off, one month off), and for many trials in a setting like your, in which patients who were doing well with viral loads below detection and CD4 cell counts over 350 or 500 cells/ml had their ART suspended until their CD4 cell counts returned to a pre-determined threshold.

In the largest of these trials, the SMART Study, over 5,000 patients enrolled and were randomized into two groups, the viral suppression group in which ART was continued, and the treatment interruption group, in which ART was suspended when the CD4 cell count exceeded 350 cells/ml, and ART was resumed when the CD4 cell count fell below 250 cells/ml. This study was prematurely stopped when the treatment interruption group had more than twice the number of HIV-related clinical events (either opportunistic infections or death) compared to the group that remained on ART. An unexpected finding was that non-HIV serious events such as cardiovascular disease, renal disease, and liver disease were also more than 2x more common in the treatment interruption group compared to the group that remained on ART.

At a minimum, the above information should give you pause and make you think long and hard about the need for a drug holiday compared to the benefits of staying on the regimen that has done so well for you for so long, with your good adherence and your doctor's care.

To summarize the risk of stopping treatment, even for a short time, the principle concerns are recurrence of clinical illness due to HIV or HIV-related conditions, drug resistance, and the possibility that your excellent adherence is altered by your time off medications.

The potential benefits of a drug holiday may include less expense and inconvenience of drug taking, fewer side effects, and your temporary freedom from being constantly reminded of having HIV and needing to take daily medications.

At the same time, there are potential risks and benefits of remaining on ART. The benefits are familiar, in that you have 8 years experience with them. They include a positive long term prognosis, continuation of high CD4 cell counts and complete viral load suppression (as long as you are able to maintain your excellent adherence), and freedom from drug resistance.

The risks of staying on ART include short and long term side effects, drug resistance (if your adherence were to lapse), and the ongoing discouragement of taking daily medications.

My own advice is that you stay on your current regimen.

Based on the findings of the SMART study and other recent studies of CD4-guided treatment interruptions in patients with complete viral suppression and CD4 cell counts above 500, I would advise you and your doctor to consider, AT MOST, a temporary treatment interruption of 2 months or less, in which you plan to resume treatment if and when your CD4 cell counts fall below 350 cells/ml.

And, as above, my own advice is not to do it. With answers to the many questions that I posed above, I might develop more of a willingness to try the treatment interruption....but not enough to change this advice.

And finally, NO, I do not advise you to do this, or even consider this, without talking to your doctor.



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