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Do I do a protocol???? PLS HELP, I'M CONFUSED!
Jun 11, 2000

Dear Dr. Cohen,

First, my infinite thanks for your time and expertise! I was diagnosed HIV+ in Sept. '99 with viral load at 180,000 and CD4 at 47. I was put on Viracept, Epivir and Zerit, and have subsequently hovered around CD4 250, and viral load 200 for the past 9 months since I started this regimen. Last week, my viral load went to 2000 and my cd4 to 240. My doctor said that because my viral load went from 200 to 2000, that I have probably become resistant to one or more of the drugs, and that I should try a new protocol (i don't remember the name of the new med). My question is why would I go on a protocol, if I have not even tried the other meds out there yet. I thought protocol/clinical trials were reserved for people that have exhausted all existing meds? and what is your opinion of this viral jump? Is this a really bad sign? if i am resistant to the drugs, can i never use them again? i have never missed a dose, and have always taken them on the dot, so how could it mutate? please help me, I'm so confused!

thank you!

Response from Dr. Cohen

Well, we've learned a few lessons from the past few years of studies.

First - is that those who start meds with a viral load that is "high" like over 100,000 have a lower chance of seeing viral suppression to below 50 copies on many standard triple combination regimens. This would be true for the combination you mention and others like it that contain one PI and two nucleosides. (This decrease in success rates at high viral loads is not a problem when using combinations that use Sustiva and two nukes. This may also be true for nevirapine/viramune as well... although that latter is less proven.) And your CD4 count was also lower when you started and that too appears to have an impact in making these combinations less successful. So for that reason, we have since considered that those with your initial numbers might be more successful if we start some enhanced potency combination usually using 4 antivirals, or one that uses norvir/ritonavir to boost the levels of a second PI.

Second lesson we've learned is that unless the viral load gets to below 50, there is a fairly high risk of seeing viral load rebound. While 200 is low, it means that 200 copies of HIV were growing in every drop of blood and these virus particles were doing what they could to ignore the meds and eventually were able to do just that. So now what?

Well - I don't know what protocol your MD is considering for you and it sounds like you don't either. Sometimes a protocol is available for people in your circumstance because we have reasonable options, but a study is providing a new option that hopes to be at least as good if not better than what we do in our standard approach. Some studies provide meds that are approved already, while others provide access to a newer medication as a comparison to what is already available by prescription. And some protocols provide a test - like a resistance test - either instead of meds, or in addition to meds. Just because your provider is considering a protocol doesn't mean you are in big trouble - as you mention we have several clinical approaches with a fairly high expectation of success. It may be however that the protocol is trying to improve on what we now do, by comparing our standard to something new.

You clearly need to raise your concern with the provider as to what the advantages and disadvantages are of this protocol. It may be that once you spend time to understand, and ask your questions, you still may want to do what we would do if we didn't have a protocol available. You should certainly ask what you would do if you were not going with the protocol. However - it may be that once it is clearly explained, you're interested enough to join. These days, all studies have a clear consent form to explain the options to you.

Good luck.

Cal Cohen, M.D., M.S.



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