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Think About It

Arriving Too Soon: Suggestions for the Coming Generation of "Heavily Treated" Patients

September 2000

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

Dear Prospective Heavily Treated Patient,

You don't know it yet, but you will read about yourself in the pages of POZ or elsewhere, and you'll do it soon. No, the authors won't refer to you by name. But here's the clue that it's you they're writing about: look for the phrase "heavily treated patient." You may not know exactly what that means. But you will probably have a vague sense, reading terms like "salvage" and "rescue," that trouble is near.

In HIV vocabulary, "heavily treated" usually refers to a patient who has taken 2 or more antiretroviral regimens and experienced viral rebound on both. Since you'll no longer belong to the coveted class of "naïve" patients, the pharmaceutical industry will lose its previously lustful look at you. You'll be left largely to your own devices, to the skill of your physician -- let's hope he or she has a lot of HIV-related experience -- and to the empathic efforts of a handful of treatment activists.

If your nature is contemplative, you might wonder how it is, only a year or two after you began treatment, that you have come to be without viable treatment options. After all, aren't there 16 drugs on the market? Probably no one told you that 16 drugs often translate into not more than 2 effective regimens. If your CD4 T cell count is high and you've never had an HIV-related illness, you may even wonder what you were doing taking the drugs in the first place. Probably no one also told you that the median CD4 count at the time of the first AIDS-defining event is 60 cells/mm3 and that only 10% of all AIDS-defining events occur in people with CD4 T cell counts of 200 cells/mm3 or greater.1

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When you started treatment, back when you were feeling well before the drugs made you sick, you may have believed that medical decisions are rooted firmly in facts and evidence. It might therefore come as a surprise to learn that no one has ever conducted a study to see whether people with CD4 T cell counts above 350 cells/mm3 live longer or have fewer illnesses as a consequence of taking highly active antiretroviral therapy (HAART). You may have had the sense that pharmaceutical company profits influenced the decision of when to start treatment and what treatment you received, but you probably underestimated the pervasiveness of that influence.2 Still, depending on what's been done to you so far, it may not be too late to prevent, or at least begin to reverse, the damage that could await you. Here are some ideas.

Keep in mind that, as with any drug change, you will probably need a new regimen and not just a new drug to regain control of your viral load. Therefore, whenever possible, it makes sense to wait and construct a viable regimen when more than one new agent is available and not use new drugs one at a time. The sequential use of new treatments is like taking monotherapy.

Whatever you may have heard, an undetectable viral load is not clinically necessary but it is usually therapeutically necessary. Under the natural history of HIV infection, individuals with a viral load of less than 5000 copies/mL, which is far from undetectable, rarely experience HIV disease progression. However, it is well established that failure to achieve and maintain a viral load of less than 50 copies/mL is likely to result in future virologic rebound. Therefore, even though an undetectable viral load is not necessary to remain healthy in the short term, it still makes sense to maximally suppress plasma HIV RNA whenever possible if you're on a HAART regimen. Maximal suppression is a tactic for preventing or delaying the emergence of drug-resistant virus and, consequently, for preserving future treatment options. Viral load generally predicts the speed at which your CD4 T cell count will decline and it measures how well your drugs are working. But it rarely says anything about your health today.

If you have experienced viral rebound on 2 prior regimens, it is unlikely (less than a 1 in 3 chance) that you can regain an undetectable viral load using the therapies now available. Therefore, if you are on a third regimen, select a therapeutic goal that's realistic for you, e.g., reducing your viral load by 0.5 log or more from baseline.

If you are on a third regimen and unable to reduce your viral load, there is evidence that antiretroviral therapy still may help you. Data from San Francisco General Hospital show that therapy provides a clinical and immunologic benefit for 2 years or longer in many patients whose plasma viremia is not well controlled. Antiretroviral therapy may have a clinical benefit independent of its ability to suppress viral load.

Adherence is the most important factor associated with the virologic success of therapy. Data presented by Margaret Chesney, PhD, suggest that 95% adherence is necessary for sustained viral suppression. If you are unable or unwilling to adhere to your current regimen, consider changing it. If you are having trouble adhering to a standard 3-drug regimen, talk to your doctor about taking 2 nucleoside reverse transcriptase inhibitors (NRTIs) only. If you are not yet heavily treated and have a moderate to high CD4 T cell count, you can put together a dual NRTI combination that involves few pills, no food restrictions and twice daily dosing. The doctor will say that's heresy, that 3-drug therapy is best and that 2 NRTIs alone are likely to select for virus resistant to that whole class. That's all true -- and irrelevant. Investigators have demonstrated that a dual NRTI strategy provides clinical benefit, and it leaves the powerful protease inhibitors and non-nucleoside reverse transcriptase inhibitors available for later use, when your T cell count is lower and you need potent therapy.

If you are unable or unwilling to adhere to any antiretroviral regimen, one other option, depending on your baseline CD4 T cell count and viral load, is to withdraw from therapy altogether until you are ready to commit. Provided your CD4 T cell count was above 250 cells/mm3 at the time you started treatment, if you quit treatment now it's very unlikely that you will experience HIV disease progression in the short term. But if you decide to stay on treatment, know that taking some of your medication some of the time does more harm than good.

Particularly if you receive care from a large clinic, where a different student or resident sees you every time, maybe no one ever instructed you in detail on how to take your drugs. And it's almost certain, wherever you receive care, that no one has told you about the option of taking fewer than 3 drugs, or even taking no drugs at all. You may have believed that all the choices were explained to you. But being drug naïve is one thing; being naïve about your treatment choices is another.


References

  1. Bartlett JG, Gallant JE. Medical Management of HIV Infection. Baltimore, MD: Johns Hopkins University, Department of Infectious Diseases; 2000:21.

  2. Angell M. The Pharmaceutical Industry-To Whom Is It Accountable? N Engl J Med. 2000;342(25):1902-1904.


Back to the RITA! September 2000 contents page.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by The Center for AIDS. It is a part of the publication Research Initiative/Treatment Action!. Visit CFA's website to find out more about their activities and publications.
 
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