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High viral load, High CD4 count
Jun 12, 2008

I'm not on medications and for the last year my viral load has been 70,000 or higher. At the same time, my CD4 count has remained steady, hovering around 580 with an also steady percentage of around 30. I'm concerned about the high viral load and the effects it may have. Is it advisable to start treatment?

Response from Dr. DeJesus

That is an excellent question, and the source of extensive investigation. In theory, it appears very clear that starting anti-HIV treatment at any CD4 count and viral load (no matter how high or low) may be logical and beneficial. But there are many other factors to consider that make that answer indeed not that simple.

Initially, because HIV treatments were associated with many adverse effects, initiation of therapy was not recommended for HIV infected persons until the CD4 count was <250 cells/mm3. This starting CD4 number was then increased to <350/mm3 cells, after the drugs used to treat HIV infection became safer, and the benefits of starting anti-HIV therapy became clearly beneficial. Current guidelines, based largely on data from cohort studies, recommend initiating anti-HIV therapy with CD4 count <350 cells/mm3.

In the past few years HIV treatments have become even safer, and new data generated from epidemiological studies are staring to demonstrate that patients starting therapy even at higher CD4 counts (>350 cells/mm3) may suffer from less medical complications at a long term. HIV viral loads have also been found to play an important role in predicting future outcomes, with patients with HIV viral loads very high (i.e. >100,000 copies) at greater risk for faster progression. With the data that we have available so far from clinical studies we can make a firmed recommendation that those patients with CD4 count >350 cells/mm3 (but below 500 cells/mm3) and HIV viral loads elevated (i.e. >100,000 copies), initiation of anti-HIV therapy should be considered.

There is a very strong possibility that patients with even higher CD4 counts (>500 cells/mm3) and lower HIV VL (<100,000 copies) may also benefit at a long term from initiation of anti-HIV therapy. I personally believe that those patients, like you, will benefit from initiation of therapy, but there is no definitive clinical data from studies to confirm this theory.

A new study sponsored by the NIH, called the START Study, and scheduled to start enrolling patients later this year has been specifically designed to answer that question you have posted. This study will enroll HIV positive patients with CD4 counts >450 cells/mm3 from all over the world, including several cities in US. Those patients will be divided into two groups: one that will start therapy immediately at their high CD4 count. The second group will start therapy at the currently recommended level of 350 cells/mm3. You may want to check the INH study website: http://clinicaltrials.gov/ct2/show/NCT00595192?id=NIAID&rank=13 and get information about the locations where this study will be conducted, and perhaps consider participation. But, if you are not interested in participating in this study, the answer for your question is as follow: current guidelines recommend you to wait until the CD4 is <350 cells/mm3; but if it is me, I will not wait until my CD4 count is that low. Good luck!



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