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Risks and benefits of starting meds at the onset of infection - START study

Feb 6, 2011

Hi, Ive been HIV + for five years; my viral load is undetectable and my CD4 count is 1230. I decided to start with my medication regimen (truvada/sustiva) at the time of seroconvertion (viral load was 80,000 and CD4 was about 900. My decision was based on the fact that I had a history of cancer and I was afraid that it was going to return. However, now that Ive been reading studies on HIV/AIDS, books on immunobiology, and other articles Ive discovered that there are conflicting conclusions with regards to starting HIV meds. Some old studies note that patients should start meds when their CD4 count reaches 300 and that initiating medication should be delayed due to the long-term possibility of the virus becoming resistant or mutating. However, according to Kenneth Murphy, Paul Travers, and Mark Walport (Immunobiology-2008), since HIV rapidly develops resistance to antiviral drugs it might be important to begin treatment early in the course of an infection, thereby reducing the chance that a variant virus will have accumulated all the mutations necessary to resist the entire cocktail. In addition, initiating treatment during the early phase also helps to protect the immune system. So what is the correct information? In my case, have I made the wrong decision in starting meds very early? Or perhaps each HIV + individual is different (i.e., medication effectiveness, side effects, liver enzyme function, health history, etc.?

Response from Dr. Pierone

Hello, and thanks for posting.

We don't know the best time to start HIV medication. There has been a trend towards earlier treatment as the medications have improved. The expert panel that formulates the DHHS guidelines was split about evenly on the recommendation to consider initiation of antiretroviral treatment with a CD4 count above 500.

There are observational studies that suggest that commencement of HAART any time after HIV infection is beneficial. However, we do not yet have definitive data from a randomized, controlled trial to support early initiation of antiretroviral treatment. The good news is that eventually we will get clarity on this topic.

There is an NIH trial called START that is well underway and this goal of this undertaking is to help answer this crucial question. The study has already enrolled over 1000 patients and the plan is to enroll over 4000 treatment-nave patients with more than 500 CD4 cells over the next 2 years. Subjects will be randomly assigned to either start immediate HAART or to defer treatment until the CD4 count drops to 350. Results from the trial will not be available for a number of years. Until that time, the decision to start early antiretroviral therapy should be made on an individual basis.

One of the exclusion criteria for the START study is a history of previous cancer (other than minor skin cancers). The reason for this exclusion is because of the known importance of the immune system in preventing relapse or development of cancer. Since you did have a history of cancer it seems entirely reasonable that you decided to start treatment early.

Good luck and stay tuned!

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