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TreatmentUpdate 172

Volume 21 Issue 3

2009 March/April

I ANTI-HIV AGENTS - C. Should HAART begin right after an HIV diagnosis?

Also exploring the issue of when is best to begin HAART is a group of researchers in Canada and the United States called the NA-ACCORD (the North American AIDS Cohort Collaboration on Research and Design). These researchers have joined 22 data sets to produce the NA-ACCORD, which contains health information collected from more than 9,000 HIV positive people.

Co-infections included

Like counterparts elsewhere, the NA-ACCORD team used its database to create a virtual clinical trial, hoping to assess the effect of either immediately initiating treatment after diagnosis or deferring treatment in people with CD4+ counts greater than 500 cells until their counts fell below the 500-cell threshold. In total, 2,616 people were assigned to immediately begin HAART and 6,539 people were assigned to delay starting HAART. None of the participants had previously used anti-HIV drugs. What makes the analysis from the NA-ACCORD interesting is that unlike ART-Cohort Collaboration, the North American researchers included people who were co-infected with hepatitis C virus (HCV).

The average profile of this study’s participants who began therapy immediately was as follows:

• 82% male, 18% female
• age – 40 years
• CD4+ count – 674 cells
• viral load – 5,000 copies
• hepatitis C virus co-infection – 25%

The major difference between this group and the people who delayed therapy was that the second group did not begin therapy until their CD4+ count was about 390 cells. This assumption takes into account that in many high-income countries today most HIV positive people appear to delay therapy.

Results—deaths

There were 196 deaths in people who began therapy immediately vs. nearly twice as many deaths (410) in people who delayed therapy until their CD4+ counts fell below the 500-cell mark. Other findings from this study were as follows:

• Overall, the risk of death was reduced by 60% when people began therapy at CD4+ counts of 501 or higher.
• For each decade of increased age, the risk of death rose by 60%. This is due to a number of reasons, perhaps chiefly because the immune system tends to degrade with age, regardless of HIV infection.
• The risk of death remained the same whether or not HCV co-infection was taken into account or not.

The causes of death whether people started therapy immediately or delayed initiation were mostly as follows:

• cardiovascular disease (heart attack and stroke)
• liver related (mostly due to complications of hepatitis caused by HCV infection)

The results of this study support the initiation of HAART at earlier time points in the course of HIV infection—when CD4+ counts are relatively high, perhaps even shortly after HIV infection has been diagnosed. However, these results are based on data from an observational study, and such studies cannot entirely eliminate the possibility of bias when interpreting their results. Although this and other studies make a strong case for the more immediate use of HAART, they do not take into account the psychological effect of an HIV diagnosis or the news that treatment should begin shortly after such a diagnosis and the possible impact these might have on a person’s mental health and ability to initiate and be highly adherent to HAART.

When to start?

Perhaps further clarity as to the ideal time to start HAART will emerge from an international clinical trial that is being planned. START—Strategic Timing of Antiretroviral Treatment—is sponsored by the American National Institutes of Allergy and Infectious Diseases (NIAID) and will be a randomized clinical trial. START is expected to begin recruiting potential participants later in 2009. Participants will have a CD4+ count of at least 501 cells and will be randomly assigned to one of the two following groups:

• immediate HAART
• delayed HAART until the CD4+ count falls below 350 cells

The study is expected to last for up to six years and researchers mainly will be assessing so-called hard endpoints, such as the development of AIDS-related and non-AIDS-related complications and/or death.

Created on: 2009 May 1

Author: Hosein SR

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