This is from a posting by NAM. It is well considered. You can read the entire posting on the web or email the [him] moderator and he will email it to you.

[him] moderator

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Making sense of it all

Again, different programmes may take home different messages from these studies, however a few things seem clear.

    * Support adherence! If adherence is near perfect, during the first few years on ART, the majority of patients will do well, regardless of how the regimen’s effectiveness is monitored.
    * Routine laboratory monitoring, whether by viral load or CD4 cell counts, may provide an early indication of whether the patient is not taking their treatment, allowing for intensive adherence interventions, which could preserve the first line regimen. Viral load is by far the most sensitive measure but even CD4 counts may detect patients who have stopped or never started taking their medications. The question for HIV programmes is whether it is cost effective (and whether the capacity exists or can soon be developed) to perform viral loads to detect and respond to poor adherence problems or to detect early failure. If adherence is generally good at a site, then testing everyone may not be the most cost-effective way to identify the few who are poorly adherent. The answer may be different at sites where patients get less time with a healthcare worker.
    * At the very least, viral load may be needed to confirm which patients are truly failing — especially in light of the extremely high cost of second line therapy. This might be the foot in the door for viral load testing, then as capacity increases, and the logistics are worked out, or more inexpensive point-of-care assays are developed, viral load monitoring could become more routine with time.
    * Even if routine viral load monitoring was available everywhere, it isn’t absolutely clear what threshold of viral load should be used to make the decision to switch the second-line treatment (we will discuss this more in an upcoming article on antiretroviral resistance in resource limited settings).
    * CD4 cell testing should be made available everywhere, because it really is an indispensable tool for making a number of treatment decisions including when to start, when to provide more support, whom to monitor more closely, and probably when to switch as well. “We may have to start thinking about a using combination of CD4 counts, viral loads and clinical criteria that might then in combination provide us with even better clinical outcomes,” said Dr Mermin in Kigali. Indeed. 25 years of clinical research have demonstrated that CD4 cell counts are the best predictor of a person with HIV’s risk of imminent clinical progression to severe illness or death.
    * In settings that cannot yet afford or yet handle the logistics of routine viral load, it may be possible to refine screening algorithms so that they are more sensitive or specific for virological failure. Some clinical endpoints, in particular PPE, might be good early indicators of a virological failure before immunological decline, but these obviously won’t occur in every failing patient. CD4 cell counts could help, especially if paired with other markers of immune activation such as CD38.

Many experts believe that all these apparent contradictions and controversies will only be resolved by further study — and we fully support operational research and the sharing of best practices from resource limited settings.

But before launching into any large simple trials in thousands of people with HIV that will take years to complete, we need to ask ourselves: What are we randomising people to and why?

If we really want to know the best failure criteria to use for switching when there is only one other switching option available, then we should think about whether those studies would be necessary if third and fourth line ART regimens were available.

It is not acceptable that people in resource -limited settings have to settle for just two ART regimens. It took four to five years for triple drug combination therapy to start being made available in Africa. Why should it take 10 to 20 years to get access to the newer drugs being used in the West? The drugs exist.

What is the point of ‘universal’ treatment access if it only lasts three to six years?

Ultimately, the monitoring strategy that is chosen depends upon what policy makers believe the future holds. Its up to us as advocates to make sure that future is bright.

http://www.aidsmap.com/cms1037059.asp