Southern African treatment guidelines retain CD4 threshold of 350 for starting ART (2013)

The following statement from the SAHCS is important given the recent focus on the evidence supporting the clinical benefits of earlier treatment, especially following the WHO guidelines increasing the CD4 threshold to 500 cells/mm³. [1]

SAHCS statement on WHO consolidated guidelines

The Society notes the WHO’s new guideline threshold of 500 cells/mm³ for the initiation of antiretroviral therapy in asymptomatic, non-pregnant adults.

There is no additional new data to support changing our own guideline, but we acknowledge the WHO recommendation may cause confusion. Several on-going clinical trials will complete within the next few years. These will help inform when to start, both from an individual patient and public health perspective. We therefore suggest clinicians consider the following when making treatment decisions.

There are clear individual benefits (reduced mortality and tuberculosis) for starting ART in any patient with a CD4 below 350 cells/mm³ based on the findings of a randomised controlled trial. There is sufficient evidence to suggest any patient regardless of CD4 count who has chronic active hepatitis B, tuberculosis or any other significant clinical condition (as described in our 2012 adult ART guidelines) will benefit from ART initiation above the 350 threshold. There is also clear benefit associated with using ART above this threshold for preventing MTCT, and for treating the positive partner in a serodiscordant sexual partnership to prevent transmission to the HIV-negative sexual partner.

The data for individual benefit above 350 cells/mm³ is based almost entirely on observational cohorts, which have inherent biases, and these data are from developed countries. Even where benefit is shown, this is relatively small.

Complications of earlier treatment include more drug toxicity and potential for resistance due to longer periods on ART, as well as vulnerability to ART interruptions in a climate of international and local drug stock outs.

Epidemiological data suggesting broader ART coverage has a beneficial impact on reducing HIV incidence in communities is compelling but unproven, and should not influence decision making at an individual level unless such an approach was adopted as a large scale public health strategy.

We believe initiating treatment above 350 cells/mm3 is a highly individualised decision that should take into account the patient’s clinical condition, their wishes and their motivation, after a careful explanation of the risks, possible benefits and financial burden that may result if self-funding.