Should HIV therapy be started at a CD4 cell count above 350 cells/microl in asymptomatic HIV-1-infected patients?

The aim is to review the available data that contribute to the debate on the optimal time to initiate highly active antiretroviral therapy (HAART) in HIV-infected individuals with a CD4 cell count more than 350 cells/microl.

Although few randomized data exist that can contribute to this debate, a number of findings from observational studies generally support earlier initiation of HAART. In particular, the findings that death rates remain higher in HIV-infected individuals than in uninfected individuals, even when successfully treated, and that both AIDS and several serious non-AIDS events are more common in those with a lower CD4 cell count (even when this count is above 350 cells/microl), suggest that earlier initiation of HAART may prevent much of the excess morbidity and mortality that remains in this patient group.

Currently, the data would generally support initiation of HAART in patients with CD4 cell counts more than 350 cells/microl. However, given the strong potential for confounding in observational studies and the lack of adjustment for lead-time bias in many analyses, it is not possible to rule out possible long-term detrimental effects of earlier use of HAART until the results from fully powered randomized trials that directly address this issue become available.