Purpose of review: 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.
Recent findings: 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.
Summary: 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.