When to start highly active antiretroviral therapy in chronically HIV-infected patients: evidence from the ICONA study

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Abstract
To compare the response to highly active antiretroviral therapy (HAART) in individuals starting HAART at different CD4 cell counts. The mean increase in CD4 cell count and rate of virological failure after commencing HAART were measured in antiretroviral-naive patients (1421) in a large, non-randomized multicentre, observational study in Italy (ICONA). Clinical endpoints were also evaluated in a subset of patients who started HAART with a very low CD4 cell count. After 96 weeks of therapy, the mean rise in CD4 cell count was 280, 281 and 186 × 106 cells/l in patients starting HAART with a CD4 cell count 350 × 106 cells/l, respectively. Patients starting HAART with a CD4 cell count 6 There was no clear immunological or virological advantage in starting HAART at a CD4 cell count > 350 rather than at 200–350 × 106 cells/l. The increase in CD4 cells restored by HAART is meaningful in that they are associated with reduced risk of disease/death.