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

ObjectivesTo compare the response to highly active antiretroviral therapy (HAART) in individuals starting HAART at different CD4 cell counts. DesignThe 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. ResultsAfter 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 < 200, 201–350 and > 350 × 106 cells/l, respectively. Patients starting HAART with a CD4 cell count < 200 × 106 cells/l tended to have a higher risk of subsequent virological failure [relative hazard (RH), 1.15; 95% confidence interval (CI), 0.93–1.42] compared with patients starting with > 350 × 106 cells/l. There was no difference in risk between the 201–350 and the > 350 × 106 cells/l groups (RH, 1.0; 95% CI, 0.79–1.29). The incidence of new AIDS-defining diseases/death in patients who started HAART with a CD4 count < 50 was 0.03/person-year (95% CI, 0.10–0.33) during the time in which the patient's CD4 cell count had been raised to > 200 × 106 cells/l. ConclusionsThere 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.