Impact of earlier HAART initiation on the immune status and clinical course of treated patients on the basis of cohort data of the German Competence Network for HIV/AIDS

Purpose Hitherto, studies on highly active antiretroviral therapy (HAART) initiation have shown partly inconsistent results. Our study investigated the clinical course and course of immune status after HAART initiation at CD4cell-count/ll of treated patients between 250 and 349 (group 1), compared to 350–449 (group 2), on the basis of the cohort of the Competence Network for HIV/AIDS (KompNet cohort). Methods Patients had to be HAART-nao¨ve. Medication had to start at the earliest in 1996, being at least triple combination therapy. The primary endpoints of death, first AIDS-defining illness and first drop of CD4-cell-count/ll below 200 were evaluated as censored event times between the initiation of HAART (t0) and the date of the first event/ date of last observation. Probabilities of event-free intervals since t0 were calculated by Kaplan–Meier estimation, compared by logrank tests. The results were adjusted for confounders using Cox regression. Additionally, incidences were estimated. Results A total of 822 patients met the inclusion criteria (group 1: 526, group 2: 296), covering 4,133 patient years (py) overall. In group 1, 0.64 death cases/100 py were found, with the corresponding vale being 0.17 in group 2. In group 1, 1.38 AIDS-defining events/100 py occurred, whereas it was 0.78 in group 2. In group 1, 2.64 events of first drop of CD4-cell-count/ll below 200 occurred per 100 py, compared to 0.77 in group 2. Kaplan–Meier estimations showed borderline significant differences regarding death (p = 0.063), no differences regarding first