Initiation of antiretroviral therapy at CD4 cell counts >= 350 cells/mm(3) does not increase incidence or risk of peripheral neuropathy, anemia, or renal insufficiency

Background: US guidelines recommend deferring initiation of highly active antiretroviral therapy (HAART) for most patients with CD4 counts >350 cells/mm(3) in part because of concerns about antiretroviral toxicity. Methods: Incidence rates of peripheral neuropathy, anemia, and renal insufficiency in a cohort of 2165 patients followed more than 3 years (mean) were analyzed in multivariate Cox proportional hazards models by CD4 cell counts at initiation of HAART. A nested cohort of 895 patients restricted to study participants who did or did not start HAART within a CD4 cell count stratum were also compared. Results: Incidence and risks of all 3 comorbidities decreased with initiation of HAART at CD4 counts >200 cells/mm(3) versus <200 cells/mm(3). Incidence and risks of renal insufficiency were similar with HAART initiation at CD4 counts >= 350 cells/mm(3) versus 200 to 349 cells/mm(3), but risk of peripheral neuropathy and anemia were further decreased in persons starting HAART at a CD4 count >= 350 cells/mm(3). The incidence of these conditions was highest during the first 6 months of treatment at any CD4 cell count and declined up to 19-fold with further therapy. Discussion: Initiating HAART at CD4 cell counts >= 200 cells/mm(3) reduced the incidence and risk of the 3, comorbid conditions and for anemia and peripheral neuropathy as well by starting at CD4 counts >= 350 cells/mm(3). The incidence of each condition decreased rapidly and remained low with increasing time on HAART.