Initiation of Antiretroviral Therapy at CD4 Cell Counts ≥350 Cells/mm3 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 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 versus <200 cells/mm. Incidence and risks of renal insufficiency were similar with HAART initiation at CD4 counts >/=350 cells/mm versus 200 to 349 cells/mm, but risk of peripheral neuropathy and anemia were further decreased in persons starting HAART at a CD4 count >/=350 cells/mm. 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 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. The incidence of each condition decreased rapidly and remained low with increasing time on HAART.