Treatment interruption of highly active antiretroviral therapy in patients with nadir CD4 cell counts >200 cells/mm3

Abstract

Background. The goal of the present study was to characterize outcome and predictors of outcome of treatment interruption (TI) in highly active antiretroviral therapy (HAART)-treated patients. Methods. A systematic chart/database review was conducted to identify patients with nadir CD4 cell counts >200 cells/mm3 and without acquired immunodeficiency syndrome-defining illnesses who underwent a TI. Collected data included duration and reason for TI, demographic characteristics, CD4 cell count, and plasma viral load. Human immunodeficiency virus (HIV) envelope (V3) loop genotyping was performed on plasma HIV RNA. The presence of basic residues at aa 11 and/or 25 (the "11/25" genotype) was a further possible prognostic variable of interest. Cox proportional hazards models were used to assess characteristics associated with time to HAART reinitiation after TI. Results. A total of 208 of 4461 (4.7%) patients underwent TI. The study group consisted of 197 (94.7%) of 208 participants for whom V3 genotyping was successful. The median CD4 cell count at time of the initiation of TI was 620 cells/mm3. A total of 59 (29.9%) patients reinitiated HAART after a median of 15 months. At the time of the reinitiation of HAART, the median plasma viral load was >100,000 copies/mL, and the median CD4 cell count was 260 cells/mm3. Among the 197 study patients, there were 6 deaths, none of which was attributable to the TI. A total of 81% had plasma viral loads <50 copies/mL by 15 months of follow-up after reinitiation of HAART. In multivariate analysis, a nadir CD4 cell count ≤250 cells/mm3 (risk ratio [RR], 2.79 [95% confidence interval {CI}, 1.60-4.86]; P 250 cells/mm3. A nadir CD4 cell count of 200-250 cells/mm3 and the 11/25 viral genotype were found to be associated with a faster HAART reinitiation. © 2005 by the Infectious Diseases Society of America. All rights reserved.