Objective: Few data describe antiretroviral treatment (ART)-related adverse events
when treatment is initiated at CD4þ cell counts more than 350 cells/ml. We compared
rates of laboratory-defined adverse events (LDAEs) according to CD4þ cell count at ART
initiation.
Design: Analysis of on-going cohort study.
Methods: ART-naive persons initiating ART from 2000 to 2010 were included. Chisquare,
analysis of variance (ANOVA) and Kruskal–Wallis tests compared characteristics
among those starting ART with a CD4þ cell count of 350 or less, 351–499 and at
least 500 cells/ml. Time-updated Poisson regression compared rates of LDAE in the three
CD4þ cell strata. Cox proportional hazard models compared risk of ART discontinuation.
Results: Nine thousand, four hundred and six individuals were included: median age
37 years, 61% white, 80% men, median viral load 4.8 log copies/ml. Four hundred and
forty-seven (4.9%) and 1099 (11.7%) started ART with a CD4þ cell count at least 500
and 351–499 cells/ml, respectively. One thousand, two hundred and eighty-three
(13.6%) patients experienced at least one LDAE. The rate of LDAE did not differ
between those starting ART with a CD4þ cell count 351–499 and less than 350 cells/ml
[relative rate 0.90, 95% confidence interval (CI) 0.74–1.09)], but an increased risk of
ART discontinuation was observed (hazard ratio 1.58, 95% CI 1.10–2.27). Those
starting ART at CD4þ cell count at least 500 cells/ml had an increased rate of LDAE
(relative rate 1.44, 95% CI 1.13–1.82) but were not more likely to discontinue ART
(hazard ratio 1.15, 95% CI 0.64–2.09).