Risk Factors for Low CD4(+) Count Recovery Despite Viral Suppression Among Participants Initiating Antiretroviral Treatment With CD4(+) Counts > 500 Cells/mm(3): Findings From the Strategic Timing of AntiRetroviral Therapy (START) Trial
Abstract
Background: Low CD4(+) recovery among HIV-positive individuals who achieve virologic suppression is common but has not been studied among individuals initiating treatment at CD4(+) counts of >500 cells/mm(3). Setting: United States, Africa, Asia, Europe and Israel, Australia, Latin America.
Methods: Among participants randomized to immediate antiretroviral therapy (ART) in the Strategic Timing of AntiRetroviral Therapy trial, low CD4(+) recovery was defined as a CD4(+) increase of <50 cells/mm(3) from baseline after 8 months despite viral load of <200 copies/mL. Risk factors for low recovery were investigated with logistic regression.
Results: Low CD4(+) recovery was observed in 39.7% of participants. Male sex [odds ratio (OR), 1.53; P = 0.007], lower screening CD4(+) cell counts (OR, 1.09 per 100 fewer cells/mm(3); P = 0.004), higher baseline CD8(+) cell counts (OR, 1.05 per 100 more cells/mm(3); P < 0.001), and lower HIV RNA levels (OR, 1.93 per log(10) decrease; P < 0.001) were associated with low CD4(+) recovery.
D-dimer had a quadratic association with low CD4(+) recovery, with lowest odds occurring at 0.32 mu g/mL. At lower HIV RNA levels, the odds of low CD4(+) recovery were elevated across the levels of screening CD4(+) count; but at higher HIV RNA levels, the odds of low CD4(+) recovery were higher among those with lower vs. higher screening CD4(+).
Conclusions: Low CD4(+) recovery is frequent among participants starting ART at high CD4(+) counts. Risk factors include male sex, lower screening CD4(+) cell counts, higher CD8(+) cell counts, and lower HIV RNA levels.
More follow-up is required to determine the impact of low CD4(+) recovery on clinical outcomes.