Risk Factors for Low CD4+ Count Recovery Despite Viral Suppression Among Participants Initiating Antiretroviral Treatment With CD4+ Counts > 500 Cells/mm3: Findings From the Strategic Timing of AntiRetroviral Therapy (START) Trial

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/mm3. 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/mm3 from baseline after 8 months despite viral load of <=200 copies/mL. Risk factors for low recovery were investigated with logistic regression. /p> 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/mm3; P = 0.004), higher baseline CD8+ cell counts (OR, 1.05 per 100 more cells/mm3; P < 0.001), and lower HIV RNA levels (OR, 1.93 per log10 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. [ABSTRACT FROM AUTHOR]