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 Treatment (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 > 500 cells/mm.

SETTING: United States, Africa, Asia, Europe & Israel, Australia, Latin America.

METHODS: Among immediate-ART participants in the Strategic Timing of AntiRetroviral Therapy trial, low CD4+ recovery was defined as a CD4+ increase < 50 cells/mm from baseline after 8 months despite viral load ≤ 200 copies/mL. Risk factors for low recovery were investigated with logistic regression.

RESULTS: 39.7% of participants had low CD4+ recovery. Male gender (OR 1.53, p = 0.007), lower screening CD4+ (OR 1.09 per 100 fewer cells/mm, p = 0.004), higher baseline CD8+ (OR 1.05 per 100 more cells/mm, p < 0.001), and lower HIV RNA (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 μg/mL. At lower HIV RNA levels, odds of low recovery were elevated across levels of screening CD4+ count, but at higher levels, odds of low CD4+ recovery were greater among those with lower versus higher screening CD4+.

CONCLUSION: Low CD4+ recovery is frequent among participants starting ART at high CD4+ counts. Risk factors include male gender, 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.