Methods: Of the 2,326 participants in the immediate ART arm, 1,982 initiated ART within 30 days of randomization and attended the month 8 follow-up visit. Prior to randomization, participants had 2 screening CD4+ counts > 500 cells/mm3 (SC1 and SC2) within 60 days . Low CD4+ recovery was defined as a CD4+ increase < 50 cells measured from SC2 after 8 months of treatment. We used logistic regression to analyze risk factors for low CD4+ recovery for the 1,883 participants who had an HIV RNA level 200 copies/mL 8 months after initiating ART.
Results: Among patients who achieved virologic suppression 8 months after initiating ART, the median (IQR) CD4+ cell count change at 8 months was +99 (-34.0, +236); 748(39.7%) had low CD4+ recovery. The percent of participants with low CD4 recovery was consistent across stratified levels of SC1 CD4+, ranging from 34.6% to 43.0%. In univariate analyses, race (p = 0.002), geographic location (p = 0.002), and time since diagnosis (p = 0.028) were associated with CD4+ recovery: participants who are African, black, or who were diagnosed more than 5 years before randomization had higher risk for low recovery. Lower baseline log10(RNA) (odds ratio (OR) 1.68, p < 0.001) was associated with an increased risk of low CD4+ recovery. In adjusted analyses, lower baseline log10(RNA) (OR 1.79, p < 0.001), lower SC1 CD4+ count (OR 1.07/100 cell decrease, p = 0.021), and being male (OR 1.55, p = 0.002) were significantly associated with an increased risk of poor CD4+ recovery. After 8 months of follow-up, participants with low CD4+ recovery had CD4+ counts averaging 220 cells lower (95% CI: 206.3- 233.8) than participants with high CD4+ recovery, adjusting for SC2 CD4+.
Conclusion: Low CD4+ recovery in spite of virologic suppression is frequent even among participants starting ART at CD4+ counts > 500 cells. Similar to other studies, we confirm that lower baseline RNA is associated with an increased risk for low CD4+ recovery.
S. Emery, None
D. Mushatt, None
H. Furrer, None
D. Sedláček, None
J. Lundgren, None
J. Neaton, None