Better Virological Outcomes amongst People Living with HIV Initiating Early Antiretroviral Treatment (CD4 counts ≥ 500 cells/µL) in the HPTN 071 (PopART) Trial in South Africa

BACKGROUND: There have been concerns about reduced adherence and human immunodeficiency virus (HIV) virological suppression (VS) among clinically well people initiating antiretroviral therapy (ART) with high pre-ART CD4 cell counts. We compared virological outcomes by pre-ART CD4 count, where universal ART initiation was provided in the HIV Prevention Trials Network 071 (PopART) trial in South Africa prior to routine national and international implementation. METHODS: This prospective cohort study included adults initiating ART at facilities providing universal ART since January 2014. VS ( 1000 copies/mL), and viral rebound were compared between participants in strata of baseline CD4 cell count. RESULTS: The sample included 1901 participants. VS was >/=94% among participants with baseline CD4 count >/=500 cells/microL at all 6-month intervals to 30 months. The risk of an elevated viral load (>/=400 copies/mL) was independently lower among participants with baseline CD4 count >/=500 cells/microL (3.3%) compared to those with CD4 count 200-499 cells/microL (9.2%) between months 18 and 30 (adjusted relative risk, 0.30 [95% confidence interval, .12-.74]; P = .010). The incidence rate of VF was 7.0, 2.0, and 0.5 per 100 person-years among participants with baseline CD4 count /=500 cells/microL, respectively (P /=500 cells/microL (adjusted hazard ratio [aHR], 0.23; P = .045) and 3-fold higher among those with baseline CD4 count /=500 cells/microL had very good virological outcomes, being better than those with CD4 counts 200-499 cells/microL. CLINICAL TRIALS REGISTRATION: NCT01900977.