Abstract 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 (<400 copies/mL), confirmed virological failure (VF) (2 consecutive viral loads >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/µL 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/µL (3.3%) compared to those with CD4 count 200–499 cells/µL (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 <200, 200–499, and ≥500 cells/µL, respectively ( P < .0001). VF was independently lower among participants with baseline CD4 count ≥500 cells/µL (adjusted hazard ratio [aHR], 0.23; P = .045) and 3-fold higher among those with baseline CD4 count <200 cells/µL (aHR, 3.49; P < .0001). Conclusions Despite previous concerns, participants initiating ART with CD4 counts ≥500 cells/µL had very good virological outcomes, being better than those with CD4 counts 200–499 cells/µL. Clinical Trials Registration NCT01900977. There are concerns that people initiating antiretroviral therapy (ART) with high CD4 counts may exhibit reduced HIV virological suppression. In this study, however, participants with CD4 count ≥500 cells/µL had excellent virological outcomes, better than those with lower CD4 counts.
【저자키워드】 HIV/AIDS, early antiretroviral treatment, virological outcomes, baseline CD4 cell count, HPTN 071 (PopART) Trial, 【초록키워드】 HIV, Trial, risk, prevention, prospective cohort study, CD4, Relative risk, Registration, South Africa, Viral, Viral load, clinical, International, implementation, Antiretroviral therapy, virological outcomes, ART, incidence rate, network, Human immunodeficiency virus, confidence interval, Participants, adjusted hazard ratio, immunodeficiency virus, hazard ratio, adjusted relative risk, participant, CD4 counts, National, baseline CD4, virological suppression, universal ART, virological failure, Result, clinically, elevated, provided, reduced, interval, baseline CD4 cell, CD4 count, pre-ART CD4, pre-ART CD4 cell, virological outcome, 【제목키워드】 HIV, Human, prevention, CD4, network, count, Better, Initiating,