Epidemiology and Biostatistics

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Browsing Epidemiology and Biostatistics by Subject "Baseline CD4 cell count"

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    Better virological outcomes among people living with human immunodeficiency virus (HIV) initiating early antiretroviral Tteatment (CD4 Counts ≥500 Cells/µL) in the HIV Prevention Trials Network 071 (PopART) trial in South Africa
    (Oxford University Press, 2020-01-16) Fatti, Geoffrey; Grimwood, Ashraf; Nachega, Jean B.; Nelson, Jenna A.; LaSorda, Kelsea; van Zyl, Gert; Grobbelaar, Nelis; Ayles, Helen; Hayes, Richard; Beyers, Nulda; Fidler, Sarah; Bock, Peter
    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.