HPTN Bibliographic Record

Fatti G, Grimwood A, Nachega JB, Nelson JA, LaSorda K, Zyl GV, Grobbelaar N, Ayles H, Hayes R, Beyers N, Fidler S, Bock P, for the HPTN 071 Study Team. Better Virological Outcomes amongst People Living with HIV Initiating Early Antiretroviral Treatment (CD4 counts >/= 500 cells/microL) in the HPTN 071 (PopART) Trial in South Africa. Clin Infect Dis.
BACKGROUND: There have been concerns about reduced adherence and HIV virological suppression (VS) amongst clinically well people living with HIV initiating antiretroviral treatment (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 HPTN 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 ART irrespective of CD4 count since January 2014. VS (<400 copies/ml), confirmed virological failure (VF) (two consecutive viral loads>1000 copies/ml) and viral rebound were compared between participants in strata of baseline CD4 count. RESULTS: The sample included 1901 participants. VS was 94% or greater amongst participants with baseline CD4 count >/=500 cells/microL at all six-monthly intervals to 30 months of ART. The risk of an elevated viral load (>/=400 copies/ml) was independently lower amongst participants with baseline CD4 count >/=500 cells/microL (3.3%) compared to those with CD4 count 200-499 cell/microL (9.2%) between months 18-30, adjusted relative risk=0.30 (95% CI: 0.12-0.74, P=0.010). The incidence rate of VF was 7.0, 2.0 and 0.5 per 100 person-years amongst participants with baseline CD4 count <200, 200-499 and >/=500 cells/microL, respectively (P<0.0001). VF was independently lower amongst participants with baseline CD4 count >/=500 cells/microL, adjusted hazard ratio (aHR)=0.23, P=0.045; and three-fold higher amongst those with baseline CD4 count <200 cells/microL, aHR=3.49, P<0.0001. CONCLUSION: Despite previous concerns, participants initiating ART with CD4 counts >/=500 cells/microL had very good virological outcomes, being better than those with CD4 counts 200-499 cells/microL.