Abstract:
Background. Severely immunocompromised human immunodeficiency virus (HIV)–infected individuals have high mortality
shortly after starting antiretroviral therapy (ART). We investigated predictors of early mortality and “late presenter” phenotypes.
Methods. The Reduction of EArly MortaLITY (REALITY) trial enrolled ART-naive adults and children ≥5 years of age with
CD4 counts <100 cells/μL initiating ART in Uganda, Zimbabwe, Malawi, and Kenya. Baseline predictors of mortality through 48
weeks were identified using Cox regression with backwards elimination (exit P > .1).
Results. Among 1711 included participants, 203 (12%) died. Mortality was independently higher with older age; lower CD4
count, albumin, hemoglobin, and grip strength; presence of World Health Organization stage 3/4 weight loss, fever, or vomiting; and
problems with mobility or self-care at baseline (all P < .04). Receiving enhanced antimicrobial prophylaxis independently reduced
mortality (P = .02). Of five late-presenter phenotypes, Group 1 (n = 355) had highest mortality (25%; median CD4 count, 28 cells/
μL), with high symptom burden, weight loss, poor mobility, and low albumin and hemoglobin. Group 2 (n = 394; 11% mortality;
43 cells/μL) also had weight loss, with high white cell, platelet, and neutrophil counts suggesting underlying inflammation/infec-
tion. Group 3 (n = 218; 10% mortality) had low CD4 counts (27 cells/μL), but low symptom burden and maintained fat mass. The
remaining groups had 4%–6% mortality.
Conclusions. Clinical and laboratory features identified groups with highest mortality following ART initiation. A screening
tool could identify patients with low CD4 counts for prioritizing same-day ART initiation, enhanced prophylaxis, and intensive
follow-up.
