Abstract:
Background—Few studies have reported CD4%- and age-stratified rates of WHO Stage 3
(WHO3) events, WHO Stage 4 (WHO4) events, tuberculosis (TB), and mortality in HIV-infected
infants before initiation of antiretroviral therapy (ART).
Methods—HIV-infected children enrolled before 1 year of age in the International
Epidemiologic Databases to Evaluate AIDS (IeDEA) East Africa region (10/01/2002-11/30/2008)
were included. We estimated incidence rates of earliest clinical event (WHO3, WHO4, and TB),
prior to ART initiation per local guidelines, stratified by current age (< or ≥6 months) and currentCD4% (<15%, 15–24%, ≥25%). CD4%-stratified mortality rates were estimated separately for
children who did not experience a clinical event (“background” mortality) and for children who
experienced an event, including “acute” mortality (≤30 days post-event) and “later” mortality (>30
days post-event).
Results—Among 847 children (median enrollment age: 4.8 months; median pre-ART follow-up:
10.8 months; 603 (71%) with ≥1 CD4% recorded), event rates were comparable for those aged <6
and ≥6 months. Current CD4% was associated with risk of WHO4 events for children <6 months
old, and with all evaluated events for children ≥6 months old (p<0.05). “Background” mortality
was 3.7–8.4/100py. “Acute” mortality (≤30 days post-event) was 33.8/100py (after TB) and
41.1/100py (after WHO3 or WHO4). “Later” mortality (>30 days post-event) ranged by CD4%
from 4.7–29.1/100py.
Conclusions—In treatment-naïve, HIV-infected infants, WHO3, WHO4, and TB events were
common before and after 6 months of age and led to substantial increases in mortality. Early infant
HIV diagnosis and treatment are critically important, regardless of CD4%.
