Initiating patients on antiretroviral therapy at CD4 cell counts above 200 cells/µl is associated with improved treatment outcomes in South Africa

Observational cohort study. Methods Patients presenting to primary care clinics with CD4 cell counts <350 cells/mm3 were randomized to either doctor- or nurse-managed HIV care and followed for at least two years after ART initiation. Clinical and laboratory outcomes were compared by baseline CD4 count. Results 812 patients were followed for a median of 27.5 months and 36% initiated with a CD4 count >200. While 10% of patients failed virologically (VF), the risk was nearly double among those with a CD4 ≤200 vs. >200 (12.2% vs. 6.8%). 21 deaths occurred, with a five-fold increased risk for the low CD4 group (3.7% vs. 0.7%). After adjustment, those with a CD4 count ≤200 had twice the risk of death/VF (HR 1.9; 95% CI: 1.1–3.3) and twice the risk of incident tuberculosis (HR: 1.90; 95% CI: 0.89–4.04) as those >200. Those with either a CD4 ≤200 (HR 2.1; 1.2–3.8) or a WHO IV condition (HR 2.9; 0.93–8.8) alone had a two to three-fold increased risk of death/VF vs. those with neither, but those with both conditions had a 4-fold increased risk (HR 3.9; 95% CI: 1.9–8.1). We observed some increased loss to follow-up among those initiating