Background: HIV antiretroviral therapy (ART) is being rapidly scaled up in sub-Saharan Africa, including recently patients with CD4 T-cell counts above 350 cells/μl. However, concerns persist about adherence and virologic suppression among these asymptomatic, high CD4 cell count individuals.
Objective: To determine the virologic efficacy and safety of ART among asymptomatic HIV-positive Ugandan adults with high CD4 cell counts above 350 cells/μl via a streamlined model of care.
Design: Prospective nonrandomized clinical study (EARLI Study: clinicaltrials.gov NCT#01479634).
Setting: Prototypic rural Ugandan HIV clinic.
Patients/participants: Asymptomatic, ART-naive adults (aged >18 years, N = 197) with CD4 at least 350 cells/μl, without pregnancy or WHO stage 3/4 illness.
Interventions: ART included tenofovir/emtricitabine/efavirenz, with ritonavir/lopinavir substitution for efavirenz available. Streamlined ART model included nurse-driven visits with physician back-up, basic safety laboratory monitoring with HIV viral load, clinician telephone contact, and defaulter tracking. No incentives were provided.
Outcomes: Undetectable viral load (≤400 copies/ml) at 24 and 48 weeks [intention to treat (ITT); missing = detectable), self-reported ART adherence, retention in care, and laboratory/clinical ART toxicities.
Results: Of the 197 patients with CD4 above 350 cells/μl, median CD4 cell count was 569 cells/μl (interquartile range 451-716). Undetectable viral load was achieved in 189 of 197 (95.9%, ITT) and 189 of 195 (96.9%, ITT) of participants at weeks 24 and 48, respectively. Self-reported adherence was 98% and 192 of 197 (97%) of the patients were retained at week 48. Laboratory adverse events and hospitalizations were rare.
Conclusions: We demonstrate high virologic suppression, retention, and safety among asymptomatic individuals with CD4 above 350 cells/μl in a prototypic Ugandan clinic. Our results challenge current concerns that individuals with high CD4 cell count lack motivation for ART, and may not achieve sustained virologic suppression.
Trial registration: ClinicalTrials.gov NCT01479634.