Successful antiretroviral therapy delivery and retention in care among asymptomatic individuals with high CD4+ T-cell counts above 350 cells/μl in rural Uganda

Background:HIV antiretroviral therapy (ART) is being rapidly scaled up in sub-Saharan Africa, including recently patients with CD4(+) T-cell counts above 350cells/l. 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 350cells/l 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 350cells/l, 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 (400copies/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 350cells/l, median CD4(+) cell count was 569cells/l (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/l 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.