UCSF

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.