The aim of this study was to evaluate survival and treatment outcomes of AIDS presenters compared to the remaining portion of antiretroviral therapy (ART)-naive patients (pts) in a large Italian cohort.
All consecutive ART-naïve HIV+ pts, enrolled in Icona Foundation Study Cohort from January 2009 to December 2018, with HIV diagnosis within 3 months from enrolment, were included and divided into 3 groups: pts with an AIDS diagnosis at/within 3 months from HIV diagnosis [(1):AIDS presenters], asymptomatic pts with CD4 count at the enrolment ≤200 cell/mL [(2):asympt CD4≤200] or >200 cell/mL [(3):asympt CD4>200]. Survival probability was estimated by Kaplan Meier curves in both the overall period and separately, analyzing two 5-year periods (2009-2013; 2014-2018). Independent risk of survival and, in the subgroup of patients starting ART, virological failure (VF) (2 consecutive HIV-RNA >200 cp/ml after 6 months of ART) and treatment discontinuation (TD) for drug toxicity were identified by fitting a Cox regression model.
Overall, 7001 pts included: 959 AIDS presenters, 1,565 asympt CD4≤200 and 4,477 asympt CD4>200. ART was started in 6440 pts of whom 95%, 97% and 90% in group 1, 2 and 3 respectively. From 2009 to 2013, pts with advanced HIV presentation were significantly more likely to start PI/b-based regimen compared to asympt CD4>200 (63% and 68% vs 41%,p=0.001) whereas in the last five years INSTIs were the main third-drug started in all groups (60% for both group 1 and 2 and 52% for group3). At survival analysis, AIDS presenters showed the lowest probability of survival among the treatment groups [Fig1a]. 4-year survival estimates remained substantially stable over the two time periods [Fig1b,1c]. After adjusting for the main confounders, both the groups with advanced HIV presentation were associated to a higher risk of death compared to asympt CD4>200. This data was confirmed also restricting the analysis to those who started ART [Fig1d]. By multivariable analysis, AIDS presenters were associated with a greater risk of VF and of TD for toxicity compared to asympt CD4>200 [Fig1d].
Over the last decade, pts presenting with advanced HIV disease, particularly AIDS presenters, remained at consistently higher risk of death and poor response to ART. Public health strategies for emerging unknown infections and early treatment access are urgent to constrain the mortality gap of this vulnerable population.