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SC31 Implementation of a same-day ART start model in a real-life setting: experiences from a clinical centre in Italy

sextrans · 2026-06-05 · canonical JSON source

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Background Many international guidelines, such as those by the World Health Organisation, endorse rapid ART initiation (RS) within 7 days of diagnosis, including same-day (SD) start, for all people with HIV (PWH) ready to initiate therapy.While convincing evidence exists for this approach in low-resource settings, data are conflicting in high-resource settings, especially concerning long-term retention in care. Moreover, direct comparisons between SD and RS strategies remain limited.Methods Newly diagnosed PWH starting ART within 7 days from the first linkage to the HIV clinical centre (Baseline) were included (January 2024-June 2025). Baseline standard laboratory tests were performed, whose results not available before ART initiation. Primary outcomes were a) viral suppression (VS; HIV RNA <50 copies/mL) at 6 months; b) need for ART change once laboratory results were available; c) retention-in-care at 6 and 12 months. Categorical variables and continuous variables were assessed by Fisher’s test and Wilcoxon rank sum as appropriate. Time to first documented VS was estimated by Kaplan–Meier curves, and Cox models adjusted for age, sex at birth, baseline HIV RNA, and CD4 cell count. A multivariable logistic regression was fitted to identify the major predictors of VS at 6 months.Results Characteristics of the cohort are reported in table 1. Of the 120 included PWH, 45 (37.5%) were in RS group vs. 75 (62.5%) in SD group. 4/120 were previously exposed to PrEP (3 in SD vs. 1 in RS). At baseline, 3/119 had HCV antibodies (all RS), and 2/118 had detectable HBsAg (1 in each group).No treatment modifications occurred once laboratory results were available. No IRIS episodes were documented.At 6 months, 85.7% in RS groups vs. 88.7% in SD reached VS (p=0.66), and all PWH but 3 (all in SD group) reached VS at 12 months (p=0.55). Among participants with a 6-month VL available (n=96), baseline CD4 count <200/mm3 and higher HIV RNA (log) at baseline were significantly associated with lower VS at 6 months (table 2).After adjusting for potential confounders, no significant differences emerged in time to VS (aHR 1.006, 95% CI: 0.68-1.49; p 0.98 for SD). The Kaplan Meier curve estimating the cumulative probability of achieving VS in the 2 groups is reported in figure 1 (log-rank test 0.84). No major differences between the two strategies were found in 6-month retention-in-care (p=1), although short follow-up precluded long-term evaluation.Conclusion In this real-life high-resource setting, SD ART initiation was feasible and safe, with no IRIS and no need for ART modification after baseline assessment. 6-month virologic outcomes and time-to-viral suppression were comparable between SD and the rapid-start strategy, with retention rates also comparable at 6 months.Abstract SC31 Table 1–2Abstract SC31 Figure 1Estimated probability of achieving HIV RNA <50 cp/mL during the follow-up period stratified by treatment start timing (Same-day start vs. other rapid start)