Clinical presentation and effectiveness of antiretroviral therapy in newly diagnosed people living with HIV before, during and after the COVID-19 pandemic.

Background: In Italy, the COVID-19 pandemic substantially disrupted access to health care services, including HIV screening, contributing to a decline in new HIV diagnoses and increasing late presentations in the postpandemic years. This study assessed the profile and trends of newly diagnosed people living with HIV (ndPLWH) across the prepandemic, peripandemic and postpandemic periods in two major Italian centres. Methods: We conducted a retrospective observational study including adults diagnosed with HIV-1 infection between 2015 and 2023 at two HIV outpatient clinics in Central (Centre A) and Northern Italy (Centre B). According to the year of diagnosis, ndPLWH were categorised into four periods spanning from prepandemic to postpandemic years. We compared the number and clinical characteristics of ndPLWH and assessed virological suppression (VS; HIV-RNA <50 copies/mL) at 6 months after ART initiation. Predictors of VS were identified using logistic regression models. Results: A total of 1042 ndPLWH were evaluated, including 423 (40.6%) from Centre A and 619 (59.4%) from Centre B. AIDS-defining conditions peaked during the pandemic period (31.6%, 61/193; p=0.031). The time from diagnosis to antiretroviral therapy (ART) initiation shortened substantially from the prepandemic period to the postpandemic period (p<0.001), and the use of integrase strand transfer inhibitor (INSTI)-based regimens increased significantly across these periods (p<0.001). NdPLWH from Central Italy presented with a generally worse clinical profile, but the median time from HIV diagnosis to ART initiation was significantly shorter in this group (p<0.001). At 6 months, 84.5% of the patients achieved VS, with no interperiod variation (p=0.519); a higher CD4 count (adjusted OR (aOR) 1.143; 95% CI 1.052 to 1.243; p=0.002) and INSTI-based triple therapy (aOR 2.191; 95% CI 1.455 to 3.299; p<0.001) remained independently associated with VS. Conclusions: Despite substantial disruptions in HIV care during the COVID-19 pandemic and an increased proportion of late presenters, virological suppression rates remained high and stable throughout all the study periods, with no differences between the centres. These findings highlight the resilience of HIV care systems in Italy and the importance of maintaining tireless testing pathways amid health care challenges.