CROI 2020 Abstract eBook

Abstract eBook

Poster Abstracts

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.

Poster Abstracts

480 EMULATION OF AN RCT OF DOLUTEGRAVIR VS BOOSTED-DARUNAVIR IN ADVANCED ART NAIVE Andrea Antinori 1 , Franco Maggiolo 2 , Nicola Gianotti 3 , Stephen R. Cole 4 , Jessie K. Edwards 4 , Sergio Lo Caputo 5 , Andrea Calcagno 6 , Cristina Mussini 7 , Pierluigi Blanc 8 , Daniela Francisci 9 , Antonella D'Arminio Monforte 10 , Alessandro Cozzi- Lepri 11 1 Lazzaro Spallanzani National Institute for Infectious Diseases, Rome, Italy, 2 Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy, 3 San Raffaele Scientific Institute, Milan, Italy, 4 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 5 University of Bari, Bari, Italy, 6 University of Torino, Torino, Italy, 7 University of Modena and Reggio Emilia, Modena, Italy, 8 Santa Maria Annunziata Hospital, Florence, Italy, 9 University of Perugia, Perugia, Italy, 10 Azienda Ospedaliera San Paolo, Milan, Italy, 11 University College London, London, UK Background: Second generation INSTIs currently represent the most highly recommended option for first-line ART but superiority to boosted-PI regimens in people with advanced HIV disease (CD4 count <200 cells/mm 3 or AIDS), generally underrepresented or excluded from RCTs, has not been demonstrated. Methods: We included ART-naïve patients with CD4 count <200 cells/ mm 3 or AIDS diagnosis in the Icona Foundation Cohort between 2014-2018, who started a dolutegravir [DTG] or boosted-darunavir [DRV/b (ritonavir or cobicistat)] based ART. We estimated the effect of the difference in risk of a composite endpoint (death, AIDS, serious non-AIDS events - SNAE - viral failure >200 copies/mL, anchor drug discontinuation not followed by a restart of a drug in the same class) between the two strategies using a marginal structural model. We accounted for differences in prognostic factors measured at time of ART initiation. We also accounted for differences in censoring by these same prognostic factors, and time-varying CD4, HIV-RNA and ALT. Results: Characteristics of the 685 ART-naïve patients were (DTG=416; DRV/ b=269; 224 DRV/r and 45 DRV/cobi): male 87%; heterosexual contacts 50%, MSM 37%; born outside Italy 48%; AIDS presenting 36%; median CD4 count 78 cell/mm 3 (IQR 30-140); median HIV-RNA 5.25 log 10 copies/mL (IQR 4.64, 5.73). All these variables were comparable between the two groups, except for higher proportion of migrant in DTG (51% vs 43%; p <0.001) and higher HIV-RNA values in DRV/b (5.35 vs 5.18 log 10 /mL; p=0.019). NRTI backbone was TDF/FTC in 58% (80% in DRV/b and 44% in DTG), TAF/FTC in 11% (10% in DRV/b and 12% in DTG), and ABC/3TC in 30% (10% in DRV/b and 44% in DTG) (p <0.001). 116 patients receiving DTG and 145 receiving DRV/b experienced the composite endpoint. The 1-year weighted probability of the composite endpoint was 37% for DRV/b and 21% for DTG (Figure 1a). Patients who initiated DTG were at lower risk of experiencing the composite endpoint compared to those who started DRV/b [aHR 0.50 (95%CI 0.32, 0.79)] (Figure 1b). Calendar year of starting was a key factor but results were consistent across periods of ART initiation. Conclusion: Under the assumptions of no unmeasured confounding and correct model specification, our analysis suggests that a RCT conducted in the

479 PERSISTENT POOR CLINICAL OUTCOMES FOR AIDS PRESENTATION IN ITALY OVER THE LAST DECADE Annalisa Mondi 1 , Patrizia Lorenzini 1 , Alessandro Cozzi-Lepri 2 , Antonella Cingolani 3 , Mariana Farenga 4 , Stefano Rusconi 5 , Gabriella De Girolamo 6 , Andrea Gori 5 , Marta Camici 1 , Cristina Mussini 7 , Antonella D'Arminio Monforte 5 , Andrea Antinori 1 , for the Icona Foundation Study Group 1 Lazzaro Spallanzani National Institute for Infectious Diseases, Rome, Italy, 2 University College London, London, UK, 3 Catholic University of the Sacred Heart, Rome, Italy, 4 Amedeo di Savoia Hospital, Torino, Italy, 5 University of Milan, Milan, Italy, 6 Sapienza University of Rome, Rome, Italy, 7 University of Modena and Reggio Emilia, Modena, Italy Background: 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. Methods: 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. Results: 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]. Conclusion: Over the last decade, pts presenting with advanced HIV disease, particularly AIDS presenters, remained at consistently higher risk of death and

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