CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

663

Disparities in Treatment Initiation by Race and Ethnicity Among Patients Hospitalized for COVID-19 Essy Mozaffari 1 , Aastha Chandak 2 , Alpesh N. Amin 3 , Robert L. Gottlieb 4 , Andre C. Kalil 5 , Mark Berry 1 , Gina Brown 1 , Jason F. Okulicz 1 , Chidinma Chima-Melton 6 1 Gilead Sciences, Inc, Foster City, CA, USA, 2 Certara, New York, NY, USA, 3 University of California Irvine, Irvine, CA, USA, 4 Baylor University Medical Center, Dallas, TX, USA, 5 University of Nebraska Medical Center, Omaha, NE, USA, 6 University of California Los Angeles, Los Angeles, CA, USA Background: The pandemic has shed light on the heightened risks of morbidity and mortality faced by minority patients hospitalized with COVID-19. However, there is a significant lack of real-world data that explores whether Black inpatients are less likely to receive appropriate pharmaceutical treatment for COVID-19 in the hospital than other racial groups. To address this evidence gap, we evaluated whether the initiation of evidence-based COVID-19 treatments upon hospital admission was related to race and ethnicity. Methods: Adults hospitalized with a primary diagnosis of COVID-19 between 5/2020- 4/2022 in the PINC AI Healthcare Database were examined. Baseline was defined as the first 2 days of hospitalization. Multivariable logistic regression models adjusting for key demographic, hospital, and clinical characteristics, were used to assess the association between race/ethnicity and initiation of COVID-19 treatments at baseline. Patients with no supplemental oxygen charges (NSOc), low-flow oxygen (LFO), high-flow oxygen/non-invasive ventilation (HFO/NIV) and invasive mechanical ventilation (IMV) at baseline were examined. Results: Of the 454,761 patients included in the study, 70% were White, 17% Black, 2% Asian, 11% other races, and 16% were Hispanic. Further, 86% patients received any COVID-19 treatment (84% corticosteroids, 52% remdesivir, and 4% received tocilizumab or baricitinib). Across all supplemental oxygen levels, White patients were significantly more likely to receive any COVID-19 treatment as well as corticosteroids, remdesivir, and baricitinib treatment as compared to Black patients (Figure). White patients on NSOc were more likely but those on LFO and HFO/NIV were significantly less likely to receive treatment with tocilizumab than Black patients (Figure). Treatment initiation for Non-Hispanic vs. Hispanic patients varied by baseline supplemental oxygen requirements. Conclusion: Black patients hospitalized for COVID-19 were significantly less likely to be treated with evidence-based COVID-19 treatments compared to other races across all levels of oxygen supplementation. As we enter the endemic phase, it is crucial that we highlight persistent disparities in patient management and strive towards standardized care for all patients during hospitalization for COVID-19, regardless of racial background or ethnicity.

symptom prevalence over time across the arms by fitting hierarchical mixed multivariate regressions. Results: 991 pts (SOT=332, T/C=327, N/r=332) enrolled from Mar 2022 to Feb 2023. Vaccinated people were 93%. Diabetes, lung, and cardiovascular diseases reported an imbalance between 5% and 10%. Among the 8/991 hospitalizations observed, one resulted in death. The overall estimate of failure was 0.81% (95%CI; 0.35-1.58%). Incidence across the arm varied from 0% (0.00-1.10) for N/r, to 0.60% (0.07-2.16) for SOT and 1.83% (0.68-3.95%) for T/C (p=0.015 by Fisher test for pooled data). The adjusted model showed evidence for an increased risk of failure in T/C arm compared with N/r arm (OR 8.41; 95%CI 1.21-inf. p=0.015) but not for other comparisons. No difference was detected in symptom prevalence over time between arms, with some symptoms persisting in more than 15% of pts on day 29. Conclusion: This RCT pooled analysis in the omicron era showed that N/r was superior to T/C in reducing hospital admission or death. Given the low number of events, the study produced no evidence on the other comparisons. No significant difference in symptom prevalence over time across the arms was found. The figure, table, or graphic for this abstract has been removed. Predictors of Failure to COVID-19 Early Therapies and Drugs Efficacy Comparison by Emulation Trial Valentina Mazzotta 1 , Alessandro Cozzi-Lepri 2 , Cosmo Del Borgo 3 , Silvia Rosati 1 , Martina Rueca 1 , Enrico Girardi 1 , L. Sarmati 4 , Claudio Maria Mastroianni 3 , Massimo Fantoni 5 , Fabrizio Maggi 1 , Emanuele Nicastri 1 , Miriam Lichtner 3 , Andrea Antinori 1 , for the Early Treatment for COVID- 19 Lazio Study Group 1 IRCCS Lazzaro Spallanzani, Rome, Italy, 2 University College London, London, United Kingdom, 3 Sapienza University of Rome, Rome, Italy, 4 University of Rome Tor Vergata, Rome, Italy, 5 Catholic University of the Sacred Heart, Milan, Italy Background: Although widespread vaccination and lower pathogenicity of the omicron variant had drastically reduced the rate of COVID-19-related hospitalization/death (CovH/D), real-world evidence can help to identify categories still at risk of severe outcomes and inform on the efficacy of different treatments used. Methods: Multicenter cohort of high-risk outpatients (pts) treated with monoclonal antibodies (mAbs) or antivirals for mild-to-moderate COVID-19 from March 2021 to May 2023 in the Latium Region. The outcome was CovH/D by day 30 from baseline by fitting logistic regression models, including a specific set of potential confounders, for each exposure of interest: age>75 years; vaccination; calendar period (reflecting the main circulating VoC), immunocompromised status. Among pts enrolled in 2022, the difference in risk between interventions (Sotrovimab=SOT; Molnupiravir=MLP; Remdesivr=RDV; tixagevimab/ cilgavimab=T/C; nirmatrelvir/rit=N/r) was estimated in emulated parallel trials using a marginal structural model. Results: 12,466 pts enrolled [female 50.2%, median age 70 yrs (IQR 57-80), unvaccinated 21%, immunocompromised 23.2%]. Primary endpoint occurred in 384/12,466 pts, with a day-30 incident risk of 3.08% (95% CI:2.7-3.4%). After controlling for potential confounders, a higher risk was observed for older aged (OR 2.01; 1.64-2.46), unvaccinated (2.30;1.73-3.05), and immunocompromised (1.41; 1.09-1.82). Using the "Delta period" as a reference, a decreased risk was observed in the Omicron waves. Among the 10,042 pts treated in 2022 (1,919 SOT, 3,733 MLP, 1,447 RDV, 433 T/C, 2510 N/r), failure rate according to intervention varied from 0.87% (0.55-1.32) for N/r, 1.68% (1.2-2.1) for MLP, 3.0% (1.6-5) for T/C, 3.5% (2.7-4.5) for SOT and 5.1% (4.1-6.4) for RDV. Emulation trial for comparison of different treatment options showed higher efficacy of oral antivirals in the prevention of CovH/D compared to mAbs or RDV; no significant differences were observed between the oral antivirals or between mAbs and RDV, respectively. Conclusion: Despite the decreasing risk of CovH/D across the calendar periods, older aged, unvaccinated, and immunocompromised patients remained at the highest risk of developing severe COVID-19. Oral antivirals showed higher efficacy in reducing Cov/H, while no significant differences were observed between them or between mAbs and RDV. These data could help to tailor therapies according to different risk factors and specific contraindications. The figure, table, or graphic for this abstract has been removed.

662

Poster Abstracts

664

Remdesivir Reduces Mortality in Immunocompromised Patients Hospitalised for COVID-19 During Omicron Essy Mozaffari 1 , Aastha Chandak 2 , Robert L. Gottlieb 3 , Chidinma Chima Melton 4 , Mark Berry 1 , Alpesh N. Amin 5 , Tobias Welte 6 , Paul E. Sax 7 , Andre C. Kalil 8 1 Gilead Sciences, Inc, Foster City, CA, USA, 2 Certara, LP, St Louis, MO, USA, 3 Baylor University Medical Center, Houston, TX, USA, 4 University of California Los Angeles, Los Angeles, CA, USA, 5 University of California Irvine, Irvine, CA, USA, 6 Medizinische Hochschule Hannover, Hannover, Germany, 7 Brigham and Women's Hospital, Boston, MA, USA, 8 University of Nebraska Medical Center, Omaha, NE, USA Background: Previous research has established the effectiveness of remdesivir (RDV) in reducing mortality among immunocompromised patients hospitalized for COVID-19. In this study, we present data from the Omicron predominant era (Dec'21-Apr'23) by examining in-hospital all-cause mortality for early RDV initiation vs. not initiating RDV among immunocompromised hospitalized COVID-19 patients. Methods: Using the PINC AI Healthcare database, adults with immunocompromised conditions (cancer, transplant, hematologic

CROI 2024 190