%0 Journal Article
%T Efficacy and safety of antiviral plus anti-spike monoclonal antibody combination therapy vs. monotherapy for high-risk immunocompromised patients with mild-to-moderate SARS-CoV2 infection during the Omicron era: A prospective cohort study.
%A Calderón-Parra J
%A Gutiérrez-Villanueva A
%A Ronda-Roca G
%A Jimenez MLM
%A de la Torre H
%A Ródenas-Baquero M
%A Paniura-Pinedo M
%A Lozano-Llano C
%A Pintos-Pascual I
%A Fernández-Cruz A
%A Ramos-Martínez A
%A Muñez-Rubio E
%J Int J Antimicrob Agents
%V 63
%N 3
%D 2024 Mar 18
%M 38244814
%F 15.441
%R 10.1016/j.ijantimicag.2024.107095
%X <B>BACKGROUND: </B>Antivirals and monoclonal antibodies lower the risk of progression in immunocompromised patients. However, combination therapy with both types of agents has not been studied.<BR><B>METHODS: </B>This was a single-centre, prospective, cohort study. All immunocompromised patients who received treatment for mild-to-moderate COVID-19 from 1 January 2022 to 30 October 2022 were enrolled. The primary endpoint was COVID-19 progression at 90 days, defined as hospital admission or death due to COVID-19 and/or seronegative persistent COVID-19.<BR><B>RESULTS: </B>A total of 304 patients were included: 43 patients (14.1%) received sotrovimab plus a direct-acting antiviral, and 261 (85.9%) received monotherapy. Primary outcome occurred more frequently after monotherapy (4.6% vs. 0%, P=0.154). Among patients with anti-spike immunoglobulin G (anti-S IgG) titre <750 BAU/mL, COVID-19 progression was more common after monotherapy (23.9% vs. 0%, P=0.001), including more frequent COVID-related admission (15.2% vs. 0%, P=0.014) and seronegative persistent COVID-19 (10.9% vs. 0%, P=0.044). Combination therapy was associated with lower risk of progression (odds ratio [OR] 0.08, 95% confidence interval [95% CI] 0.01-0.64). Anti-S IgG titre <750 BAU/mL and previous anti-CD20 were associated with higher risk of progression (OR 13.70, 95% CI 2.77-67.68; and OR 3.05, 95% CI 1.20-10.94, respectively).<BR><B>CONCLUSIONS: </B>In immunocompromised patients, combination therapy with sotrovimab plus an antiviral may be more effective than monotherapy for SARS-CoV2.