Publication date: Dec 25, 2024
This real-world study assessed the effectiveness of bebtelovimab (BEB) versus nirmatrelvir/ritonavir (NR) among outpatients with COVID-19 during the Omicron variant era. We conducted a cohort study evaluating patients treated with BEB or NR from February to August 2022 (study period). Follow-up began the day after treatment and continued for 30 days. Cohorts were constructed using de-identified electronic health record data from TriNetX Dataworks USA. The study assessed 30-day all-cause hospitalization or death (composite) using the risk difference (RD) and 95% confidence interval (95% CI). Unmatched cohorts included 12,920 BEB- and 70,741 NR-treated patients. After exact matching on key baseline covariates (age > 65 years, immunocompromised, recent emergency department [ED] visit, and COVID-19 vaccination) and high-dimensional propensity score matching (1:1) on a broader set of covariates, 5827 patients were included in each cohort. BEB-treated patients were older and had more comorbidities compared to NR-treated patients prior to matching. After matching, baseline characteristics were well balanced. The cumulative incidence of the primary outcome (hospitalization or death) was 2. 0% and 1. 8% for BEB and NR, respectively (RD 0. 2%; 95% CI – 0. 3%, 0. 7%). The upper bound of the RD 95% CI (0. 7%) excluded the noninferiority margin (1. 795%), demonstrating that BEB was not inferior to NR. The RDs of the secondary outcomes were (BEB vs NR): hospitalization (RD 0. 1%; 95% CI – 0. 4%, 0. 6%); ED visit (RD 0. 5%; 95% CI – 0. 3%, 1. 3%); and death (RD 0. 09%; 95% CI – 0. 003%, 0. 2%). Results from subgroup, sensitivity, and linked analyses (EHR + claims + mortality data) were consistent with the main results. Treatment with BEB was not inferior to NR with respect to 30-day all-cause hospitalization or death. The risk of secondary outcomes was not different for patients treated with BEB compared to NR.
Concepts | Keywords |
---|---|
30days | Bebtelovimab |
Covid | COVID-19 |
Death | Nirmatrelvir |
Immunocompromised | Observational study |
Primary | Omicron variant |
Paxlovid | |
Ritonavir |
Semantics
Type | Source | Name |
---|---|---|
drug | DRUGBANK | Ritonavir |
disease | MESH | COVID-19 |
disease | MESH | death |
disease | MESH | emergency |