Objectives
To describe real-world outcomes for COVID-19 patients receiving an Early Use Authorization (EUA) treatment (monoclonal antibody [mAb], prophylaxis mAb, antiviral).
Methods
Administrative claims data from Komodo Health were used to identify US patients (aged ≥12 years) diagnosed with COVID-19 in an ambulatory setting (26 May 2021 and 05 April 2022) and assign to cohorts: (1) Early Treatment: received mAb or antivral for early treatment of COVID-19; (2) Prophylaxis Treatment: received mAb for prophylactic treatment of COVID-19; (3) No Treatment. Index date was defined as the date of treatment or COVID-19 diagnosis date (for the untreated cohort). Patients were continuously enrolled for ≥12 months pre-index and ≥29 days post-index and flagged if meeting the EUA high-risk criteria based on ICD-10 codes and medications received 12-months pre-index. Hospitalization rates and mortality (all-cause for both) within 29 days of index date were described.
Results
Of 434,766 patients in the Early Treatment cohort, 80% were high risk, 95% received mAbs (80% high risk), and 5% (86% high risk) received antiviral. The Prophylaxis Cohort comprised 2,015 patients (96% high risk), and the untreated cohort 4,231,748 patients (61% high risk). Differences in baseline characteristics were noted between treated and untreated patients: untreated patients were younger (41 versus 49 years), had a higher proportion of Medicare/Medicaid coverage (32% versus 22%), and lower mean Quan-Charlson score (0.6 versus 0.8). The 29-day hospitalization and/or mortality rate was 3.2% (n=13,707) in Early Treatment (mAb, 3.1%; antiviral, 3.6%), 4.0% (n=80) in Prophylaxis, and 3.6% (n=152,427) in untreated patients (which increased to 4.9% [128,093 of 2,592,568] among high-risk untreated patients).
Conclusions
Low rates of adverse clinical outcomes (hospitalization/mortality) were observed during the study period, which included the Delta and early Omicron COVID-19 variants. Differences in patient characteristics warrant careful consideration of designs for future studies. Funding: GSK (Study 218263)