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Background
SARS-CoV-2 continues to spread globally and cause significant morbidity and mortality. Anti-spike protein monoclonal antibody (mAb) therapy has been shown to prevent progression to severe COVID-19 disease. The objective of this study was to report the outcomes of high-risk, SARS-CoV-2-positive patients infused with one of the three mAb available through FDA emergency use authorization (EUA).
Methods
A total of 4,328 SARS-CoV-2-positive patients that satisfied EUA criteria for eligibility for receiving mAb therapy were infused with bamlanivimab or combination therapies bamlanivimab-etesevimab or casirivimab-imdevimab from November 22, 2020, to May 31, 2021, at six infusion clinics and multiple emergency departments within the eight Houston Methodist Hospitals in Houston, Texas. The primary outcome of hospital admission within 14- and 28-days post-infusion was assessed relative to a propensity-score matched cohort, matched based on age, race/ethnicity, median income by zip code, body mass index, comorbidities, and positive PCR date. Secondary outcomes included ICU admission and mortality.
Results
A total of 2,879 infused patients and matched controls were included in the analysis, including 1,718 patients infused with bamlanivimab, 346 patients infused with bamlanivimab-etesevimab, and 815 patients infused with casirivimab-imdevimab. Hospital admission and mortality rates were significantly decreased overall in mAb-infused patients relative to matched controls. Among the infused cohort, those who received casirivimab-imdevimab had significantly decreased rate of admission relative to the other two mAbs groups (aRR = 0.51, p=0.001).
Conclusions
Treatment with bamlanivimab, bamlanivimab-etesevimab, or casirivimab-imdevimab significantly decreased the number of patients who progressed to severe COVID-19 disease and required hospitalization.
Background
Direct oral anticoagulants (DOACs) are widely utilized following cardiothoracic transplantation with limited guidance regarding drug–drug interactions (DDIs), periprocedural management, and DOAC‐specific monitoring.
Methods
We performed a single‐center, retrospective, descriptive analysis of adult cardiothoracic transplant recipients initiated on DOAC therapy between May 2016 and July 2021. The primary endpoint for this analysis was the percentage of patients dosed per package labeling. Secondary endpoints included DOAC prescribing in the context of DDIs, renal dysfunction, and periprocedural management, as well as thromboembolism and major bleeding at 12 months.
Results
A total of 125 patients were included in this analysis with a median age of 62 years. At initiation, 63.2% of patients were dosed according to package labeling. The most common reason for non‐labeled dosing was concomitant azole antifungal therapy. DOAC therapy was held for 82 procedures with no reported thrombotic events and one major bleed in the setting of AKI. Hemodialysis‐dependence was associated with a reduced risk of thrombosis (0 vs. 10 events per 100 PY, p = .002) and an increased risk of major bleeding (23 vs. 8 events per 100 PY, p = .006). Additionally, DOAC‐specific anti‐xa guided dosing was associated with a reduced risk of major bleeding (0 vs. 13 events per 100 PY, p < .001).
Conclusion
Our findings show that deviation from package labeling is common following cardiothoracic transplantation and its association with clinical outcomes warrants further study.
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