ABSTRACT
Background: Pre-exposure prophylaxis for COVID-19 with tixagevimab/cilgavimab (T/C) received Emergency Use Authorization (EUA) based off of results from a clinical trial conducted prior to the Omicron variant. Its clinical effectiveness has not been well described in the Omicron era. We examined the incidence of symptomatic illness and hospitalizations among T/C recipients when Omicron accounted for virtually all cases. Methods: We used the electronic medical record to identify patients who received T/C at our institution. Among these patients, we assessed for cases of symptomatic COVID-19 and associated hospitalizations before and after receiving T/C. We used chi square tests and Fishers exact p-values to examine differences between characteristics of those who got COVID before and after T/C prophylaxis. Results: Of 1295 T/C recipients, 121 (9.3%) developed symptomatic COVID-19 before receiving T/C, and 102 (7.9%) developed symptomatic disease after receiving it. Among those with infection prior to T/C, 36/121 (29.8%) were hospitalized, including 8 (6.6%) admitted to the ICU. Among those with COVID-19 after receiving T/C, 6/102 (5.9%) were hospitalized but none required ICU admission. No COVID-related deaths occurred in either group. The majority of COVID-19 cases among those infected prior to T/C treatment occurred during Omicron BA.1 surge, while the majority of cases among post-T/C recipients occurred when BA.5 was predominant. Patients infected with COVID-19 prior to receiving T/C had received fewer vaccine doses and were less likely to receive COVID-19 therapeutics compared to those with COVID-19 after having received T/C. Conclusion: We identified COVID-19 infections after T/C prophylaxis. Among persons eligible for T/C, COVID-19 illnesses occurring after T/C were less likely to require hospitalization compared to those with COVID-19 prior to T/C. In the presence of changing vaccine coverage, multiple therapies, and changing variants, the effectiveness of T/C in the Omicron era remains difficult to assess.
Subject(s)
Critical Illness , COVID-19ABSTRACT
Objectives: Main objective was to systematically determine most frequently used medications among COVID-19 patients overall and by hospitalization status. Secondary objective was to measure use patterns of medications considered potential therapeutic options Design: Retrospective cohort study. Setting: The five academic medical centers of University of California Health. Participants: University of California COVID Research Data Set (UC CORDS) patients between March 10, 2020 and December 31, 2020. Exposure(s): Confirmed COVID-19 positive by SARS-CoV-2 nucleic acid amplification. Main Outcome(s) and Measure(s): Main outcomes were percentages of patients prescribed medications, overall, by age group, and by comorbidity based on hospitalization status. Use percentage by month of COVID-19 diagnosis was measured. Cumulative count of potential therapeutic options was measured over time. Results: Dataset included 22897 unique patients with COVID-19 (mean [SD] age, 42.4 [20.4] years; 12154 [53%] female). Among the sample, 6326 28%) were non-Hispanic White, 8475 (37%) were Hispanic, 1562 (7%) Asian, and 1313 (6%) Black. A COVID-related hospitalization occurred in 3546 patients. Of the hospitalized patients, more than 30% had baseline comorbidities of hypertension (48%), hyperlipidemia (37%), and type 2 diabetes (35%). Most frequently used medications in patients overall were acetaminophen (21.2%), albuterol (14.9%), ondansetron (13.9%), and enoxaparin (10.8%). Medications used were generally similar across ages and comorbidities. Prior to May, dexamethasone was rarely used, with well under 50 COVID-19 patients that had been hospitalized to that point receiving the medication. By mid-August, more than 500 patients to that point had received dexamethasone. Hydroxychloroquine use effectively halted in COVID-19 hospitalized patients after May. Throughout the period of March to December 2020, enoxaparin was used in the most patients to that point at any instance. By mid-December, more than 2000 in the analysis cohort of hospitalized patients had received enoxaparin. Conclusions and Relevance: In this retrospective cohort study, across age and comorbidity groups, predominant utilization was for supportive care therapy. Dexamethasone and remdesivir experienced large increases in use. Conversely, hydroxychloroquine and azithromycin use markedly dropped. Medication utilization rapidly shifted towards more evidence-concordant treatment of patients with COVID-19 as rigorous study findings emerged.