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1.
Mayo Clinic Proceedings: Innovations, Quality & Outcomes ; 2023.
Article in English | ScienceDirect | ID: covidwho-2181434

ABSTRACT

Objective To test the hypothesis that the MASS Score performs consistently better in identifying need for monoclonal-antibody infusion throughout each "wave” of SARS-CoV-2 variant predominance during the COVID-19 pandemic and the infusion of contemporary monoclonal-antibody treatments is associated with a lower risk of hospitalization. Patients and Methods In this retrospective cohort study, we evaluated the efficacy of monoclonal-antibody treatment as compared to no monoclonal-antibody treatment in symptomatic adults who tested positive for SARS-CoV-2, regardless of their risk factors for disease progression or vaccination status during different periods of SARS-CoV-2 variant predominance. The primary outcome was hospitalization within 28 days after COVID-19 diagnosis. The study was conducted on patients diagnosed with COVID-19 from November 19, 2020, through May 12, 2022. Results Of the included 118,936 eligible patients, hospitalization within 28 days of COVID-19 diagnosis occurred in 2.52% (456/18,090) of patients who received monoclonal-antibody treatment and 6.98% (7,037/100,846) of patients who did not. Treatment with monoclonal-antibody therapies was associated with a lower risk of hospitalization when using stratified data analytics, propensity scoring, and regression and machine learning models with and without adjustments for putative confounding variables, such as advanced age and coexisting medical conditions (e.g., relative risk: 0.15;95% CI, 0.14 to 0.17). Conclusions Among patients with mild to moderate COVID-19, including those who have been vaccinated, monoclonal-antibody treatment was associated with a lower risk of hospital admission during each wave of the COVID-19 pandemic.

2.
Curr Opin Organ Transplant ; 27(4): 269-276, 2022 Aug 01.
Article in English | MEDLINE | ID: covidwho-2118071

ABSTRACT

PURPOSE OF REVIEW: Coronavirus disease-2019 (COVID-19) disproportionately causes severe outcomes in solid organ transplant recipients (SOTR). Antispike monoclonal antibodies have been authorized for therapy and prophylaxis for COVID-19. Here, we review the current state of antispike monoclonal antibodies and their role for SOTRs. RECENT FINDINGS: Bamlanivimab with or without etesevimab, casirivimab-imdevimab and sotrovimab have reduced the rates of hospitalization and severe disease in high-risk patients with mild-to-moderate COVID-19. Multiple retrospective studies have also demonstrated monoclonal antibodies are effective in SOTR populations. However, the evolution of resistant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concerns has resulted in revocation of the authorization of bamlanivimab with or without etesevimab, and casirivimab-imdevimab as treatment and postexposure prophylaxis (PEP). Sotrovimab and bebtelovimab are currently authorized for treatment of the predominant circulating SARS-CoV-2 B.1.1.529 (Omicron), but not as pre or PEP. Tixagevimab-cilgavimab, a long-acting antibody combination preparation, is authorized for preexposure prophylaxis in high-risk immunocompromised populations, including SOTRs, who are less likely to mount an effective immune response following vaccination series and booster. SUMMARY: Antispike monoclonal antibodies are useful for the prevention and treatment of mild-to-moderate COVID-19 in SOTRs. However, their clinical use should be determined by the evolving epidemiology of SARS-CoV-2 variants in the community.


Subject(s)
COVID-19 , Organ Transplantation , Humans , SARS-CoV-2 , COVID-19/prevention & control , Retrospective Studies , Antibodies, Monoclonal/adverse effects , Organ Transplantation/adverse effects , Transplant Recipients
3.
J Infect Dis ; 226(10): 1683-1687, 2022 Nov 11.
Article in English | MEDLINE | ID: covidwho-2117632

ABSTRACT

The effectiveness of bebtelovimab in real-world settings has not been assessed. In this retrospective cohort study of 3607 high-risk patients, bebtelovimab was used more commonly than nirmatrelvir-ritonavir for treatment of coronavirus disease 2019 (COVID-19) among older patients, immunosuppressed patients, and those with multiple comorbid conditions. Despite its use in patients with multiple comorbid conditions, the rate of progression to severe disease after bebtelovimab (1.4% [95% confidence interval, 1.2%-1.7%]) was not significantly different from that for nirmatrelvir-ritonavir treatment (1.2% [.8%-1.5%]). Our findings support the emergency use authorization of bebtelovimab for treatment of COVID-19 during the Omicron epoch dominated by BA.2 and subvariants.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , COVID-19/drug therapy , Ritonavir/therapeutic use , Retrospective Studies
4.
Open Forum Infect Dis ; 9(10): ofac411, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-2062946

ABSTRACT

Background: Antispike monoclonal antibodies are recommended for early treatment of high-risk persons with mild to moderate coronavirus disease 2019 (COVID-19). However, clinical outcomes of their use during the severe acute respiratory syndrome coronavirus 2 Omicron wave are limited. Methods: This is a descriptive retrospective study of high-risk adult patients who received treatment with sotrovimab (January 1-March 20, 2022) or bebtelovimab (March 21-April 30, 2022). The primary outcome was the proportion of patients who progressed to severe outcome within 30 days after receiving antispike-neutralizing monoclonal antibody infusion. Results: A total of 3872 high-risk patients (median age, 62.7 years; 41.1% male) with mild to moderate COVID-19 received sotrovimab (n = 2182) or bebtelovimab (n = 1690). Among sotrovimab-treated patients, the most common comorbidities were an immunosuppressed condition (46.7%), hypertension (38.2%), and diabetes (21.2%). The rates of severe outcome, intensive care unit (ICU) admission, and mortality were 2.2%, 1.0%, and 0.4%, respectively, after sotrovimab infusion. Among bebtelovimab-treated patients, the most common comorbidities were hypertension (42.7%), diabetes (17.1%), and an immunosuppressed condition (17.0%). The rates of severe disease, ICU admission, and mortality were 1.3%, 0.5%, and 0.2%, respectively, after bebtelovimab infusion. Older age, immunosuppressed status, and several comorbidities were associated with severe disease progression, while COVID-19 vaccination was associated with lower risk. No anaphylaxis was reported during monoclonal antibody infusion. Conclusions: This real-world analysis of a large cohort of high-risk patients demonstrates low rates of severe disease after treatment with sotrovimab during the era dominated by Omicron B.1.1.529 and after treatment with bebtelovimab during the era dominated by BA.2 and Omicron subvariants.

6.
Transpl Infect Dis ; 24(4): e13901, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-2008758

ABSTRACT

BACKGROUND: Solid organ transplant recipients (SOTRs) are at high-risk for severe infection from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Anti-spike monoclonal antibodies are currently utilized under emergency use authorization to prevent hospitalization in high-risk individuals with coronavirus disease 2019 (COVID-19), including SOTRs. However, clinical data for bebtelovimab, the sole currently available anti-spike monoclonal antibody for COVID-19, is limited. METHODS: We conducted a retrospective cohort study of adult SOTRs diagnosed with mild-to-moderate COVID-19 from January 2022 through May 2022 who received either bebtelovimab or sotrovimab. The primary outcome was COVID-19-related hospitalization within 30 days of COVID-19 diagnosis. Data were analyzed with Fisher's exact test. RESULTS: Among 361 SOTRs, 92 (25.5%) received bebtelovimab and 269 (74.5%) received sotrovimab. The most common organ transplant was a kidney (42.4%). SOTRs who received bebtelovimab had a higher proportion who had received a booster SARS-CoV-2 vaccine dose and had received their last vaccination dose more recently. Eleven (3.0%) SOTRs were hospitalized, and rates of hospitalization were similar between monoclonal antibody groups (3.3% versus 3.0%; p > .99). Three patients required admission to an intensive care unit, all of who received sotrovimab. Four (1.1%) patients died within 30 days of COVID-19 diagnosis, two from each group. CONCLUSIONS: SOTRs with mild-to-moderate COVID-19 who received bebtelovimab had similar rates of COVID-19-related hospitalization as those who received sotrovimab. While differences in vaccination rates and viral subvariants could act as confounders, bebtelovimab appears to be of similar effectiveness as sotrovimab.


Subject(s)
COVID-19 , Organ Transplantation , Adult , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Neutralizing , COVID-19/drug therapy , COVID-19 Testing , COVID-19 Vaccines , Humans , Organ Transplantation/adverse effects , Retrospective Studies , SARS-CoV-2 , Transplant Recipients
8.
Open Forum Infect Dis ; 9(7): ofac283, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1948427

ABSTRACT

Tixagevimab-cilgavimab is authorized for preexposure prophylaxis against coronavirus disease 2019 (COVID-19) in immunocompromised hosts. Herein, we report the clinical characteristics of 8 patients who developed COVID-19 soon after receiving tixagevimab-cilgavimab. This study emphasizes the need to maintain additional measures to prevent COVID-19 during periods of high severe acute respiratory syndrome coronavirus 2 transmission.

9.
Open Forum Infect Dis ; 9(7): ofac204, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1922311

ABSTRACT

Antispike monoclonal antibody treatment of 180 B-cell-depleted patients with mild-to-moderate coronavirus disease 2019 (COVID-19) resulted in good outcomes overall, with only 12.2% progressing to severe disease, 9.4% requiring hospitalization, 0.6% requiring mechanical ventilation, no deaths within 30 days, and 1.8% developing persistent COVID-19. Antispike monoclonal antibodies appear effective in this immunocompromised population.

10.
Lancet Infect Dis ; 22(10): 1400-1401, 2022 10.
Article in English | MEDLINE | ID: covidwho-1915196
11.
J Patient Exp ; 9: 23743735221105673, 2022.
Article in English | MEDLINE | ID: covidwho-1910237

ABSTRACT

Anti-spike monoclonal antibodies emerged as effective early treatment of high-risk individuals with mild-to-moderate COVID-19. Although their clinical and safety outcomes have been reported, patient perspectives of these experimental therapies have not been evaluated. In this survey participated by 644/2412 (26.7% response) individuals evaluated for anti-spike monoclonal antibody therapies, the majority of 523 patients who received the antibody infusion were very satisfied with their overall patient experience, the quality of care provided, and various aspects of medical care. They voiced satisfaction with the communication with providers before and during treatment, including education provided about monoclonal antibody treatment, the potential benefits and adverse effects, detailed instructions on the process of infusion, and safety protocols employed at the infusion facilities. Nearly a quarter (23.6%) of 121 patients who declined therapy indicated they would accept treatment should it be offered again. These patient perspectives may be used to guide healthcare facilities and providers in optimizing the care provided to high-risk outpatients with COVID-19.

12.
Mayo Clin Proc ; 97(9): 1641-1648, 2022 09.
Article in English | MEDLINE | ID: covidwho-1907568

ABSTRACT

OBJECTIVE: To describe and compare the clinical outcomes of bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab treatment of mild to moderate coronavirus disease 2019 (COVID-19) during the severe acute respiratory coronavirus 2 (SARS-CoV-2) B.1.617.2 Delta surge. METHODS: This is a retrospective study of high-risk patients who received bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab for mild to moderate COVID-19 between August 1, 2021, and December 1, 2021. Rates of severe disease, hospitalization, intensive care unit admission, and death were assessed. RESULTS: Among 10,775 high-risk patients who received bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab for mild to moderate COVID-19 during the Delta surge, 287 patients (2.7%) developed severe disease that led to hospitalization, oxygen supplementation, or death within 30 days after treatment. The rates of severe disease were low among patients treated with bamlanivimab-etesevimab (1.2%), casirivimab-imdevimab (2.9%), and sotrovimab (1.6%; P<.01). The higher rate of severe outcomes among patients treated with casirivimab-imdevimab may be related to a significantly lower COVID-19 vaccination rate in that cohort. Intensive care unit admission was comparable among patients treated bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab (1.0%, 1.0%, and 0.4%, respectively). CONCLUSION: This real-world study of a large cohort of high-risk patients shows low rates of severe disease, hospitalization, intensive care unit admission, and mortality after treatment with bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab for mild to moderate COVID-19 during the SARS-CoV-2 Delta surge.


Subject(s)
COVID-19 , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , COVID-19/drug therapy , COVID-19 Vaccines , Humans , Retrospective Studies , SARS-CoV-2
14.
Open forum infectious diseases ; 2022.
Article in English | EuropePMC | ID: covidwho-1898078

ABSTRACT

Tixagevimab-cilgavimab is authorized for pre-exposure prophylaxis against coronavirus disease 2019 (COVID-19) in immunocompromised hosts. Herein, we report the clinical characteristics of eight patients who developed COVID-19 soon after receiving tixagevimab-cilgavimab. This study emphasizes the need to maintain additional measures to prevent COVID-19 during periods of high SARS-CoV-2 transmission.

15.
Clin Infect Dis ; 2022 Jun 14.
Article in English | MEDLINE | ID: covidwho-1890911

ABSTRACT

In a cohort of 483 high-risk patients treated with nirmatrelvir/ritonavir for coronavirus disease-2019, two patients (0.4%) required hospitalization by day 30. Four patients (0.8%) experienced rebound of symptoms, which were generally mild, at median of 9 days after treatment, and all resolved without additional COVID-19-directed therapy.

16.
Clin Microbiol Infect ; 28(9): 1230-1235, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1821189

ABSTRACT

BACKGROUND: Oral drugs against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have received emergency use authorization for the treatment of mild-to-moderate COVID-19 in non-hospitalized patients who are at high risk for clinical progression. OBJECTIVES: To provide a clinical practice overview of first-generation oral antiviral agents against SARS-CoV-2. SOURCES: References for this review were identified through searches of PubMed, Google Scholar, bioRxiv, medRxiv, regulatory drug agencies, and pharmaceutical companies' websites up to 16 February 2022. CONTENT: Molnupiravir and nirmatrelvir and ritonavir have been authorized for use in nonhospitalized individuals with mild-to-moderate COVID-19 who are at high risk for progression. In clinical trials, molnupiravir reduced the frequency of hospitalization or death by 3% (relative risk reduction 30%), and nirmatrelvir and ritonavir by 6% (relative risk reduction 89%). Their use in clinical practice requires early administration, review of drug-drug interactions (nirmatrelvir and ritonavir), considerations of embryo-fetal toxicity (molnupiravir), and compliance with ingestion of a high number of pills. Knowledge gaps include the efficacy of these agents in vaccinated, hospitalized, or immunosuppressed individuals with prolonged SARS-CoV-2 persistence. IMPLICATIONS: First-generation oral antivirals represent progress in therapeutics against SARS-CoV-2, but also pose new challenges in clinical practice. Further advances in the development of new drugs are required.


Subject(s)
COVID-19 , SARS-CoV-2 , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Cytidine/analogs & derivatives , Humans , Hydroxylamines , Pharmaceutical Preparations , Ritonavir/therapeutic use
18.
Mayo Clin Proc ; 97(5): 943-950, 2022 05.
Article in English | MEDLINE | ID: covidwho-1702875

ABSTRACT

Bamlanivimab-etesevimab and casirivimab-imdevimab are authorized by the US Food and Drug Administration for emergency treatment of mild to moderate coronavirus disease 2019 (COVID-19) in high-risk persons. There has been no study comparing their clinical efficacy. In this retrospective study of 681 patients with mild to moderate COVID-19 during a period dominated by severe acute respiratory syndrome coronavirus 2 wild-type and alpha variants, 25 patients (3.7%) had progression to a severe outcome requiring hospitalization and oxygen supplementation within 30 days after monoclonal antibody infusion. Severe outcome was significantly higher among the 181 patients who were treated with casirivimab-imdevimab when compared with the 500 patients who received bamlanivimab-etesevimab (21 [6.6%] vs 13 [2.6%]; P=.01). Patients treated with casirivimab-imdevimab had higher odds of severe outcomes compared with those who received bamlanivimab-etesevimab (odds ratio, 2.67; 95% CI, 1.17 to 6.06). The demographic and clinical characteristics, and the time to monoclonal antibody infusion, of the 2 treatment cohorts were not significantly different. The reason behind this significant difference in the clinical outcomes is unclear, but our observations emphasize potential efficacy differences among antispike monoclonal antibodies against COVID-19. Further clinical studies using larger cohorts of patients are needed to confirm or refute these observations.


Subject(s)
COVID-19 , SARS-CoV-2 , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , COVID-19/drug therapy , Humans , Retrospective Studies
19.
J Infect Dis ; 225(2): 353-355, 2022 01 18.
Article in English | MEDLINE | ID: covidwho-1665997
20.
Mayo Clin Proc ; 97(2): 327-332, 2022 02.
Article in English | MEDLINE | ID: covidwho-1665267

ABSTRACT

Anti-spike monoclonal antibodies have proven invaluable in preventing severe outcomes from COVID-19, including hospitalization and death. The rise of the SARS-CoV-2 delta variant begs the question of whether monoclonal antibodies maintain similar efficacy now as they had when the alpha and beta variants predominated, when they were first assessed and approved. We used a retrospective cohort to compare rates of severe outcomes in an epoch in which alpha and beta were predominant compared with delta. A total of 5356 patients were infused during the alpha/beta variant-predominant (n=4874) and delta variant-predominant (n=482) era. Overall, odds of severe infection were 3.0% of patients in the alpha/beta-predominant era compared with 4.9% in the delta-predominant cohort. The unadjusted odds ratio (OR) was higher for severe disease in the delta era (OR, 1.67; 95% CI, 0.96 to 2.89), particularly when adjusted for Charlson Comorbidity Index (adjusted OR, 2.04; 95% CI, 1.30 to 3.08). The higher odds of severe infection could be due to a more virulent delta variant, although the possibility of decreased anti-spike monoclonal antibody effectiveness in the clinical setting cannot be excluded. Research into the most effective strategies for using and improving anti-spike monoclonals for the treatment of emerging variants is warranted.


Subject(s)
Antibodies, Monoclonal/therapeutic use , COVID-19/drug therapy , Immunologic Factors/therapeutic use , SARS-CoV-2/immunology , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Patient Acuity , Retrospective Studies , United States/epidemiology
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