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  1. Article ; Online: Emerging anti-spike monoclonal antibodies against SARS-CoV-2.

    Ordaya, Eloy E / Razonable, Raymund R

    Expert opinion on biological therapy

    2024  Volume 24, Issue 3, Page(s) 191–201

    Abstract: Introduction: Anti-spike monoclonal antibodies (mAbs) were previously authorized for the prevention and treatment of COVID-19 in immunocompromised patients. However, they are no longer authorized in the U.S. due to their lack of neutralizing activity ... ...

    Abstract Introduction: Anti-spike monoclonal antibodies (mAbs) were previously authorized for the prevention and treatment of COVID-19 in immunocompromised patients. However, they are no longer authorized in the U.S. due to their lack of neutralizing activity against current circulating SARS-CoV-2 Omicron variants.
    Areas covered: We summarized the available data on emergent mAbs in the early stages of clinical development. Consistent with data on prior mAbs, these novel agents have been well tolerated and demonstrated a good safety profile in early clinical trials. Additionally, many of them have been engineered to ensure prolonged half-life and combined with other mAbs to overcome the potential for emerging resistant mutants. Interestingly, one of these agents has been evaluated using an inhaled route of administration, and another agent is being evaluated for treatment of long COVID.
    Expert opinion: Although the available data of novel mAbs holds promise, we anticipate that these agents will face similar challenges encountered by prior authorized agents, including the continued evolution of SARS-CoV-2 and emergence of new escape mutations. Strategies to potentially mitigate this are discussed. Based on prior successful experience, immunocompromised patients will certainly benefit from the utilization of mAbs for the prevention and treatment of COVID-19; thus, we need to design potential interventions to ensure the sustained activity of these agents.
    MeSH term(s) Humans ; SARS-CoV-2 ; COVID-19 ; Post-Acute COVID-19 Syndrome ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Neutralizing/therapeutic use
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Neutralizing
    Language English
    Publishing date 2024-03-26
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2024.2326647
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Reply to Boodman et al.

    Ordaya, Eloy E / Abu Saleh, Omar M / Mahmood, Maryam

    Open forum infectious diseases

    2023  Volume 10, Issue 8, Page(s) ofad437

    Language English
    Publishing date 2023-08-16
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofad437
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  3. Article: Multifocal lesions of the lungs, skin, bones, and brain.

    Ordaya, Eloy E / Ries, Daniel M / Konstantinov, Nikifor K

    JAAD case reports

    2023  Volume 40, Page(s) 132–135

    Language English
    Publishing date 2023-09-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2834220-3
    ISSN 2352-5126
    ISSN 2352-5126
    DOI 10.1016/j.jdcr.2023.08.021
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  4. Article: "Let the Cat Out of the Heart": Clinical Characteristics of Patients Presenting With Blood Culture-Negative Endocarditis Due to

    Ordaya, Eloy E / Abu Saleh, Omar M / Mahmood, Maryam

    Open forum infectious diseases

    2023  Volume 10, Issue 7, Page(s) ofad293

    Abstract: Patients with blood culture-negative endocarditis due ... ...

    Abstract Patients with blood culture-negative endocarditis due to
    Language English
    Publishing date 2023-05-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofad293
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  5. Article: Strongyloidiasis complicated by gram-negative bacteremia and liver abscesses.

    Ordaya, Eloy E / Misra, Anisha / Abu Saleh, Omar M

    IDCases

    2022  Volume 27, Page(s) e01392

    Language English
    Publishing date 2022-01-08
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2745454-X
    ISSN 2214-2509
    ISSN 2214-2509
    DOI 10.1016/j.idcr.2022.e01392
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  6. Article ; Online: The Role of Novel Antifungals in the Management of Candidiasis: A Clinical Perspective.

    Ordaya, Eloy E / Clement, Josh / Vergidis, Paschalis

    Mycopathologia

    2023  Volume 188, Issue 6, Page(s) 937–948

    Abstract: Mucosal and invasive candidiasis can be challenging to treat in the setting of drug intolerance, antifungal resistance, drug-drug interactions, or host immune status. Antifungals with novel mechanisms of action and distinct pharmacokinetic/ ... ...

    Abstract Mucosal and invasive candidiasis can be challenging to treat in the setting of drug intolerance, antifungal resistance, drug-drug interactions, or host immune status. Antifungals with novel mechanisms of action and distinct pharmacokinetic/pharmacodynamic properties have been developed in recent years. Rezafungin is an echinocandin with high-tissue penetration and an extended half-life that allows for once-weekly administration, making it a convenient treatment option for invasive candidiasis while obviating the need for central catheter placement. Ibrexafungerp is an oral glucan synthase inhibitor that is active against most echinocandin-resistant Candida species. At present, it is approved for the treatment of acute vulvovaginal candidiasis and is under investigation as an oral step-down therapy following initial treatment with an echinocandin for cases of invasive candidiasis. Oteseconazole is a long-acting tetrazole that exhibits a higher affinity for the fungal enzyme CYP51, resulting in a potentially lower risk of drug-drug interactions and side effects compared to other azoles. It is currently approved for the treatment of recurrent vulvovaginal candidiasis. Fosmanogepix has a novel mechanism of action and potent activity against several Candida strains resistant to other antifungals. Due to its considerable bioavailability and tissue penetration, it holds promise as a potential treatment option in patients with invasive candidiasis, including those with chorioretinitis or meningitis. Results from clinical trials and observational studies will further delineate the role of these agents in the management of candidiasis. As the usage of these novel antifungals becomes widespread, we expect to acquire a greater understanding of their efficacy and potential benefits.
    MeSH term(s) Female ; Humans ; Antifungal Agents/pharmacology ; Antifungal Agents/therapeutic use ; Candidiasis, Vulvovaginal/drug therapy ; Echinocandins/pharmacology ; Echinocandins/therapeutic use ; Candida ; Candidiasis, Invasive/drug therapy
    Chemical Substances Antifungal Agents ; Echinocandins
    Language English
    Publishing date 2023-07-20
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 391081-7
    ISSN 1573-0832 ; 0369-299X ; 0301-486X ; 0027-5530
    ISSN (online) 1573-0832
    ISSN 0369-299X ; 0301-486X ; 0027-5530
    DOI 10.1007/s11046-023-00759-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: Clostridium Tetani Bacteremia From a Suspected Cutaneous Source.

    Kazadi, David / Zychowski, Diana / Skipper, Caleb / Teravskis, Peter / Hansen, Glen T / Ordaya, Eloy E

    Cureus

    2022  Volume 14, Issue 3, Page(s) e22848

    Abstract: Bacteremia is a rare complication ... ...

    Abstract Bacteremia is a rare complication of
    Language English
    Publishing date 2022-03-04
    Publishing country United States
    Document type Case Reports
    ZDB-ID 2747273-5
    ISSN 2168-8184
    ISSN 2168-8184
    DOI 10.7759/cureus.22848
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  8. Article ; Online: Temporal trends in antifungal susceptibility of Cryptococcus neoformans isolates from a reference laboratory in the United States, 2011-2021.

    Ordaya, Eloy E / Abu Saleh, Omar M / Vergidis, Paschalis / Deml, Sharon M / Wengenack, Nancy L / Fida, Madiha

    Mycoses

    2024  Volume 67, Issue 1, Page(s) e13691

    Abstract: Background: There are no established clinical breakpoints for antifungal agents against Cryptococcus species; however, epidemiological cut-off values can help distinguish wild-type (WT) isolates without any acquired resistance from non-WT strains, which ...

    Abstract Background: There are no established clinical breakpoints for antifungal agents against Cryptococcus species; however, epidemiological cut-off values can help distinguish wild-type (WT) isolates without any acquired resistance from non-WT strains, which may harbour resistance mechanisms.
    Patients/methods: We describe the trends of antifungal MICs and percentages of WT C. neoformans species complex (CNSC) isolates processed in our reference laboratory from November 2011 to June 2021. There were only nine isolates in 2011, thus, we included them in the year 2012 for data analysis. Clinical data is also described when available.
    Results: We identified 632 CNSC, the majority collected from blood (n = 301), cerebrospinal fluid (n = 230), and respiratory (n = 71) sources. The overall percentage of WT isolates for amphotericin B (AMB), 5-flucytosine, and fluconazole was 77%, 98%, and 91%, respectively. We noticed a statistically significant change in the percentage of AMB WT isolates over the years, with 98% of isolates being WT in 2012 compared to 79% in 2021 (p < .01). A similar change was not observed for other antifungal agents. Clinical data was available for 36 patients, primarily non-HIV immunocompromised patients with disseminated cryptococcosis. There were no statistically significant differences in the clinical characteristics and outcomes between patients with WT (58.3%) versus non-WT (41.7%) isolates, but we noticed higher mortality in patients infected with an AMB non-WT CNSC isolate.
    Conclusions: We observed an increase in the percentage of AMB non-WT CNSC isolates in the past decade. The clinical implications of this finding warrant further evaluation in larger studies.
    MeSH term(s) Humans ; United States/epidemiology ; Antifungal Agents/pharmacology ; Cryptococcus neoformans ; Cryptococcosis/drug therapy ; Cryptococcosis/epidemiology ; Cryptococcosis/microbiology ; Flucytosine/pharmacology ; Amphotericin B/pharmacology ; Fluconazole ; Microbial Sensitivity Tests
    Chemical Substances Antifungal Agents ; Flucytosine (D83282DT06) ; Amphotericin B (7XU7A7DROE) ; Fluconazole (8VZV102JFY)
    Language English
    Publishing date 2024-01-12
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 392487-7
    ISSN 1439-0507 ; 0933-7407
    ISSN (online) 1439-0507
    ISSN 0933-7407
    DOI 10.1111/myc.13691
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    Ud II Zs.176: Show issues Location:
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  9. Article ; Online: Genotypic and predicted phenotypic analysis of SARS-COV-2 Omicron subvariants in immunocompromised patients with COVID-19 following tixagevimab-cilgavimab prophylaxis.

    Ordaya, Eloy E / Vergidis, Paschalis / Razonable, Raymund R / Yao, Joseph D / Beam, Elena

    Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

    2023  Volume 160, Page(s) 105382

    Abstract: Background: Tixagevimab-cilgavimab is used for pre-exposure prophylaxis of COVID-19 in immunocompromised patients, though in vitro data has shown reduced neutralizing activity against SARS-CoV-2 Omicron subvariants.: Methods: We performed genomic ... ...

    Abstract Background: Tixagevimab-cilgavimab is used for pre-exposure prophylaxis of COVID-19 in immunocompromised patients, though in vitro data has shown reduced neutralizing activity against SARS-CoV-2 Omicron subvariants.
    Methods: We performed genomic sequencing of SARS-CoV-2 isolated from patients diagnosed with COVID-19 following tixagevimab-cilgavimab. Resistance-associated substitutions were used to generate a predicted phenotypic susceptibility analysis to tixagevimab-cilgavimab and bebtelovimab. Clinical data collected from these patients included SARS-CoV-2 immunization status, COVID-19-directed therapies, and outcomes.
    Results: SARS-CoV-2 genome sequencing was performed in 25 patients. SARS-CoV-2 Omicron BA.2 was the most common identified subvariant. All patients had viral isolates with spike codon substitutions associated with reduced susceptibility to tixagevimab-cilgavimab; their predicted phenotypic analysis showed a >2-fold reduced susceptibility to tixagevimab-cilgavimab. Two patients had viral isolates with spike codon substitutions (K444N and G446D) associated with highly reduced susceptibility to bebtelovimab, although all the viral isolates had <2-fold reduced susceptibility based on predicted phenotypic analysis. Sixteen patients received rescue therapy with bebtelovimab, but one patient with BA.2 subvariant harboring K444N mutation died of COVID-19-related complications. Five patients received other COVID-19 therapies and survived. Four had mild or asymptomatic COVID-19 with an uncomplicated course despite not receiving any additional therapy.
    Discussion: Multiple SARS-CoV-2 Omicron spike codon substitutions that correlated with reduced susceptibility to tixagevimab-cilgavimab were identified in patients with COVID-19 after receiving this monoclonal antibody. Most patients had an uncomplicated course. The identification of spike codon substitutions conferring resistance to bebtelovimab highlights the importance of performing genomic surveillance to identify new resistant SARS-CoV-2 variants.
    MeSH term(s) Humans ; SARS-CoV-2 ; COVID-19 ; Antibodies, Monoclonal ; Immunocompromised Host ; Antibodies, Neutralizing ; Antibodies, Viral
    Chemical Substances tixagevimab ; cilgavimab (1KUR4BN70F) ; Antibodies, Monoclonal ; Antibodies, Neutralizing ; Antibodies, Viral
    Language English
    Publishing date 2023-01-26
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1446080-4
    ISSN 1873-5967 ; 1386-6532
    ISSN (online) 1873-5967
    ISSN 1386-6532
    DOI 10.1016/j.jcv.2023.105382
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    Zs.A 3790: Show issues Location:
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  10. Article ; Online: Real-world experience of tixagevimab-cilgavimab pre-exposure prophylaxis in orthotopic heart transplant recipients.

    Ordaya, Eloy E / Higgins, Eibhlin M / Vergidis, Paschalis / Razonable, Raymund R / Beam, Elena

    Transplant infectious disease : an official journal of the Transplantation Society

    2023  Volume 25, Issue 3, Page(s) e14040

    Abstract: Background: Pre-exposure prophylaxis with tixagevimab-cilgavimab (tix-cil) may be associated with cardiovascular adverse events. Also, in vitro studies have reported a reduced activity of tix-cil against emerging SARS-CoV-2 Omicron subvariants. Our ... ...

    Abstract Background: Pre-exposure prophylaxis with tixagevimab-cilgavimab (tix-cil) may be associated with cardiovascular adverse events. Also, in vitro studies have reported a reduced activity of tix-cil against emerging SARS-CoV-2 Omicron subvariants. Our study aimed to report the real-world outcomes of tix-cil prophylaxis in orthotopic heart transplant (OHT) recipients METHODS: We retrospectively studied all OHT recipients who received one dose of tix-cil (150-150 mg or 300-300 mg) at Mayo Clinic in Arizona, Florida, and Minnesota, between February 5, 2022 and September 8, 2022. We collected data on cardiovascular adverse events and breakthrough COVID-19 following tix-cil administration.
    Results: One hundred sixty-three OHT recipients were included. The majority were male (65.6%), and the median age was 61 years (IQR 48, 69). During the median follow-up of 164 days (IQR 123, 190), one patient presented an episode of asymptomatic hypertensive urgency that was managed with outpatient antihypertensive treatment optimization. Twenty-four patients (14.7%) experienced breakthrough COVID-19 at the median of 63.5 days (IQR 28.3, 101.3) after tix-cil administration. The majority (70.8%) completed the primary vaccine series and received at least one booster dose (70.8%). Only one patient with breakthrough COVID-19 required hospitalization. All patients survived.
    Conclusions: In this cohort of OHT recipients, no patients developed severe cardiovascular events related to tix-cil. The high incidence of breakthrough COVID-19 could be due to the reduced activity of tix-cil against current circulating SARS-CoV-2 Omicron variants. These results emphasize the need for a multimodal prevention strategy against SARS-CoV-2 in these high-risk patients.
    MeSH term(s) Humans ; Female ; Male ; Middle Aged ; COVID-19/prevention & control ; Pre-Exposure Prophylaxis ; Retrospective Studies ; SARS-CoV-2 ; Heart Transplantation/adverse effects ; Transplant Recipients
    Chemical Substances cilgavimab (1KUR4BN70F) ; tixagevimab
    Language English
    Publishing date 2023-02-27
    Publishing country Denmark
    Document type Journal Article
    ZDB-ID 1476094-0
    ISSN 1399-3062 ; 1398-2273
    ISSN (online) 1399-3062
    ISSN 1398-2273
    DOI 10.1111/tid.14040
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