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  1. Article ; Online: Response to Yates and Halliday regarding CMV DNAemia and time-to-mortality in a Randomized Trial of PET vs AP in CMV D+R-Liver Transplant Recipients.

    Kumar, Lakshin / Dasgupta, Sayan / Murray-Krezan, Cristina / Singh, Nina / Rakita, Robert M / Fisher, Cynthia E / Limaye, Ajit P

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2024  

    Language English
    Publishing date 2024-01-08
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciae005
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  2. Article ; Online: A practical guide to real-world implementation of pre-emptive therapy for Cytomegalovirus disease prevention in high-risk seronegative liver transplant recipients with seropositive donors.

    Heldman, Madeleine R / Dunn, Bailey / Clemens, Evan / Henderson, Megan / Fisher, Cynthia E / Rakita, Robert M / Kling, Catherine E / Limaye, Ajit P

    Transplant infectious disease : an official journal of the Transplantation Society

    2024  , Page(s) e14229

    Abstract: The Comparison of Antiviral Preventative Strategies In Liver Transplant (CAPSIL) study showed pre-emptive therapy (PET) to be superior to antiviral prophylaxis for Cytomegalovirus (CMV) disease prevention in high-risk CMV seronegative liver transplant ... ...

    Abstract The Comparison of Antiviral Preventative Strategies In Liver Transplant (CAPSIL) study showed pre-emptive therapy (PET) to be superior to antiviral prophylaxis for Cytomegalovirus (CMV) disease prevention in high-risk CMV seronegative liver transplant recipients (LTRs) with seropositive donors (D
    Language English
    Publishing date 2024-01-12
    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.14229
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  3. Article ; Online: Apples to apples: The challenges of studying COVID-19 mortality in solid organ transplant recipients.

    Heldman, Madeleine R / Rakita, Robert M / Lease, Erika D / Fisher, Cynthia E / Limaye, Ajit P

    American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

    2022  Volume 22, Issue 7, Page(s) 1929–1930

    MeSH term(s) COVID-19 ; Humans ; Malus ; Organ Transplantation ; SARS-CoV-2 ; Transplant Recipients
    Language English
    Publishing date 2022-02-15
    Publishing country United States
    Document type Letter ; Research Support, N.I.H., Extramural ; Comment
    ZDB-ID 2060594-8
    ISSN 1600-6143 ; 1600-6135
    ISSN (online) 1600-6143
    ISSN 1600-6135
    DOI 10.1111/ajt.16989
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  4. Article ; Online: Association of Cytomegalovirus (CMV) DNAemia With Long-Term Mortality in a Randomized Trial of Preemptive Therapy and Antiviral Prophylaxis for Prevention of CMV Disease in High-Risk Donor Seropositive, Recipient Seronegative Liver Transplant Recipients.

    Kumar, Lakshin / Dasgupta, Sayan / Murray-Krezan, Cristina / Singh, Nina / Rakita, Robert M / Fisher, Cynthia E / Limaye, Ajit P

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2023  Volume 78, Issue 3, Page(s) 719–722

    Abstract: In a post-hoc analysis of the association of CMV DNAemia with long-term mortality in a randomized trial of CMV preemptive therapy vs. antiviral prophylaxis in D+R- liver transplant recipients, post-intervention CMV DNAemia was associated with increased ... ...

    Abstract In a post-hoc analysis of the association of CMV DNAemia with long-term mortality in a randomized trial of CMV preemptive therapy vs. antiviral prophylaxis in D+R- liver transplant recipients, post-intervention CMV DNAemia was associated with increased mortality after adjusting for study arm.
    MeSH term(s) Humans ; Antiviral Agents/therapeutic use ; Cytomegalovirus/genetics ; Cytomegalovirus Infections/drug therapy ; Liver Transplantation ; Tissue Donors ; Transplant Recipients ; Randomized Controlled Trials as Topic
    Chemical Substances Antiviral Agents
    Language English
    Publishing date 2023-10-19
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciad643
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  5. Article ; Online: Real-world effectiveness of preemptive therapy (PET) for cytomegalovirus (CMV) disease prevention in CMV high-risk donor seropositive/recipient seronegative (D+R-) liver transplant recipients (LTxR).

    Doss, Kathleen M / Kling, Catherine E / Heldman, Madeleine R / Singh, Nina / Wagener, Marilyn / Rakita, Robert M / Fisher, Cynthia E / Limaye, Ajit P

    Transplant infectious disease : an official journal of the Transplantation Society

    2023  Volume 25, Issue 2, Page(s) e14015

    Abstract: Background: Despite superiority of preemptive therapy (PET) compared to universal prophylaxis for prevention of cytomegalovirus (CMV) disease in the CAPSIL randomized trial among CMV D+R- liver transplant recipients (LTxRs), real-world effectiveness may ...

    Abstract Background: Despite superiority of preemptive therapy (PET) compared to universal prophylaxis for prevention of cytomegalovirus (CMV) disease in the CAPSIL randomized trial among CMV D+R- liver transplant recipients (LTxRs), real-world effectiveness may be lower because of logistical concerns about feasibility of PET.
    Methods: We retrospectively assessed PET as standard clinical care at a single transplant center among 50 consecutive adult CMV D+R- LTxRs undergoing a first liver transplant between 4/4/2019 and 5/18/2021 and compared outcomes and adherence to those randomized to PET in the CAPSIL study (N = 100). The primary outcome was CMV disease and secondary outcomes were biopsy-confirmed acute allograft rejection, retransplant, invasive fungal infections, and death, all assessed by 1-year post-transplant. Exploratory outcomes included virologic parameters and measures of adherence to protocol-specified CMV qPCR monitoring.
    Results: Baseline characteristics were similar between groups. The cumulative incidence of CMV disease at 1-year post-transplant was 4/50 (8%) versus 9/100 (9%) in the real-world and CAPSIL cohorts, respectively, p = 1.0. The rate of breakthrough CMV disease during the 100-day PET period was low (2/50 [4%]) and similar to the PET cohort from the CAPSIL study (3/100 [3%]).  All secondary and exploratory outcomes were not significantly different between the real-world and CAPSIL PET cohorts.
    Conclusions: In this first reported study of real-world PET, the feasibility and effectiveness for CMV disease prevention and for other clinical outcomes in CMV D+R- LTxRs were similar to those reported with PET in a clinical trial. Additional studies to confirm feasibility and generalizability in other settings are warranted.
    MeSH term(s) Adult ; Humans ; Cytomegalovirus ; Antiviral Agents/therapeutic use ; Liver Transplantation/adverse effects ; Retrospective Studies ; Treatment Outcome ; Cytomegalovirus Infections/epidemiology ; Cytomegalovirus Infections/prevention & control ; Cytomegalovirus Infections/drug therapy ; Positron-Emission Tomography/adverse effects ; Transplant Recipients ; Ganciclovir/therapeutic use
    Chemical Substances Antiviral Agents ; Ganciclovir (P9G3CKZ4P5)
    Language English
    Publishing date 2023-02-03
    Publishing country Denmark
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 1476094-0
    ISSN 1399-3062 ; 1398-2273
    ISSN (online) 1399-3062
    ISSN 1398-2273
    DOI 10.1111/tid.14015
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  6. Article: A Systematic Review and Meta-analysis of Optimized CMV Preemptive Therapy and Antiviral Prophylaxis for CMV Disease Prevention in CMV High-Risk (D+R-) Kidney Transplant Recipients.

    Kumar, Lakshin / Murray-Krezan, Cristina / Singh, Nina / Brennan, Daniel C / Rakita, Robert M / Dasgupta, Sayan / Fisher, Cynthia E / Limaye, Ajit P

    Transplantation direct

    2023  Volume 9, Issue 8, Page(s) e1514

    Abstract: The optimal strategy for cytomegalovirus (CMV) disease prevention in CMV donor/recipient kidney transplant recipients remains uncertain. Conclusions of prior meta-analyses that CMV disease rates with preemptive therapy (PET) and universal prophylaxis (UP) ...

    Abstract The optimal strategy for cytomegalovirus (CMV) disease prevention in CMV donor/recipient kidney transplant recipients remains uncertain. Conclusions of prior meta-analyses that CMV disease rates with preemptive therapy (PET) and universal prophylaxis (UP) were comparable may have been affected by inclusion of studies lacking key determinants of efficacy of the respective strategies.
    Methods: We conducted a systematic review and meta-analysis of PET with weekly CMV polymerase chain reaction monitoring for ≥3 mo and UP with 6 mo of valganciclovir. PubMed and Embase databases were reviewed from January 1, 2010, to April 1, 2022. Risk of bias was assessed with 3 instruments (Cochrane RoB, Cochrane RoBINS-I, and an instrument for assessing risk in observational studies). The primary outcome was CMV disease incidence by 1-y posttransplant. Secondary outcomes by 1-y were graft loss, acute allograft rejection, and mortality. Results were synthesized using generalized linear mixed model meta-analysis. PET studies were stratified into low-threshold (LT) and high-threshold (HT) PET based on the viral load threshold for initiation of antiviral therapy.
    Results: Twenty-five studies met inclusion criteria (6 PET, 19 UP). CMV disease incidence was significantly higher in HT (0.30 [95% confidence interval (CI), 0.22-0.39]) versus LT PET (0.06 [95% CI, 0.03-0.12]). LT PET was associated with a significantly lower CMV disease incidence (0.06 [95% CI, 0.03-0.12]) versus UP (0.21 [95% CI, 0.17-0.27]). Incidence of graft loss, acute allograft rejection, or mortality was not significantly different between LT PET and UP (
    Conclusions: LT PET is associated with a significantly lower incidence of CMV disease compared to UP with similar rates of other clinical outcomes. These findings provide rationale and preliminary data for a randomized superiority trial of optimized LT-PET versus UP in donor seropositive recipient seronegative kidney transplant recipients.
    Language English
    Publishing date 2023-07-12
    Publishing country United States
    Document type Journal Article
    ISSN 2373-8731
    ISSN 2373-8731
    DOI 10.1097/TXD.0000000000001514
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  7. Article ; Online: Combined assessment of Epstein-Barr virus viral capsid antigen and Epstein-Barr virus nuclear antigen-1 serology for post-transplant lymphoproliferative disorder risk stratification in adult solid organ transplant recipients.

    Heldman, Madeleine R / Edlefsen, Kerstin L / Pepper, Gregory / Kapnadak, Siddhartha G / Rakita, Robert M / Fisher, Cynthia E / Limaye, Ajit P

    Transplant infectious disease : an official journal of the Transplantation Society

    2022  Volume 24, Issue 6, Page(s) e13933

    Abstract: Background: Epstein-Barr virus (EBV) seronegative solid organ transplant recipients (SOTRs) are at increased risk for post-transplant lymphoproliferative disorder (PTLD). Assays for EBV serostatus assess antibody to both EBV viral capsid antigen (VCA) ... ...

    Abstract Background: Epstein-Barr virus (EBV) seronegative solid organ transplant recipients (SOTRs) are at increased risk for post-transplant lymphoproliferative disorder (PTLD). Assays for EBV serostatus assess antibody to both EBV viral capsid antigen (VCA) and Epstein-Barr nuclear antigen-1 (EBNA-1), but PTLD risk among SOT recipients with discordant VCA and EBNA-1 results is unknown.
    Methods: We performed a retrospective, single-center cohort study to determine the risk of PTLD among adult (≥ 18 years) SOTRs with discordant pre-transplant VCA and EBNA-1 IgG compared to that of SOTRs with concordantly negative or concordantly positive serology using univariable and multivariable Cox-proportional hazards models.
    Results: Of 4106 SOTRs, the number (%) who were concordantly positive, concordantly negative, and discordant was 3787 (92.2%), 149 (3.6%), and 170 (4.2%), respectively. The adjusted hazard of PTLD was significantly higher among discordant SOTRs compared to concordantly positive SOTRs (aHR 2.6, 95% CI 1.04-6.6, p =.04) and lower compared to concordantly negative SOTRs (aHR 0.27, 95% CI 0.10-0.76, p <.001). The adjusted hazard of EBV+ PTLD among those with discordant serology was also significantly higher compared to the concordantly positive cohort (aHR 3.53, 95% CI 1.04-12.0, p =.04) and significantly lower compared to the concordantly negative cohort (aHR 0.23, 95% CI 0.06-0.82, p =.02).
    Conclusions: Risk of PTLD among SOTRs with discordant VCA and EBNA-1 may be intermediate between those with concordantly positive and negative serology. If confirmed in future studies, revision of national EBV serology reporting to include both VCA and EBNA results may be needed to optimize PTLD risk stratification.
    MeSH term(s) Adult ; Humans ; Epstein-Barr Virus Nuclear Antigens ; Herpesvirus 4, Human ; Epstein-Barr Virus Infections/complications ; Retrospective Studies ; Cohort Studies ; Capsid ; Lymphoproliferative Disorders/etiology ; Organ Transplantation/adverse effects ; Risk Assessment
    Chemical Substances EBV-encoded nuclear antigen 1 (O5GA75RST7) ; Epstein-Barr Virus Nuclear Antigens
    Language English
    Publishing date 2022-09-06
    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.13933
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  8. Article ; Online: Emerging evidence to support not always "just saying no" to SARS-CoV-2 positive donors.

    Kates, Olivia S / Fisher, Cynthia E / Rakita, Robert M / Reyes, Jorge D / Limaye, Ajit P

    American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

    2020  Volume 20, Issue 11, Page(s) 3261–3262

    MeSH term(s) COVID-19/epidemiology ; COVID-19/transmission ; DNA, Viral/analysis ; Disease Transmission, Infectious/prevention & control ; Humans ; Organ Transplantation/methods ; Pandemics ; SARS-CoV-2/genetics ; Tissue Donors ; Tissue and Organ Procurement/methods
    Chemical Substances DNA, Viral
    Keywords covid19
    Language English
    Publishing date 2020-06-18
    Publishing country United States
    Document type Letter
    ZDB-ID 2060594-8
    ISSN 1600-6143 ; 1600-6135
    ISSN (online) 1600-6143
    ISSN 1600-6135
    DOI 10.1111/ajt.16119
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  9. Article ; Online: Reply to Hage and Schuurmans.

    Kates, Olivia S / Rakita, Robert M / Lease, Erika D / Fisher, Cynthia E / Limaye, Ajit P

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2020  Volume 73, Issue 9, Page(s) e2833–e2834

    Language English
    Publishing date 2020-10-26
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciaa1633
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  10. Article ; Online: Use of SARS-CoV-2-infected deceased organ donors: Should we always "just say no?"

    Kates, Olivia S / Fisher, Cynthia E / Rakita, Robert M / Reyes, Jorge D / Limaye, Ajit P

    American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

    2020  Volume 20, Issue 7, Page(s) 1787–1794

    Abstract: In the context of a rapidly evolving pandemic, multiple organizations have released guidelines stating that all organs from potential deceased donors with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection should be deferred, ... ...

    Abstract In the context of a rapidly evolving pandemic, multiple organizations have released guidelines stating that all organs from potential deceased donors with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection should be deferred, including from otherwise medically eligible donors found to have mild or asymptomatic SARS-CoV-2 discovered on routine donor screening. In this article, we critically examine the available data on the risk of transmission of SARS-CoV-2 through organ transplantation. The isolation of SARS-CoV-2 from nonlung clinical specimens, the detection of SARS-CoV-2 in autopsy specimens, previous experience with the related coronaviruses SARS-CoV and MERS-CoV, and the vast experience with other common RNA respiratory viruses are all addressed. Taken together, these data provide little evidence to suggest the presence of intact transmissible SARS-CoV in organs that can potentially be transplanted, specifically liver and heart. Other considerations including ethical, financial, societal, and logistical concerns are also addressed. We conclude that, for selected patients with high waitlist mortality, transplant programs should consider accepting heart or liver transplants from deceased donors with SARS-CoV-2 infection.
    MeSH term(s) Betacoronavirus ; COVID-19 ; Coronavirus Infections/prevention & control ; Coronavirus Infections/transmission ; Ethics, Medical ; Heart/virology ; Heart Transplantation/adverse effects ; Heart Transplantation/trends ; Humans ; Liver/virology ; Liver Transplantation/adverse effects ; Liver Transplantation/trends ; Lung/virology ; Occupational Exposure ; Pandemics/prevention & control ; Pneumonia, Viral/prevention & control ; Pneumonia, Viral/transmission ; SARS-CoV-2 ; Severe Acute Respiratory Syndrome/prevention & control ; Tissue Donors ; Tissue and Organ Procurement/ethics ; Tissue and Organ Procurement/standards ; Tissue and Organ Procurement/trends ; Waiting Lists
    Keywords covid19
    Language English
    Publishing date 2020-06-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2060594-8
    ISSN 1600-6143 ; 1600-6135
    ISSN (online) 1600-6143
    ISSN 1600-6135
    DOI 10.1111/ajt.16000
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