Lower Incidence of Cytomegalovirus and Bk Virus With Everolimus Versus Mycophenolate in De Novo Renal Transplant Patients: Results From a Multicenter, Prospective Study

Kim, Y. S.; Tedesco‐Silva, Hélio; Johnston, Thomas D.; Lee, P.; Zibari, Gazi B.; Walker, Rowan G.; Mange, K.; Wang, Z.; Cibrik, Diane M.

doi:10.1097/00007890-201007272-00485

Cited by 5 publications

(3 citation statements)

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“…Although everolimus was first used in kidney transplantation [28,29], it has demonstrated to be useful in other SOTs (e.g., heart transplantation, where an advantage in the avoidance of allograft vasculopathy has been reported as well as a lesser incidence of CMV-related events [30]). The reduction in CMV infections with everolimus (versus azathioprine or mycophenolate) [30][31][32][33][34][35] is independent of CMV prophylaxis and D/R serostatus [36].…”

Section: Discussionmentioning

confidence: 99%

A Retrospective Review of Calcineurin Inhibitors’ Impact on Cytomegalovirus Infections in Lung Transplant Recipients

et al. 2021

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Immunosuppressive therapy reduces the risk for allograft rejection but leaves recipients susceptible to infections. Cytomegalovirus (CMV) is one of the most frequent causes for infection after transplantation and increases the risk for allograft rejection. As lung transplant recipients (LTRs) need to be under immunosuppression for life, they are a vulnerable group. To determine the potential association between the development of CMV infection and the calcineurin inhibitor (CNI) blood levels within previous 90 days, a retrospective review of LTRs was performed. Data from recipients who underwent a lung transplantation (LTx) at our center from January 2011 to December 2018 were collected. The studied recipients, after case/control matching, included 128 CMV-infection cases. The median time from the transplant to the first positive CMV viral load was 291.5 days. In our study, more patients were treated with tacrolimus (91.9%) than with cyclosporine (8.1%). Drug blood levels at selected timepoints showed no statistically significant difference between cases and controls. However, we found that CMV infection was more frequent in the donor-seropositive/recipient-seronegative group, interstitial lung disease (ILD) recipients, LTRs who underwent basiliximab induction, cyclosporine treated recipients, and LTRs with lymphopenia (at the time of CMV infection and 90 days before). In this review of LTRs, no association between the CNI blood level and CMV infection was seen, although other immunity-related factors were found to be influencing, i.e., basiliximab induction, cyclosporine treatment, and lymphopenia.

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Section: Discussionmentioning

confidence: 99%

A Retrospective Review of Calcineurin Inhibitors’ Impact on Cytomegalovirus Infections in Lung Transplant Recipients

et al. 2021

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“…111 In two everolimus studies, the incidence of cytomegalovirus infection was lower among patients receiving everolimus. 52,64,112 In the A2309 study, the incidences of cytomegalovirus infection (0.7%, 0.0%, and 5.9%), syndrome (1.5%, 1.4%, and 4.4%), and disease (0.7%, 0.7%, and 2.2%) were higher among patients receiving mycophenolate sodium. 64,112 The prevalence of polyoma virus-associated nephropathy in renal transplant recipients varies from 1% to 10%, reflecting differences in intensity of immunosuppressive regimens and in diagnostic approaches.…”

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confidence: 98%

“…113 In the A2309 trial, patients receiving everolimus showed a lower incidence of BK viruria (0.7 versus 0.4 versus 3.3), viremia (1.1 versus 0.7 versus 1.8) and nephropathy (0.4 versus 0.0 versus 0.7) compared with those receiving mycophenolate sodium. 64,112 Cyclosporine-related adverse events…”

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Impact of everolimus: update on immunosuppressive therapy strategies and patient outcomes after renal transplantation

Tedesco‐Silva¹,

Felipe²,

Freitas³

et al. 2011

TRRM

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Everolimus is an immunosuppressive agent used for the prophylaxis of acute rejection after kidney transplantation. Everolimus inhibits the activity of the serine/threonine kinase mammalian target of rapamycin (mTOR), a key enzyme that controls cell growth and metabolism, producing cell cycle arrest from the G1 to S phase. As a consequence, everolimus has antiproliferative and antineoplastic effects. Everolimus is a drug with a narrow therapeutic index. The pharmacokinetics of everolimus indicates a need for twice-daily dosing. Intra-and interindividual variability and drug-drug interactions suggest the need for therapeutic drug monitoring to maximize the efficacy/toxicity ratio. The good correlation between exposure (area under the concentration-time curve) and trough concentration indicates that monitoring of everolimus trough concentrations is an adequate strategy after kidney transplantation. Everolimus is indicated for low-to moderate-risk de novo kidney transplant candidates. There are no conclusive studies thus far indicating that everolimus can be used in high-risk patients, such as sensitized patients, retransplants, and African Americans. In de novo kidney transplant recipients, the recommended initial dose of everolimus is 0.75 mg twice daily, adjusted to maintain blood trough concentrations of 3-8 ng/mL, in combination with progressive reduction in blood trough cyclosporine concentrations to 25-50 ng/mL. In combination with reduced trough blood tacrolimus concentrations of 4-7 ng/mL the recommended initial dose of everolimus is 1.5 mg twice daily, adjusted to maintain trough blood concentrations of 3-8 ng/mL. Everolimus can also be used as a conversion strategy, mainly to preserve renal function and to manage patients with malignancy. There is no definition of the ideal strategy for conversion, ie, abrupt or sequential, initial dose of everolimus, or target therapeutic trough blood concentrations. Intensive monitoring is recommended after conversion, especially for acute rejection and proteinuria. Because mTOR is ubiquitous and central to many intracellular processes, an array of adverse reactions may occur, including delayed tissue regeneration, proteinuria, dyslipidemia, diabetes, myelosuppression, infertility, ovarian cysts, and mouth ulcers. Because long-term benefits are the goal of any immunosuppressive strategy, further investigations aiming to understand, prevent, and manage everolimus-related adverse reactions are necessary to mitigate the risks and improve tolerability, allowing maximization of all the benefits of this drug.

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Target of rapamycin inhibitors (TOR-I; sirolimus and everolimus) for primary immunosuppression in kidney transplant recipients

Hahn

Hodson

Hamiwka

et al. 2019

Cochrane Database of Systematic Reviews

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Lower Incidence of Cytomegalovirus and Bk Virus With Everolimus Versus Mycophenolate in De Novo Renal Transplant Patients: Results From a Multicenter, Prospective Study

Cited by 5 publications

References 0 publications

A Retrospective Review of Calcineurin Inhibitors’ Impact on Cytomegalovirus Infections in Lung Transplant Recipients

A Retrospective Review of Calcineurin Inhibitors’ Impact on Cytomegalovirus Infections in Lung Transplant Recipients

Impact of everolimus: update on immunosuppressive therapy strategies and patient outcomes after renal transplantation

Target of rapamycin inhibitors (TOR-I; sirolimus and everolimus) for primary immunosuppression in kidney transplant recipients

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