Management of cytomegalovirus infection in solid organ transplant recipients: SET/GESITRA-SEIMC/REIPI recommendations

Torre‐Cisneros, Julián; Aguado, José María; Castón, Juan José; Almenar, Luís; Alonso, Ángel; Cantisán, Sara; Carratalà, Jordi; Cervera, Carlos; Cordero, Elisa; Fariñas, María Carmen; Fernández‐Ruiz, Mario; Fortün, Jesús; Frauca, E; Gavaldá, Joan; Hernández, Domingo; Herrero, Ignacio; Len, Óscar; López‐Medrano, Francisco; Manito, Nicolás; Marcos, M.Á.; Martín-Dávila, Pilar; Monforte, Vı́ctor; Montejo, Miguel; Moreno, Asunción; Muñóz, Patricia; Navarro, David; Pérez‐Romero, Pilar; Rodriguez-Bernot, A.; Rumbao, José; Juan, Rafael San; Vaquero, José M.; Vidal, Elisa

doi:10.1016/j.trre.2016.04.001

Cited by 105 publications

(117 citation statements)

References 309 publications

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“…in prevention of CMV and 5 mg/kg b.i.d. in treatment of CMV—in line with international guidelines—leads to considerable underexposure in pediatric patients. When using ganciclovir as universal prophylaxis to prevent CMV, there is an established AUC 0–24 target range of 40–60 μg ∙ hour/mL, which was also used to develop the pediatric dosing algorithm of valganciclovir.…”

Section: Discussionmentioning

confidence: 73%

Pediatric Dosing of Ganciclovir and Valganciclovir: How Model‐Based Simulations Can Prevent Underexposure and Potential Treatment Failure

Jorga¹,

Reigner

Chavanne

et al. 2018

CPT Pharmacom & Syst Pharma

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Intravenous ganciclovir and oral valganciclovir are effective in the prevention and treatment of pediatric cytomegalovirus ( CMV ) infection but various dosing regimens are used in medical practice. Population pharmacokinetic (PopPK) model‐based simulations were used to propose a new ganciclovir pediatric dosing algorithm for regulatory review and to evaluate the approved valganciclovir pediatric dosing algorithm against published dosing recommendations derived from quantitative approaches. Oral valganciclovir (mg = 7 × body surface area ( BSA ) × creatinine clearance according to the Schwarz formula (Cr CLS ) daily) and i.v. ganciclovir (mg = 3 × BSA × Cr CLS daily) are effective in reaching ganciclovir target exposure for the prevention of CMV (area under the concentration‐time curve ( AUC ) 0–24 40–60 μg ∙ hour/ mL ) in most pediatric patients across the full pediatric age range. In contrast, ganciclovir and valganciclovir dosing based on body weight, as commonly used in medical practice, leads to underexposure, particularly in younger pediatric patients. This example shows that model‐based dosing algorithms built on clinical pharmacology and implemented using good modeling practice can prevent underexposure and reduce the risk of treatment failure in pediatric patients.

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Section: Discussionmentioning

confidence: 73%

Pediatric Dosing of Ganciclovir and Valganciclovir: How Model‐Based Simulations Can Prevent Underexposure and Potential Treatment Failure

Jorga¹,

Reigner

Chavanne

et al. 2018

CPT Pharmacom & Syst Pharma

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“…In our study we did not directly evaluate whether the development of indirect effects in the form of allograft dysfunction were related to CMV. In addition, lung transplant patients are also at risk of general indirect effects of CMV infection including bacterial and fungal infection, acute rejection and increased risk of post‐transplant lymphoproliferative disorder which may impact mortality …”

Section: Discussionmentioning

confidence: 99%

Impact of donor and recipient cytomegalovirus serology on long‐term survival of lung transplant recipients

Mabilangan

Preiksaitis

Cervera

2018

Transplant Infectious Dis

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“…Lower CMV viral loads not associated with a risk of invasive CMV disease may still be associated with the indirect effects of CMV. However, with a poor understanding of how antiviral therapy alters the indirect effects of CMV and the association of CMV viral loads with indirect CMV effects, there are no definite recommendations regarding antiviral therapy for this indication [28, 29]. …”

Section: Discussionmentioning

confidence: 99%

Cytomegalovirus viraemia and mortality in renal transplant recipients in the era of antiviral prophylaxis. Lessons from the western Australian experience

et al. 2017

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BackgroundCytomegalovirus (CMV) establishes a lifelong infection that is efficiently controlled by the immune system; this infection can be reactivated in case of immunosuppression such as following solid organ transplantation. CMV viraemia has been associated with CMV disease, as well as increased mortality and allograft failure. Prophylactic antiviral medication is routinely given to renal transplant recipients, but reactivation during and following cessation of antiviral prophylaxis is known to occur. The aims of this study were to assess the incidence, timing and impact of CMV viraemia in renal transplant recipients and to determine the level of viraemia associated with adverse clinical outcomes.MethodsData from all adult (18 years and over) Western Australian renal transplant recipients transplanted between 1 January 2007 and 31 December 2012 were obtained from the Australia and New Zealand Dialysis and Transplant registry and were supplemented with data obtained from clinical records. Potential risk factors for detectable CMV viraemia (≥600 copies/ml) and all-cause mortality were assessed using univariable analysis and Cox Proportional Hazards Regression.ResultsThere were 438 transplants performed on 435 recipients. The following factors increased the risk of CMV viraemia with viral loads ≥600 copies/ml: Donor positive/Recipient negative status; receiving a graft from a deceased donor; and receiving a graft from a donor aged 60 years and over. CMV viraemia with viral loads ≥656 copies/ml was a risk factor for death following renal transplantation, as was being aged 65 years and above at transplant, being Aboriginal and having vascular disease. Importantly 37% of the episodes of CMV viraemia with viral loads ≥656 copies/ml occurred while the patients were expected to be on CMV prophylaxis.ConclusionsCMV viraemia (≥656 copies/ml) was associated with all-cause mortality in multivariable analysis, and CMV viraemia at ≥656 copies/ml commonly occurred during the period when renal transplant recipients were expected to be on antiviral prophylaxis. A greater vigilance in monitoring CMV levels if antiviral prophylaxis is stopped prematurely or poor patient compliance is suspected could protect some renal transplant recipients from adverse outcomes such as premature mortality.

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Management of cytomegalovirus infection in solid organ transplant recipients: SET/GESITRA-SEIMC/REIPI recommendations

Cited by 105 publications

References 309 publications

Pediatric Dosing of Ganciclovir and Valganciclovir: How Model‐Based Simulations Can Prevent Underexposure and Potential Treatment Failure

Pediatric Dosing of Ganciclovir and Valganciclovir: How Model‐Based Simulations Can Prevent Underexposure and Potential Treatment Failure

Impact of donor and recipient cytomegalovirus serology on long‐term survival of lung transplant recipients

Cytomegalovirus viraemia and mortality in renal transplant recipients in the era of antiviral prophylaxis. Lessons from the western Australian experience

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