Cytomegalovirus and paediatric renal transplants: is this a current issue?
Citomegalovirus y trasplante renal pediátrico: ¿es un problema actualmente?
Julia Fijo López-Viotaa, Julia Fijo-López-Viotab, Laura Espinosa Románc, Laura Espinosa-Románd, Carlos Herrero Hernandoe, Carlos Herrero-Hernandof, Mª José Sanahuja Ibáñezg, M. José Sanahuja-Ibáñezh, Anna Vila Santandreui, Anna Vila-Santandreuj, Juan Manuel Praena - Fernándezk, Juan M. Praena-Fernándezl
a Unidad de Nefrología Pediátrica. Servicio de Pediatría, HH. UU. Virgen del Rocío Sevilla, Sevilla, Spain,
b Unidad de Nefrología Pediátrica. Servicio de Pediatría, Hospital Universitario Virgen del Rocío, Sevilla,
c Unidad de Nefrología Pediátrica. Servicio de Pediatría, H. U. La Paz, Madrid, Madrid, Spain,
d Unidad de Nefrología Pediátrica. Servicio de Pediatría, Hospital Universitario La Paz, Madrid,
e Unidad de Nefrología Pediátrica. Servicio de Pediatría, H. Vall d'Hebron, Barcelona, Barcelona, Spain,
f Unidad de Nefrología Pediátrica. Servicio de Pediatría, Hospital Universitari Vall d'Hebron, Barcelona,
g Unidad de Nefrología Pediátrica. Servicio de Pediatría, H. U. La Fe, Valencia, Valencia, Spain,
h Unidad de Nefrología Pediátrica. Servicio de Pediatría, Hospital Universitario La Fe, Valencia,
i Unidad de Nefrología Pediátrica. Servicio de Pediatría, H. Sant Joan de Deu, Barcelona, Barcelona, Spain,
j Unidad de Nefrología Pediátrica. Servicio de Pediatría, Hospital Maternoinfantil Sant Joan de Déu, Barcelona,
k Unidad de Estadística, Metodología y Evaluación de la Investigación, HH. UU. Virgen del Rocío, Sevilla, Sevilla, Spain,
l Unidad de Estadística, Metodología y Evaluación de la Investigación, Hospital Universitario Virgen del Rocío, Sevilla,
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Servicio de Pediatría, Hospital Universitario La Paz, Madrid, " "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "affd" ] 4 => array:3 [ "entidad" => "Unidad de Nefrología Pediátrica. Servicio de Pediatría, H. Vall d'Hebron, Barcelona, Barcelona, Spain, " "etiqueta" => "<span class="elsevierStyleSup">e</span>" "identificador" => "affe" ] 5 => array:3 [ "entidad" => "Unidad de Nefrología Pediátrica. Servicio de Pediatría, Hospital Universitari Vall d'Hebron, Barcelona, " "etiqueta" => "<span class="elsevierStyleSup">f</span>" "identificador" => "afff" ] 6 => array:3 [ "entidad" => "Unidad de Nefrología Pediátrica. Servicio de Pediatría, H. U. La Fe, Valencia, Valencia, Spain, " "etiqueta" => "<span class="elsevierStyleSup">g</span>" "identificador" => "affg" ] 7 => array:3 [ "entidad" => "Unidad de Nefrología Pediátrica. Servicio de Pediatría, Hospital Universitario La Fe, Valencia, " "etiqueta" => "<span class="elsevierStyleSup">h</span>" "identificador" => "affh" ] 8 => array:3 [ "entidad" => "Unidad de Nefrología Pediátrica. Servicio de Pediatría, H. Sant Joan de Deu, Barcelona, Barcelona, Spain, " "etiqueta" => "<span class="elsevierStyleSup">i</span>" "identificador" => "affi" ] 9 => array:3 [ "entidad" => "Unidad de Nefrología Pediátrica. Servicio de Pediatría, Hospital Maternoinfantil Sant Joan de Déu, Barcelona, " "etiqueta" => "<span class="elsevierStyleSup">j</span>" "identificador" => "affj" ] 10 => array:3 [ "entidad" => "Unidad de Estadística, Metodología y Evaluación de la Investigación, HH. UU. Virgen del Rocío, Sevilla, Sevilla, Spain, " "etiqueta" => "<span class="elsevierStyleSup">k</span>" "identificador" => "affk" ] 11 => array:3 [ "entidad" => "Unidad de Estadística, Metodología y Evaluación de la Investigación, Hospital Universitario Virgen del Rocío, Sevilla, " "etiqueta" => "<span class="elsevierStyleSup">l</span>" "identificador" => "affl" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Citomegalovirus y trasplante renal pediátrico: ¿es un problema actualmente?" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig1" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11470_16025_40886_en_f111470i_copia_copy1.jpg" "Alto" => 689 "Ancho" => 1015 "Tamanyo" => 240142 ] ] "descripcion" => array:1 [ "en" => "Patients included in the study categorised by hospital" ] ] ] "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">INTRODUCTION AND OBJECTIVE</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">Cytomegalovirus (CMV) continues to represent one of the most important opportunistic pathogens due to its frequency in kidney transplant patients, causing both direct complications (acute viral syndrome, invasive syndrome) and indirect complications (opportunistic infections, graft rejection, cardiovascular damage, etc.).<span class="elsevierStyleSup">1,2</span> Currently, two different strategies are commonly used to prevent this disease in adult patients: prophylaxis, which is administered during the first 3-6 months following transplant primarily in high-risk patients (donor+/recipient – [D+/R-]), or preemptive therapy, which is commenced as soon as viraemia is detected through periodical laboratory tests. Prolonging prophylactic treatment to 6 months appears to reduce the incidence of late onset disease,<span class="elsevierStyleSup">3</span> although there is no clear consensus regarding its use due to the development of possible anti-viral resistance, drug toxicity, reduced compliance, and increased cost, among others.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">Although adult and paediatric patients share similar risk factors for developing post-transplant CMV disease, the paediatric patient has a higher frequency of high-risk patients given the greater proportion of recipients with negative CMV serology to seropositive donors, and as such, a greater probability of primary viral infection.<span class="elsevierStyleSup">4,5</span> Despite this situation, very few studies have been carried out in children, and management strategies are for the most part based on results from the adult population.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">In general, the most commonly used strategy in modern paediatric kidney transplants is a mix of the two strategies proposed for adult recipients: a relatively short prophylactic period followed by monitoring viral load in order to provide preemptive treatment in the case of positive viraemia.<span class="elsevierStyleSup">5,6</span> Although several studies have reported a reduction in the prevalence of CMV disease to only 4% in one cohort of paediatric recipients of kidney transplants, including a 50% reduction in high-risk patients as compared to those who did not receive prophylaxis,<span class="elsevierStyleSup">7</span> multi-centre trials with a prospective and randomised study design are needed to firmly establish which strategy to follow, the appropriate duration of prophylactic treatment, and/or monitoring for preventing disease in these patients.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">After committing to participate in a trial of these characteristics, we decided to first compile information regarding the situation of kidney transplants in paediatric patients in Spain, what proportion of these are high risk, the incidence of disease/infection by CMV, and the current state of clinical practice regarding prophylaxis/preemptive therapy.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">MATERIAL AND METHOD</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">We performed a retrospective observational study using data extracted from clinical histories and databases at each of the different participating hospitals, referencing the variables summarised in Table 1. This involved 5 of the 7 paediatric nephrology units where virtually all paediatric kidney transplants in Spain are performed, with the distribution displayed in Figure 1. The studied population included all paediatric patients who received transplants at these 5 centres during a 5-year study period (1 January 2005 to 31 December 2009). We compiled data from each of these patients collected during the first year following transplantation. We included all patients in our study that surpassed 6 months with a functioning renal graft.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">Definitions: Infection</span> was defined as a detection of antigenaemia (pp65 CMV in leukocytes) or a positive polymerase chain reaction (PCR) test for CMV, and we considered <span class="elsevierStyleBold">disease</span> to be present when the virus detection was supplemented by viral syndrome (fever >38º not produced by other causes, with at least leukopenia) with or without accompanying symptoms of specific organ involvement, and requiring anti-CMV treatment.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">We differentiated between <span class="elsevierStyleBold">primary</span> CMV, in patients who, prior to transplantation, had negative serology test results for CMV, and <span class="elsevierStyleBold">reactivation</span> of CMV, when prior serology tests were positive, with no differentiation between reactivation and reinfection, since the strain of CMV was not taken into account. We considered <span class="elsevierStyleBold">recurrent infection</span> to be a new detection of CMV at least 4 weeks after having controlled the first infection.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">We defined <span class="elsevierStyleBold">chemical prophylaxis</span> as the use of an anti-CMV agent in the absence of evidence of active infection as a means to prevent disease acquisition. We defined preemptive treatment as the use of anti-CMV medication early, in patients with asymptomatic replication of virus detected through periodical monitoring using PCR or antigenaemia tests. The defined value for positive replication was dependent on the experience at each institution, and was not evaluated in our study.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">In patients who received prophylaxis with valganciclovir, doses were adjusted to body surface area and renal function.<span class="elsevierStyleSup">8</span></p><p class="elsevierStylePara"><span class="elsevierStyleSup"> </span></p><p class="elsevierStylePara"><span class="elsevierStyleBold">Statistical analyses</span> were carried out using IBM SSPS<span class="elsevierStyleSup">®</span> Statistic software, version 19.0: for descriptive analyses of qualitative study variables, we used absolute and relative frequencies and compared study groups using chi-square or Fischer’s exact tests as appropriate. The variable “age” did not follow a normal distribution, and so we summarised values as median [P25-P75] (interquartile range), and compared medians using the non-parametric Mann-Whitney U test. The level of statistical significance was set at <span class="elsevierStyleItalic">P</span><.05.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">RESULTS</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">We compiled the results from 257 patients who had received renal transplants during the study period, with no distinction made between living or cadaveric donor. Patient age ranged between 6 months and 19 years, and 160 patients were males, 97 females.</p><p class="elsevierStylePara">Due to various reasons, 18 of these patients were excluded from the final analysis:</p><p class="elsevierStylePara">- Eight were excluded due to early graft loss, all of which occurred during the first 72 hours either due to thrombosis (n=7) or vascular complications related to the surgical intervention (intra-operative loss due to vascular complication with uncontrollable bleeding).</p><p class="elsevierStylePara">The remaining 10 patients were excluded from our study due to an insufficiently long follow-up period. The reasons for this were: mycotic pseudoaneurysm in one patient necessitating a transplantectomy one month after transplantation; 5 cases of graft rejection (one case of hyperacute rejection, one case of acute rejection in a hyper-immunised patient four days after transplantation, one case of kidney rupture one week after transplantation due to severe cellular rejection, and two cases of acute humoral rejection due to major histocompatibility complex class I antigen A antibodies (anti-MHCA) after 10 and 15 days, respectively); 3 patients died due to infections (one due to septic shock of an unknown cause 19 days after transplantation, one due to infection after 3 months in the form of cerebral aspergillosis, and one due to multi-organ failure following an adenovirus infection 5.5 months after liver and kidney transplant); the last case excluded was due to a loss of follow-up after 5 months when the patient left the country.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">Our analysis involved the remaining 239 patients, which were composed of 147 males and 92 females and had a median age of 11.92 years (range: 0.5-19 years), with a standard deviation of 5.3 years.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">In four of these patients, both kidney and liver transplants were performed.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">The <span class="elsevierStyleBold">CMV status</span> for the study patients was the following: 129 recipients (54%) and 83 donors (34.7%) had negative serological test results for CMV, and 110 recipients (46.%) and 122 donors (51%) were seropositive, with the status of the remaining 34 donors (14.2%) unknown. In terms of donor/recipient (D/R) pairs, 60 of these (25.1%) were considered to be at a high risk of CMV infection due to a situation of D+/R-, and 57 pairs (23.8%) were not considered to be at risk due to D-/R- status (Table 2).</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">CMV management</span> was different at each different hospital:</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">In 19.2% of recipients, only preemptive treatment was provided, with no anti-CMV prophylaxis. Prophylaxis was administered in the remaining 80.8% of cases (193 recipients) during a mean time of 65.5 days (range: 7-180 days; standard deviation: 50 days). Only 12 patients (5%) received prolonged prophylaxis for a 6-month period. All patients considered to be at high risk received chemical prophylaxis.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">After prophylaxis was finalised, preemptive treatment was continued in these patients during the first 6 months post-transplantation.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">The most commonly used medication was intravenous (i.v.) ganciclovir, which was administered in 66.3% of all recipients who received prophylaxis (n=128) and was the only form of treatment (during a mean time of 10 days) in 36.8% of these patients (n=71); this was followed sequentially by oral valganciclovir (57.5% of patients after treatment with i.v. ganciclovir) (Figure 2). In 5.7% of cases (n=11), prophylaxis was administered in the form of i.v. gammaglobulin for 10 days, followed by oral aciclovir for another 80 days.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">Immunosuppressant treatment</span> was administered in the form of induction therapy with antiCD-25 in 75.3% of cases (n=180), thymoglobulin in 23.8% (n=57), and monoclonal antibodies against mature lymphocyte CD-3 complex (OKT-3) was used in one patient. The majority of patients (98.3%) underwent quadruple therapy with an anti-calcineurin drug (96% tacrolimus [n=230] and 4% cyclosporine), mycophenolate mofetil (100% of patients), and prednisone (98.7%). We did not observe a significant correlation between any of these treatments and the incidence of CMV.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">The <span class="elsevierStyleBold">diagnosis of CMV</span> was made using antigenaemia tests in 34.3% of cases and PCR in 36%, with no record of the method used in the remaining 29.7%. The periodicity of these tests was a mean 15 days during the first 2 months following transplantation, every 3 weeks during the third and fourth month following transplantation, and every month thereafter.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">Cytomegalovirus infection and disease</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">CMV tests were positive at some point during patient evolution in 58 cases (24.26%). Of these, 42 were only diagnosed with infection, and the remaining 16 (6.7%) were diagnosed with CMV disease. The mean time period between transplantation and positive CMV test results was 92.5 days, with a range of 20-310 days (standard deviation: 73.6 days), and always occurred after prophylaxis was finished.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">- In 27 patients, the CMV infection was a primary infection, and 23 of these (85.2%) were high risk pairs (D+/R-), 2 were D-/R-, and the remaining two were D unknown/R-; this relationship was statistically significant (<span class="elsevierStyleItalic">P</span><.001) (Table 2). All of these patients had received prophylaxis against CMV: 14 with i.v. ganciclovir for a mean 13 days (10-14 days), with positive CMV tests results appearing a mean 65 days after transplantation; 5 received prophylaxis with oral valganciclovir for a mean 130 days (range: 90-180 days), with positive results in CMV tests a mean 169 days after transplantation; 6 were treated with both: i.v. ganciclovir followed by oral valganciclovir until reaching 100 total days of treatment; the remaining two patients were treated with specific gammaglobulin for 10 days followed by oral aciclovir until reaching a total treatment time of 80 days.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">- Of the 31 remaining cases that were considered to be reactivations of disease, 21 had received some type of prophylaxis: 12 with i.v. ganciclovir for 10 days, 8 with oral valganciclovir for a mean 72 days (range: 14-90 days), and one with specific gammaglobulin (10 doses) followed by aciclovir until reaching 2 months of treatment.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">- Of the 16 patients who had CMV disease, 13 had received prophylaxis, 6 of these for a duration of time shorter than 20 days and with i.v. ganciclovir, 6 received oral valganciclovir for 100 days, and 1 received gammaglobulin for 10 days followed by aciclovir until reaching a total of 60 days of treatment. The remaining 3 patients received preemptive treatment. In 9 patients, the CMV infection was a primary infection, and the remaining 7 were considered reinfections. As regards symptoms, 7 patients developed viral syndrome, 2 had probable gastrointestinal disease, and the remaining 7 were not evaluated. Four of the patients with CMV disease had required increased immunosuppression therapy prior to disease onset: 3 due to acute graft rejection (2 received steroid boluses and 1 received steroid boluses and thymoglobulin) and 1 due to recurrent post-transplant vasculitis (steroid boluses and cyclophosphamide). Another 2 patients with CMV disease had been diagnosed with post-transplant <span class="elsevierStyleItalic">de novo</span> diabetes prior to disease onset. We observed no relationship between graft rejection and CMV disease (<span class="elsevierStyleItalic">P</span>=.15), or between diabetic state and disease (<span class="elsevierStyleItalic">P</span>=.085).</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">All the cases of CMV disease were treated with i.v. ganciclovir with good evolution.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">- Six patients had recurring infections: 5 of these had received prophylaxis with i.v. ganciclovir for less than 20 days, and the sixth had received preemptive treatment. None of these patients had experienced episodes of rejection, diabetes, or intensified immunosuppression therapy.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">- We did not observe a significant relationship between having received prophylactic treatment and the appearance of CMV (<span class="elsevierStyleItalic">P</span>=.656) or CMV disease (<span class="elsevierStyleItalic">P</span>=.95), but there was a correlation between the application of prophylactic treatment for less than 20 days post-transplantation (<span class="elsevierStyleItalic">P</span><.05) and with the sole use of i.v. ganciclovir in prophylactic therapy (<span class="elsevierStyleItalic">P</span><.05).</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">Acute rejection/diabetes</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">Thirty-two patients (13.4% of the total study sample) had at least one episode of acute rejection, and six of these suffered a second episode as well. Eleven of these (34.3%) also developed CMV infection or disease: in four of these, the CMV infection occurred prior to rejection (3 high risk D+/R- and 1 D+/R+), and in the other seven, CMV appeared after rejection. In these cases, the patients had received anti-rejection treatment: 3 steroid boluses in four patients, 7 doses of thymoglobulin in 1 patient, and both types of treatment in succession in 2 patients.</p><p class="elsevierStylePara">Nine patients were diagnosed with post-transplant <span class="elsevierStyleItalic">de novo</span> diabetes during the first year of follow-up; the diagnosis was made a mean 34.3 days after the intervention. Four of these cases also involved the appearance of positive test results for CMV, all of which occurred after the onset of diabetes.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">We also failed to observe a significant relationship between acute rejection and CMV infection, the use of thymoglobulin, or diabetes.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">We did not observe any cases of resistance, lymphoproliferative disease, or graft losses due to CMV infection.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">DISCUSSION</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">We believe that our study provides a major contribution to this field of medicine due to the large number of paediatric patients evaluated as compared to other studies. In recent years, not even the data from the North American Paediatric Renal Trials and Collaborative Studies (NAPRTCS)<span class="elsevierStyleSup">9</span> have specified the incidence of CMV, and the article by this group regarding CMV prophylaxis, upon which many later studies have been based, dates back to 1997 and only involved hospitalised patients.<span class="elsevierStyleSup">10</span> In addition, our study truly reflects the situation of these patients in Spain due to our inclusion of 5 different paediatric nephrology units out of the 7 currently active in the field of paediatric renal transplants (these institutions carry out virtually all of such operations). Even so, we recognise that there is a certain loss of validity due to the fact that this was a retrospective study performed on a range of data derived from different centres that utilise different strategies and attitudes when dealing with CMV, the focus of our study.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">In the few studies carried out among paediatric patients that have been published in the medical literature in recent years, the number of recipients with negative CMV serology test results at the moment of transplantation varies from approximately 55%<span class="elsevierStyleSup">11,12</span> to values as high as 87%.<span class="elsevierStyleSup">13</span> In our study, 54% of patients were CMV negative. This percentage among paediatric patients was much higher than in studies concerning adult patients (as expected), which range between 11%<span class="elsevierStyleSup">14</span> and 29%.<span class="elsevierStyleSup">15</span></p><p class="elsevierStylePara"><span class="elsevierStyleSup"> </span></p><p class="elsevierStylePara">As regards the prevalence of high-risk recipients (D+/R-), which constituted 26% of all patients in our study, this rate is slightly lower than the rates published in other paediatric studies, which range between 27.2%<span class="elsevierStyleSup">11</span> and 42%.<span class="elsevierStyleSup">13</span> However, the percentage of low-risk recipients (D-/R-) in our study was 24%, a mid-range value when compared to rates reported in previous studies (12%<span class="elsevierStyleSup">10</span> to 45%<span class="elsevierStyleSup">11</span>).</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">The threshold value of antigenaemia or DNA-aemia for considering there to be a CMV infection and require preventative treatment was not evaluated, given the impossibility of super-imposing the results obtained from the different centres due to the wide range of methods used for diagnosis, as has already been mentioned.<span class="elsevierStyleSup">16,17</span> The periodicity of measurements, although determined according to the protocol at each unit, was quite similar across the different hospitals. It is not difficult to perform this type of monitoring of paediatric patients, who generally are evaluated frequently and at the same centre where the transplant was performed.</p><p class="elsevierStylePara">We also did not differentiate between reinfection and reactivation in the case of patients with positive CMV serological test results prior to transplantation and later detection of CMV, since the virus strain was not defined.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">The incidence of CMV infection/disease in our patients during the first year following transplantation was 24.26% (58 cases out of the 239 transplants evaluated), which is lower than the incidence rate reported by other paediatric groups (Table 3).<span class="elsevierStyleSup">11-13,18,19</span> It is difficult to draw conclusions regarding which factors influence this incidence rate, given the variety of different strategies used to treat paediatric patients with CMV, not only in the different studies published, but even between patients in a single study. In this manner, the incidence rate decreases to 13% in small cohorts of paediatric patients that exclude low-risk individuals and provide prophylactic treatment to all individuals.<span class="elsevierStyleSup">18</span> In our study, we believe that the low incidence of CMV disease was due to the fact that all patients either received prophylactic treatment or preemptive treatment, with preemptive therapy even commencing after chemical prophylaxis was finalised.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">It has been shown both in adults<span class="elsevierStyleSup">4,14,16</span> and the paediatric population<span class="elsevierStyleSup">11,12</span> –and we have again confirmed this in our study- that the incidence of CMV is greater in high-risk recipients, as well as the fact that positive donor serological test results are an independent risk factor for CMV infection.<span class="elsevierStyleSup">11,12</span> We have also shown that perhaps (this should be a focus of future studies) the use of prophylaxis would benefit recipients of organs from positive donors, regardless of the serology of the recipient. On the other hand, we did not observe a relationship between the use of prophylaxis and CMV infection, perhaps due to the large number of patients that received this type of treatment, except for cases where prophylaxis was kept for less than 20 days. This coincides with the significant relationship observed between prophylaxis with i.v. ganciclovir as a sole medication and only used during the first two weeks, with a 35.2% incidence rate of CMV within the group of patients who received prophylaxis (<span class="elsevierStyleItalic">P</span>.05). This incidence, which is greater than the general incidence of CMV in the overall study population, is close to the upper range of CMV rates (52.4%) reported in other studies in which patients received i.v. ganciclovir as the sole form of prophylaxis.<span class="elsevierStyleSup">20</span> This significance may not be related so much to the medication used, but is more probably related to the early use of prophylaxis and its short duration. In fact, studies have already reported evidence that supports delaying the start of prophylaxis until after the second week post-transplantation in order to allow for the specific immunity of the recipient to develop.<span class="elsevierStyleSup">21</span></p><p class="elsevierStylePara"><span class="elsevierStyleSup"> </span></p><p class="elsevierStylePara">To conclude, the current prevention strategy for CMV disease in paediatric recipients of renal transplants, whether through preemptive treatment or prophylaxis, maintains the incidence rate of this type of infection at similar values to those reported from other groups working with paediatric patients, without producing graft loss or severe disease during the first year following transplantation, although there is a greater incidence of infection when prophylaxis is administered for less than 3 weeks. We should evaluate whether extending the duration of prophylactic treatment to 6 months might improve these results, and the influence of this strategy on late indirect effects.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflicts of interest</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">The authors declare that they have no conflicts of interest related to the contents of this article.</p><p class="elsevierStylePara"><span class="elsevierStyleBold"> </span></p><p class="elsevierStylePara"><span class="elsevierStyleBold"> </span></p><p class="elsevierStylePara"><span class="elsevierStyleBold">KEY CONCEPTS</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">1.    Approximately 54% of the paediatric population that receives a renal transplant in Spain does not have pre-transplant antibodies against CMV.</p><p class="elsevierStylePara">2.    The mean incidence of CMV infection in cases of paediatric renal transplants in Spain is 24%, with an incidence of disease of approximately 7%.</p><p class="elsevierStylePara">3.    CMV is associated with the situation of D+/R- (high-risk recipient) (<span class="elsevierStyleItalic">P</span><.001) and with positive serology tests results in the kidney donor (<span class="elsevierStyleItalic">P</span><.001) regardless of recipient status.</p><p class="elsevierStylePara">4.   25% of the population is at a high risk (D+/R-) for CMV infection after transplantation.</p><p class="elsevierStylePara">5.    Currently, the primary preventative strategy is chemical prophylaxis, with a mean duration of 65 days.</p><p class="elsevierStylePara">6.    Graft loss or patient death due to this aetiology in the first year following transplantation are rare.</p><p class="elsevierStylePara"><a href="grande/11470_16025_40886_en_f111470i_copia_copy1.jpg" class="elsevierStyleCrossRefs"><img src="11470_16025_40886_en_f111470i_copia_copy1.jpg" alt="Patients included in the study categorised by hospital"></img></a></p><p class="elsevierStylePara">Figure 1. Patients included in the study categorised by hospital</p><p class="elsevierStylePara"><a href="grande/11470_16025_40889_en_f211470i_copia_copy1.jpg" class="elsevierStyleCrossRefs"><img src="11470_16025_40889_en_f211470i_copia_copy1.jpg" alt="Preventive treatment strategy"></img></a></p><p class="elsevierStylePara">Figure 2. Preventive treatment strategy</p><p class="elsevierStylePara"><a href="grande/11470_16025_40891_en_t111470i_copia.jpg" class="elsevierStyleCrossRefs"><img src="11470_16025_40891_en_t111470i_copia.jpg" alt="Studied variables"></img></a></p><p class="elsevierStylePara">Table 1. Studied variables</p><p class="elsevierStylePara"><a href="grande/11470_16025_40892_en_t211470i_copia.jpg" class="elsevierStyleCrossRefs"><img src="11470_16025_40892_en_t211470i_copia.jpg" alt="Incidence of cytomegalovirus according to donor/recipient serological status"></img></a></p><p class="elsevierStylePara">Table 2. Incidence of cytomegalovirus according to donor/recipient serological status</p><p class="elsevierStylePara"><a href="grande/11470_16025_40893_en_t311470i_copia.jpg" class="elsevierStyleCrossRefs"><img src="11470_16025_40893_en_t311470i_copia.jpg" alt="Comparison with other studies"></img></a></p><p class="elsevierStylePara">Table 3. Comparison with other studies</p>" "pdfFichero" => "P1-E547-S3855-A11470-EN.pdf" "tienePdf" => true "PalabrasClave" => array:2 [ "es" => array:2 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec436699" "palabras" => array:1 [ 0 => "Trasplante renal pediátrico" ] ] 1 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec436701" "palabras" => array:1 [ 0 => "Citomegalovirus" ] ] ] "en" => array:2 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec436700" "palabras" => array:1 [ 0 => "Paediatric renal transplant" ] ] 1 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec436702" "palabras" => array:1 [ 0 => "Cytomegalovirus" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:1 [ "resumen" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Objetivo</span><span class="elsevierStyleBold">:</span> Estudio retrospectivo observacional multicéntrico de los pacientes trasplantados renales pediátricos, para conocer la situación actual frente al citomegalovirus (CMV), antes de participar en un ensayo clínico internacional de profilaxis durante 6 meses. <span class="elsevierStyleBold">Material y métodos</span><span class="elsevierStyleBold">:</span> Se incluyen 239 pacientes menores de 19 años, procedentes de 5 centros entre 2005-2009, con seguimiento de 1 año. <span class="elsevierStyleBold">Resultados</span><span class="elsevierStyleBold">:</span> La serología frente al CMV era negativa en 54 % de los receptores y 34,7 % de los donantes. Sesenta pacientes (25,1 %) fueron considerados de alto riesgo [Donante (D)+/Receptor (R)-] para infección por CMV. El 80,8 % realizó algún tipo de profilaxis, incluyendo todos los pacientes de alto riesgo, un tiempo medio de 65,5 días. La incidencia de positivización de CMV fue del 24,26 % (58 pacientes de los 239 trasplantados), con una incidencia de enfermedad del 6,7 %. La infección por CMV se asociaba con el estatus serológico (D/R) (p < 0,001), con la seropositividad del donante (p < 0,001) y con un tiempo de profilaxis < 20 días (p < 0,05). No hubo ningún caso de éxitus o pérdida del injerto secundaria a la infección, ni de resistencia al tratamiento. <span class="elsevierStyleBold">Conclusiones</span><span class="elsevierStyleBold">:</span> La principal estrategia preventiva frente al CMV en el trasplante renal pediátrico en nuestro país es la quimioprofilaxis (81 %), con una incidencia de CMV del 24 % y de enfermedad del 6,7%, sin graves efectos directos ni indirectos en el primer año postrasplante. Su incidencia está relacionada, fundamentalmente, con el estatus serológico D/R y con la seropositividad del donante. </p>" ] "en" => array:1 [ "resumen" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Objective:</span> An observational retrospective multicentre study of kidney transplants in paediatric patients was performed to evaluate the current situation of cytomegalovirus (CMV) in this population, before our participation in an international clinical trial of prophylaxis for 6 months. <span class="elsevierStyleBold">Material and method:</span> Our study included 239 patients aged <19 years, from 5 Spanish centres between 2005-2009, with 1 year of follow-up. <span class="elsevierStyleBold">Results:</span> Pretransplant CMV serology was negative in 54% of recipients and 34.7% of donors. Sixty patients (25.1%) were considered at high risk (D+/R-) for CMV infection. Prophylaxis was used in 80.8% of recipients, including all high-risk patients, for an average time of 65.5 days. CMV viraemia occurred in 24.26% (58 cases among 239 patients), and disease in 6.7%. CMV infection was associated with serological status (D/R) (P<.001), positive serology of the donor (P<.001) and duration of prophylaxis <20 days (P<.05). There were no cases of patient or graft loss secondary to infection, nor resistance to treatment. <span class="elsevierStyleBold">Conclusions:</span> The main preventative strategy against CMV in paediatric renal transplantation in our country is chemical prophylaxis (81%), with an incidence of infection and disease of 24% and 6.7%, respectively. There were no serious direct or indirect effects in the first year post-transplant. The incidence is mainly linked with serological D/R and positive donor status.</p> <p class="elsevierStylePara"><span class="elsevierStyleItalic"> </span></p>" ] ] "multimedia" => array:5 [ 0 => array:8 [ "identificador" => "fig1" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11470_16025_40886_en_f111470i_copia_copy1.jpg" "Alto" => 689 "Ancho" => 1015 "Tamanyo" => 240142 ] ] "descripcion" => array:1 [ "en" => "Patients included in the study categorised by hospital" ] ] 1 => array:8 [ "identificador" => "fig2" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11470_16025_40889_en_f211470i_copia_copy1.jpg" "Alto" => 767 "Ancho" => 1015 "Tamanyo" => 208753 ] ] "descripcion" => array:1 [ "en" => "Preventive treatment strategy" ] ] 2 => array:8 [ "identificador" => "fig3" "etiqueta" => "Tab. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11470_16025_40891_en_t111470i_copia.jpg" "Alto" => 1284 "Ancho" => 1050 "Tamanyo" => 583406 ] ] "descripcion" => array:1 [ "en" => "Studied variables" ] ] 3 => array:8 [ "identificador" => "fig4" "etiqueta" => "Tab. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11470_16025_40892_en_t211470i_copia.jpg" "Alto" => 475 "Ancho" => 2151 "Tamanyo" => 312032 ] ] "descripcion" => array:1 [ "en" => "Incidence of cytomegalovirus according to donor/recipient serological status" ] ] 4 => array:8 [ "identificador" => "fig5" "etiqueta" => "Tab. 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11470_16025_40893_en_t311470i_copia.jpg" "Alto" => 515 "Ancho" => 2164 "Tamanyo" => 313242 ] ] "descripcion" => array:1 [ "en" => "Comparison with other studies" ] ] ] "bibliografia" => array:2 [ "titulo" => "Bibliography" "seccion" => array:1 [ 0 => array:1 [ "bibliografiaReferencia" => array:21 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "Pérez-Sola MJ, Castón JJ, Solana R, Rivero A, Torre-Cisneros J. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 9 | 13 | 22 |
| 2024 October | 41 | 49 | 90 |
| 2024 September | 47 | 42 | 89 |
| 2024 August | 57 | 73 | 130 |
| 2024 July | 47 | 32 | 79 |
| 2024 June | 62 | 41 | 103 |
| 2024 May | 68 | 39 | 107 |
| 2024 April | 54 | 51 | 105 |
| 2024 March | 38 | 26 | 64 |
| 2024 February | 30 | 43 | 73 |
| 2024 January | 42 | 27 | 69 |
| 2023 December | 43 | 25 | 68 |
| 2023 November | 46 | 31 | 77 |
| 2023 October | 43 | 38 | 81 |
| 2023 September | 38 | 33 | 71 |
| 2023 August | 40 | 21 | 61 |
| 2023 July | 64 | 23 | 87 |
| 2023 June | 43 | 27 | 70 |
| 2023 May | 59 | 26 | 85 |
| 2023 April | 48 | 25 | 73 |
| 2023 March | 83 | 36 | 119 |
| 2023 February | 55 | 26 | 81 |
| 2023 January | 44 | 20 | 64 |
| 2022 December | 56 | 46 | 102 |
| 2022 November | 64 | 39 | 103 |
| 2022 October | 58 | 48 | 106 |
| 2022 September | 41 | 33 | 74 |
| 2022 August | 53 | 49 | 102 |
| 2022 July | 33 | 44 | 77 |
| 2022 June | 47 | 33 | 80 |
| 2022 May | 38 | 32 | 70 |
| 2022 April | 59 | 51 | 110 |
| 2022 March | 72 | 45 | 117 |
| 2022 February | 80 | 44 | 124 |
| 2022 January | 77 | 40 | 117 |
| 2021 December | 55 | 42 | 97 |
| 2021 November | 43 | 31 | 74 |
| 2021 October | 60 | 59 | 119 |
| 2021 September | 37 | 46 | 83 |
| 2021 August | 29 | 35 | 64 |
| 2021 July | 65 | 50 | 115 |
| 2021 June | 49 | 35 | 84 |
| 2021 May | 43 | 41 | 84 |
| 2021 April | 95 | 49 | 144 |
| 2021 March | 70 | 48 | 118 |
| 2021 February | 77 | 22 | 99 |
| 2021 January | 55 | 29 | 84 |
| 2020 December | 51 | 20 | 71 |
| 2020 November | 53 | 16 | 69 |
| 2020 October | 42 | 17 | 59 |
| 2020 September | 60 | 8 | 68 |
| 2020 August | 52 | 13 | 65 |
| 2020 July | 42 | 15 | 57 |
| 2020 June | 43 | 21 | 64 |
| 2020 May | 71 | 19 | 90 |
| 2020 April | 32 | 11 | 43 |
| 2020 March | 41 | 20 | 61 |
| 2020 February | 52 | 19 | 71 |
| 2020 January | 59 | 33 | 92 |
| 2019 December | 47 | 23 | 70 |
| 2019 November | 50 | 22 | 72 |
| 2019 October | 27 | 14 | 41 |
| 2019 September | 37 | 19 | 56 |
| 2019 August | 29 | 15 | 44 |
| 2019 July | 29 | 20 | 49 |
| 2019 June | 37 | 23 | 60 |
| 2019 May | 60 | 32 | 92 |
| 2019 April | 92 | 25 | 117 |
| 2019 March | 41 | 23 | 64 |
| 2019 February | 43 | 25 | 68 |
| 2019 January | 46 | 25 | 71 |
| 2018 December | 114 | 42 | 156 |
| 2018 November | 151 | 26 | 177 |
| 2018 October | 90 | 18 | 108 |
| 2018 September | 86 | 14 | 100 |
| 2018 August | 53 | 25 | 78 |
| 2018 July | 48 | 14 | 62 |
| 2018 June | 80 | 26 | 106 |
| 2018 May | 73 | 19 | 92 |
| 2018 April | 75 | 9 | 84 |
| 2018 March | 91 | 18 | 109 |
| 2018 February | 55 | 10 | 65 |
| 2018 January | 51 | 10 | 61 |
| 2017 December | 73 | 16 | 89 |
| 2017 November | 63 | 15 | 78 |
| 2017 October | 50 | 10 | 60 |
| 2017 September | 64 | 16 | 80 |
| 2017 August | 50 | 15 | 65 |
| 2017 July | 53 | 22 | 75 |
| 2017 June | 48 | 18 | 66 |
| 2017 May | 69 | 15 | 84 |
| 2017 April | 53 | 8 | 61 |
| 2017 March | 47 | 27 | 74 |
| 2017 February | 89 | 18 | 107 |
| 2017 January | 37 | 18 | 55 |
| 2016 December | 77 | 9 | 86 |
| 2016 November | 123 | 21 | 144 |
| 2016 October | 163 | 15 | 178 |
| 2016 September | 285 | 9 | 294 |
| 2016 August | 249 | 5 | 254 |
| 2016 July | 270 | 16 | 286 |
| 2016 June | 158 | 0 | 158 |
| 2016 May | 175 | 0 | 175 |
| 2016 April | 145 | 0 | 145 |
| 2016 March | 117 | 0 | 117 |
| 2016 February | 156 | 0 | 156 |
| 2016 January | 146 | 0 | 146 |
| 2015 December | 164 | 0 | 164 |
| 2015 November | 121 | 0 | 121 |
| 2015 October | 113 | 0 | 113 |
| 2015 September | 94 | 0 | 94 |
| 2015 August | 88 | 0 | 88 |
| 2015 July | 94 | 0 | 94 |
| 2015 June | 57 | 0 | 57 |
| 2015 May | 51 | 0 | 51 |
| 2015 April | 15 | 0 | 15 |
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