TY - JOUR
T1 - Impact of prophylaxis with CytoGam alone on the incidence of CMV viremia in CMV-seropositive lung transplant recipients
AU - Kruger, Robert M.
AU - Paranjothi, Subramanian
AU - Storch, Gregory A.
AU - Lynch, John P.
AU - Trulock, Elbert P.
N1 - Funding Information:
This study was supported by a grant from MedImmune, Inc.
PY - 2003/7/1
Y1 - 2003/7/1
N2 - Background: Cytomegalovirus (CMV) infection remains a serious problem after lung transplantation. The purpose of this study was to evaluate the efficacy of CytoGam, a CMV hyperimmune globulin (CMV-IGIV), as CMV prophylaxis after lung transplantation. Methods: This prospective, randomized, open-label study compared prophylaxis with CMV-IGIV and no prophylaxis in 44 CMV-seropositive lung transplant recipients. The primary end-point was development of CMV viremia during the first year after transplantation. Results: Cytomegalovirus viremia was detected in 13 of 22 recipients without prophylaxis and in 16 of 22 recipients with CMV-IGIV prophylaxis (p = 0.19). Cytomegalovirus pneumonitis developed in 8 controls vs in 11 CMV-IGIV recipients (p = 0.54). We found no significant difference between the groups in the incidence of positive shell vial assays (6.8% ± 6.5% without vs 11.2% ± 10.1% with prophylaxis, p = 0.09) or in the attack rate of CMV pneumonitis (0.41 ± 0.59 episodes/patient without vs 0.86 ± 0.99 episodes/patient with prophylaxis, p = 0.07). Similarly, no difference was apparent in the time to onset of CMV viremia, to detection of CMV DNA in peripheral blood leukocytes by polymerase chain reaction, or to development of CMV pneumonitis. The incidence of acute rejection and bronchiolitis obliterans syndrome and the survival rate during the first post-transplant year did not differ between the groups. Conclusions: Prophylaxis with CMV-IGIV alone did not decrease CMV viremia or pneumonitis, did not decrease the incidence of acute rejection or bronchiolitis obliterans syndrome, and did not affect 1-year survival of CMV-seropositive lung transplant recipients at our center.
AB - Background: Cytomegalovirus (CMV) infection remains a serious problem after lung transplantation. The purpose of this study was to evaluate the efficacy of CytoGam, a CMV hyperimmune globulin (CMV-IGIV), as CMV prophylaxis after lung transplantation. Methods: This prospective, randomized, open-label study compared prophylaxis with CMV-IGIV and no prophylaxis in 44 CMV-seropositive lung transplant recipients. The primary end-point was development of CMV viremia during the first year after transplantation. Results: Cytomegalovirus viremia was detected in 13 of 22 recipients without prophylaxis and in 16 of 22 recipients with CMV-IGIV prophylaxis (p = 0.19). Cytomegalovirus pneumonitis developed in 8 controls vs in 11 CMV-IGIV recipients (p = 0.54). We found no significant difference between the groups in the incidence of positive shell vial assays (6.8% ± 6.5% without vs 11.2% ± 10.1% with prophylaxis, p = 0.09) or in the attack rate of CMV pneumonitis (0.41 ± 0.59 episodes/patient without vs 0.86 ± 0.99 episodes/patient with prophylaxis, p = 0.07). Similarly, no difference was apparent in the time to onset of CMV viremia, to detection of CMV DNA in peripheral blood leukocytes by polymerase chain reaction, or to development of CMV pneumonitis. The incidence of acute rejection and bronchiolitis obliterans syndrome and the survival rate during the first post-transplant year did not differ between the groups. Conclusions: Prophylaxis with CMV-IGIV alone did not decrease CMV viremia or pneumonitis, did not decrease the incidence of acute rejection or bronchiolitis obliterans syndrome, and did not affect 1-year survival of CMV-seropositive lung transplant recipients at our center.
UR - http://www.scopus.com/inward/record.url?scp=0037489513&partnerID=8YFLogxK
U2 - 10.1016/S1053-2498(02)00648-4
DO - 10.1016/S1053-2498(02)00648-4
M3 - Article
C2 - 12873543
AN - SCOPUS:0037489513
SN - 1053-2498
VL - 22
SP - 754
EP - 763
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 7
ER -