%0 Journal Article %1 FinlenCopeland2011 %A Finlen Copeland, C Ashley %A Davis, W Austin %A Snyder, Laurie D. %A Banks, Missy %A Avery, Robin %A Davis, R Duane %A Palmer, Scott M. %D 2011 %J J Heart Lung Transplant %K cmv transplantation prophylaxis virus %N 9 %P 990--996 %R 10.1016/j.healun.2011.02.017 %T Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: a single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial. %U http://dx.doi.org/10.1016/j.healun.2011.02.017 %V 30 %X The optimal approach to cytomegalovirus (CMV) prevention after lung transplantation is controversial. We recently completed a prospective, randomized, placebo-controlled study of CMV prevention in lung transplantation that demonstrated the short-term efficacy and safety of extending valganciclovir prophylaxis to 12 months vs 3 months of therapy. In the current analysis, we monitored a single-center subset of patients enrolled in the CMV prevention trial to determine if extended prophylaxis conferred a sustained long-term benefit and to assess its hematologic safety.The sub-analysis included 38 randomized patients from Duke University Medical Center. All patients underwent consistent serial serum CMV monitoring and surveillance bronchoscopies. CMV was defined by viremia (≥ 500 CMV DNA copies/ml) or pneumonitis. The safety assessment included a review of all complete blood counts obtained from transplant onward.During a mean follow-up of 3.9 years in each group, extended-course compared with short-course prophylaxis provided a sustained protective benefit with a lifetime CMV incidence of 12\% vs 55\%, respectively (hazard ratio, 0.13; 95\% confidence interval, 0.03-0.61; p = 0.009), an effect that persisted after adjustment for clinical risk factors. Patients in each group underwent a comparable number of peripheral blood draws and bronchoscopies. Post-transplant white blood cell, neutrophil, and platelet counts were similar between each treatment group during the course of follow-up.Extending valganciclovir prophylaxis to 12 months provides a durable long-term CMV protective benefit compared with short-course therapy, without increasing adverse hematologic effects.

@article{FinlenCopeland2011, abstract = {The optimal approach to cytomegalovirus (CMV) prevention after lung transplantation is controversial. We recently completed a prospective, randomized, placebo-controlled study of CMV prevention in lung transplantation that demonstrated the short-term efficacy and safety of extending valganciclovir prophylaxis to 12 months vs 3 months of therapy. In the current analysis, we monitored a single-center subset of patients enrolled in the CMV prevention trial to determine if extended prophylaxis conferred a sustained long-term benefit and to assess its hematologic safety.The sub-analysis included 38 randomized patients from Duke University Medical Center. All patients underwent consistent serial serum CMV monitoring and surveillance bronchoscopies. CMV was defined by viremia (≥ 500 CMV DNA copies/ml) or pneumonitis. The safety assessment included a review of all complete blood counts obtained from transplant onward.During a mean follow-up of 3.9 years in each group, extended-course compared with short-course prophylaxis provided a sustained protective benefit with a lifetime CMV incidence of 12\% vs 55\%, respectively (hazard ratio, 0.13; 95\% confidence interval, 0.03-0.61; p = 0.009), an effect that persisted after adjustment for clinical risk factors. Patients in each group underwent a comparable number of peripheral blood draws and bronchoscopies. Post-transplant white blood cell, neutrophil, and platelet counts were similar between each treatment group during the course of follow-up.Extending valganciclovir prophylaxis to 12 months provides a durable long-term CMV protective benefit compared with short-course therapy, without increasing adverse hematologic effects.}, added-at = {2012-06-20T02:44:23.000+0200}, author = {{Finlen Copeland}, C Ashley and Davis, W Austin and Snyder, Laurie D. and Banks, Missy and Avery, Robin and Davis, R Duane and Palmer, Scott M.}, biburl = {https://www.bibsonomy.org/bibtex/276aef3394a9f911bc4b4e0fd36afb783/aorchid}, description = {Subcohort of the larger study. 19 LTR each in extended (12mos) vs. normal (3mos) valgcv prophy now looking at risk for CMV out to 18 mos. The extended prophylaxis decreased risk HR 0.15 (0.03-0.69, p=0.01). So far looks good.}, doi = {10.1016/j.healun.2011.02.017}, file = {longer cmv prophylaxis:ID_General/TransplantClinical/JHeartLungTransplant.30.990.pdf:PDF}, groups = {public}, institution = {Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710, USA.}, interhash = {c838c5181415873549527b72116225ef}, intrahash = {76aef3394a9f911bc4b4e0fd36afb783}, journal = {J Heart Lung Transplant}, keywords = {cmv transplantation prophylaxis virus}, language = {eng}, medline-pst = {ppublish}, month = Sep, number = 9, pages = {990--996}, pii = {S1053-2498(11)00832-1}, pmid = {21489817}, timestamp = {2012-06-20T02:44:23.000+0200}, title = {Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: a single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial.}, url = {http://dx.doi.org/10.1016/j.healun.2011.02.017}, username = {aorchid}, volume = 30, year = 2011 }