TY - JOUR
T1 - Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation
T2 - A single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial
AU - Finlen Copeland, C. Ashley
AU - Davis, W. Austin
AU - Snyder, Laurie D.
AU - Banks, Missy
AU - Avery, Robin
AU - Davis, R. Duane
AU - Palmer, Scott M.
N1 - Funding Information:
Scott M. Palmer is funded by National Heart Lung and Blood Institute SCCOR 1P50-HL084917–01 and K24–091140–01. Laurie D. Snyder is funded by National Institutes of Health KL2RR024127 and American Society of Transplantation Clinical Faculty Development Award.
Funding Information:
The original VALGAN randomized controlled trial was funded by Roche Pharmaceuticals as an investigator-initiated clinical trial, coordinated by the Duke Clinical Research Institute. All money was paid directly to the Duke Clinical Research Institute for clinical trial operating expenses. Roche did not assist with preparation, writing, or review of original trial manuscript. Roche provided no additional funding for this single center follow up analysis. Roche did not assist with the preparation, writing, or review of this manuscript.
PY - 2011/9
Y1 - 2011/9
N2 - Background: 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. Methods: 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. Results: 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, 0.030.61; 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. Conclusion: Extending valganciclovir prophylaxis to 12 months provides a durable long-term CMV protective benefit compared with short-course therapy, without increasing adverse hematologic effects.
AB - Background: 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. Methods: 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. Results: 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, 0.030.61; 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. Conclusion: Extending valganciclovir prophylaxis to 12 months provides a durable long-term CMV protective benefit compared with short-course therapy, without increasing adverse hematologic effects.
KW - bronchiolitis obliterans syndrome
KW - cytomegalovirus
KW - lung transplantation
KW - valganciclovir
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U2 - 10.1016/j.healun.2011.02.017
DO - 10.1016/j.healun.2011.02.017
M3 - Article
C2 - 21489817
AN - SCOPUS:80051469766
SN - 1053-2498
VL - 30
SP - 990
EP - 996
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 9
ER -