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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.

Publication ,  Journal Article
Finlen Copeland, CA; Davis, WA; Snyder, LD; Banks, M; Avery, R; Davis, RD; Palmer, SM
Published in: J Heart Lung Transplant
September 2011

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, 0.03-0.61; 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. 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.

Duke Scholars

Published In

J Heart Lung Transplant

DOI

EISSN

1557-3117

Publication Date

September 2011

Volume

30

Issue

9

Start / End Page

990 / 996

Location

United States

Related Subject Headings

  • Valganciclovir
  • Treatment Outcome
  • Time Factors
  • Surgery
  • Pulmonary Fibrosis
  • Pulmonary Disease, Chronic Obstructive
  • Middle Aged
  • Male
  • Lung Transplantation
  • Lung Diseases
 

Citation

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Finlen Copeland, C. A., Davis, W. A., Snyder, L. D., Banks, M., Avery, R., Davis, R. D., & Palmer, S. M. (2011). 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. J Heart Lung Transplant, 30(9), 990–996. https://doi.org/10.1016/j.healun.2011.02.017
Finlen Copeland, C Ashley, W Austin Davis, Laurie D. Snyder, Missy Banks, Robin Avery, R Duane Davis, and Scott M. Palmer. “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.J Heart Lung Transplant 30, no. 9 (September 2011): 990–96. https://doi.org/10.1016/j.healun.2011.02.017.
Journal cover image

Published In

J Heart Lung Transplant

DOI

EISSN

1557-3117

Publication Date

September 2011

Volume

30

Issue

9

Start / End Page

990 / 996

Location

United States

Related Subject Headings

  • Valganciclovir
  • Treatment Outcome
  • Time Factors
  • Surgery
  • Pulmonary Fibrosis
  • Pulmonary Disease, Chronic Obstructive
  • Middle Aged
  • Male
  • Lung Transplantation
  • Lung Diseases