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. 2011 Sep;30(9):990-6. doi: 10.1016/j.healun.2011.02.017. Epub 2011 Apr 13.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Bronchoscopy
  • Cystic Fibrosis / surgery
  • Cytomegalovirus / isolation & purification
  • Cytomegalovirus Infections / prevention & control*
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Ganciclovir / adverse effects
  • Ganciclovir / analogs & derivatives*
  • Ganciclovir / therapeutic use
  • Humans
  • Longitudinal Studies
  • Lung / virology
  • Lung Diseases / diagnosis
  • Lung Diseases / prevention & control*
  • Lung Diseases / virology*
  • Lung Transplantation*
  • Male
  • Middle Aged
  • Pulmonary Disease, Chronic Obstructive / surgery
  • Pulmonary Fibrosis / surgery
  • Time Factors
  • Treatment Outcome
  • Valganciclovir

Substances

  • Antiviral Agents
  • Valganciclovir
  • Ganciclovir