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A Randomized Study of Quantiferon CMV-directed Versus Fixed-duration Valganciclovir Prophylaxis to Reduce Late CMV After Lung Transplantation

Westall, Glen P., MD1; Cristiano, Yvonne, RN1; Levvey, Bronwyn J., RN1; Whitford, Helen, MD1; Paraskeva, Miranda A., MD1; Paul, Eldho, PhD2; Peleg, Anton Y., MD3; Snell, Gregory I., MD1

doi: 10.1097/TP.0000000000002454
Original Clinical Science—General
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Background. We provide the results of the first interventional study of cytomegalovirus (CMV)-specific immune monitoring to direct the length of antiviral prophylaxis in lung transplantation (LTx).

Methods. Patients (n = 118) at risk of CMV infection were randomized 1:2 to either 5 months or variable length valganciclovir prophylaxis (5–11 mo post-LTx), as determined by the QuantiFERON (QFN)-CMV assay. Patients with a negative QFN-CMV assay (< 0.2 IU/mL) received prolonged valganciclovir prophylaxis.

Results. The primary endpoint that was the incidence of CMV infection in the lung allograft within 18 months of LTx was significantly reduced in the QFN-CMV directed arm (37% versus 58%, P = 0.03). Secondary endpoints that included blood viremia, acute rejection, and chronic lung allograft dysfunction did not differ between the 2 arms. Of the 80/118 patients who ceased antiviral prophylaxis at 5 months, the incidence of viremia (> 600 copies/mL) within the blood was significantly reduced in patients with a positive QFN-CMV assay compared with those without protective immunity (13% versus 67%, P = 0.0003), as was the incidence of severe viremia (> 10 000 copies/mL) (3% versus 50%, P < 0.001). Ceasing antiviral prophylaxis at 11 months in patients with a negative assay was associated with a 25% incidence of late CMV viremia.

Conclusions. Cytomegalovirus immune monitoring allows an individualized approach to CMV prophylaxis and reduces late CMV infection within the lung allograft.

1 Lung Transplant Service, Alfred Health and Monash University, Melbourne, Australia.

2 Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.

3 Department of Infectious Diseases, Alfred Health and Monash University, Melbourne, Australia.

Received 10 July 2018. Revision received 29 August 2018.

Accepted 31 August 2018.

The QFN-CMV assays for the study were provided free-of-charge by Qiagen. G.W. received travel support from Qiagen to present the study abstract at the 2017 Transplantation Society of Australia and New Zealand (TSANZ) annual scientific meeting. There were no other disclosures or conflicts from the other authors.

The authors acknowledge the assistance of the Margaret Pratt Foundation for research nurse salary support.

G.W. participated in research design, performance of the research, data analysis and writing of the article. Y.C. participated in performance of the research, data analysis and writing of the article. B.L. participated in performance of the research and writing of the article. H.W. participated in performance of the research and writing of the article. M.P. participated in performance of the research and writing of the article. E.P. participated in data analysis and writing of the article. A.P. participated in research design and writing of the article. G.S. participated in research design, performance of the research and writing of the article.

Clinical Trial Notification: Australian Clinical Research Network: ACTRN12612000551897.

Correspondence: Glen P. Westall, MD, Lung Transplant Service, Alfred Health and Monash University, Commercial Road, Prahran, Melbourne, VIC 3181, Australia. (G.Westall@alfred.org.au).

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