Clinical transplantation proceedings
Use of combination cytomegalovirus immune globulin plus ganciclovir for prophylaxis in CMV-seronegative liver transplant recipients of a CMV-seropositive donor organ: a multicenter, open-label study

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Study population

Eligible patients included children and adults who underwent liver transplantation at the participating centers: New England Medical Center, Children’s Hospital, and Massachusetts General Hospital, Boston, Massachusetts; Cleveland Clinic Foundation, Cleveland, Ohio; and Emory University Hospital, Atlanta, Georgia. The study protocol was approved by the human investigation review committee of each institution.

Microbiologic and serologic studies, follow-up, and case definitions of

Results

There were 44 orthotopic liver transplant recipients presumed to be CMV-seronegative who received a CMV-seropositive donor organ and who were enrolled in the study from September 1993 to 1996. Five were dropped from analysis because the final CMV serologic status of the donor was negative, leaving 39 evaluable D+/R− patients. Of the 39 enrollees, 26% developed CMV disease, 15% developed tissue-invasive CMV disease, and 5% developed severe CMV-associated disease. The 1-year survival was 92% and

Discussion

We have shown that the use of intravenous ganciclovir for 2 weeks plus cytomegalovirus immune globulin over 4 months along with preemptive intravenous ganciclovir during treatment for rejection significantly reduces tissue-invasive CMV disease and severe CMV-associated disease in high-risk orthotopic liver transplant recipients who are CMV-seronegative and receive a CMV-seropositive donor organ. This difference persisted after controlling for renal function at transplant, volume of blood, and

Acknowledgements

This study was supported in part by an unrestricted grant from MedImmune, Inc. (Gaithersburg, Md, USA). The authors wish to thank Mrs Roselia Martinez for her assistance in putting the manuscript together. The authors want to acknowledge the assistance of Judy Brakeman, RN, Jeanne Grindlinger, RN. Monique Crowley, RN, and Maureen Doran, R.N.

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