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Ganciclovir Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Bone Marrow Transplant Recipients: Results of a Placebo-Controlled, Double-Blind Trial

Drew J. Winston, MD; Winston G. Ho, MD; Kathy Bartoni, RN; Charles Du Mond, PhD; Darlene F. Ebeling, MS; William C. Buhles, PhD; and Richard E. Champlin, MD
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From the UCLA Center for the Health Sciences, Los Angeles, California; the Institute of Clinical Medicine, Syntex Research, Palo Alto, California. Requests for Reprints: Drew J. Winston, MD, Room 42-121 CHS, Department of Medicine, UCLA Medical Center, Los Angeles, CA 90024. Acknowledgments: The authors thank Marjorie J. Miller, DPH, David A. Bruckner, ScD, and the staff of the UCLA Clinical Microbiology Laboratories for technical assistance; Bill Hirokawa, Ed Arriola, and the staff of the UCLA Pharmacy Services for administrative assistance; Margaret Frane for statistical assistance; Katharine Fry for preparation of the manuscript; and the nursing staffs who assisted in the care of these patients. The authors also thank Dr. Stephen Feig for his assistance and cooperation. Grant Support: By grant CA-23175 from the National Cancer Institute and by a research grant from Syntex Research.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1993;118(3):179-184. doi:10.7326/0003-4819-118-3-199302010-00004
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Objective: To evaluate the efficacy and safety of ganciclovir for prevention of cytomegalovirus (CMV) infection and disease.

Design: A randomized, placebo-controlled, double-blind trial.

Setting: University-affiliated bone marrow transplant center.

Patients: Cytomegalovirus-seropositive allogeneic bone marrow transplant recipients.

Interventions: Random assignment to receive either a placebo or ganciclovir at a dose of 2.5 mg/kg body weight every 8 hours for 1 week before transplant and then at a dose of 6 mg/kg once per day, Monday through Friday, after transplant when the post-transplant neutrophil count reached 1.0 × 109/L.

Measurements: Cytomegalovirus infection (positive culture, seroconversion, positive histologic findings), CMV disease (pneumonia, gastroenteritis, the wasting syndrome), and study-drug toxicity.

Results: Cytomegalovirus infection developed in 25 of 45 placebo patients (56%) but in only 8 of 40 ganciclovir patients (20%) (P < 0.001). Cytomegalovirus disease may also have occurred less often in the ganciclovir patients (4 of 40 patients [10%] versus 11 of 45 patients [24%]; P = 0.09). The probability of CMV disease occurring within the first 120 days after transplantation was 0.29 among the placebo patients but only 0.12 among ganciclovir patients (P = 0.06). Reversible neutropenia was the only appreciable toxicity related to ganciclovir and required interruption of the study drug after transplant in 25 of 43 ganciclovir patients (58%) and in 13 of 47 placebo patients (28%) (P = 0.005). Overall survival was similar in both the placebo patients (29 of 45 [64%]) and ganciclovir patients (28 of 40 [70%]; P > 0.2).

Conclusions: Prophylactic ganciclovir, started before transplant and continued after recovery of the post-transplant neutrophil count, reduces the incidence and severity of CMV infection in CMV-seropositive bone marrow transplant recipients but is frequently associated with neutropenia.


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Figure 1.
Probability of cytomegalovirus excretion during the first 120 days after transplantation.P

The difference in the probability of cytomegalovirus (CMV) excretion between placebo and ganciclovir patients has a value of 0.001. Kaplan-Meier product limit estimates.

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Grahic Jump Location
Figure 2.
Probability of cytomegalovirus disease during the first 120 days after transplantation.P

The difference in the probability of cytomegalovirus (CMV) disease between placebo and ganciclovir patients has a value of 0.06. Kaplan-Meier product limit estimates.

Grahic Jump Location




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