Drew J. Winston, MD; Winston G. Ho, MD; Kathy Bartoni, RN; Charles Du Mond, PhD; Darlene F. Ebeling, MS; William C. Buhles, PhD; Richard E. Champlin, MD
To evaluate the efficacy and safety of ganciclovir for prevention of cytomegalovirus (CMV) infection and disease.
A randomized, placebo-controlled, double-blind trial.
University-affiliated bone marrow transplant center.
Cytomegalovirus-seropositive allogeneic bone marrow transplant recipients.
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.
Cytomegalovirus infection (positive culture, seroconversion, positive histologic findings), CMV disease (pneumonia, gastroenteritis, the wasting syndrome), and study-drug toxicity.
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).
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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Winston DJ, Ho WG, Bartoni K, Du Mond C, Ebeling DF, Buhles WC, et al. Ganciclovir Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Bone Marrow Transplant Recipients: Results of a Placebo-Controlled, Double-Blind Trial. Ann Intern Med. 1993;118:179–184. doi: 10.7326/0003-4819-118-3-199302010-00004
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Published: Ann Intern Med. 1993;118(3):179-184.
Hematology/Oncology, Infectious Disease.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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