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
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.
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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Hematology/Oncology, Infectious Disease.
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