Ganciclovir prophylaxis of cytomegalovirus infection and disease in allogeneic bone marrow transplant recipients: results of a placebo-controlled, double-blind trial
DJ Winston, WG Ho, K Bartoni, C Du Mond… - Annals of internal …, 1993 - acpjournals.org
Annals of internal medicine, 1993•acpjournals.org
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 …
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 …
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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