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- Title
Ganciclovir prophylaxis of cytomegalovirus infection and disease in allogeneic bone marrow transplant recipients. Results of a placebo-controlled, double-blind trial.
- Authors
Winston, Drew J.; Ho, Winston G.; Bartoni, Kathy; Du Mond, Charles; Ebeling, Darlene F.; Buhles, William C.; Champlin, Richard E.; Winston, D J; Ho, W G; Bartoni, K; Du Mond, C; Ebeling, D F; Buhles, W C; Champlin, R E
- Abstract
<bold>Objective: </bold>To evaluate the efficacy and safety of ganciclovir for prevention of cytomegalovirus (CMV) infection and disease.<bold>Design: </bold>A randomized, placebo-controlled, double-blind trial.<bold>Setting: </bold>University-affiliated bone marrow transplant center.<bold>Patients: </bold>Cytomegalovirus-seropositive allogeneic bone marrow transplant recipients.<bold>Interventions: </bold>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 x 10(9)/L.<bold>Measurements: </bold>Cytomegalovirus infection (positive culture, seroconversion, positive histologic findings), CMV disease (pneumonia, gastroenteritis, the wasting syndrome), and study-drug toxicity.<bold>Results: </bold>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).<bold>Conclusions: </bold>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-sero-positive bone marrow transplant recipients but is frequently associated with neutropenia.
- Subjects
GANCICLOVIR; CYTOMEGALOVIRUS disease prevention; HERPESVIRUS diseases; CYTOMEGALOVIRUS disease diagnosis; OPPORTUNISTIC infection prevention; BONE marrow transplantation; CLINICAL trials; COMPARATIVE studies; CYTOMEGALOVIRUSES; HERPESVIRUSES; RESEARCH methodology; MEDICAL cooperation; NEUTROPENIA; RESEARCH; SERODIAGNOSIS; SURVIVAL; VIRAL physiology; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment; THERAPEUTICS
- Publication
Annals of Internal Medicine, 1993, Vol 118, Issue 3, p179
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-118-3-199302010-00004