TY - JOUR
T1 - Preemptive use of oral ganciclovir to prevent cytomegalovirus infection in liver transplant patients
T2 - A randomized, placebo-controlled trial
AU - Paya, Carlos V.
AU - Wilson, Jennie A.
AU - Espy, Mark J.
AU - Sia, Irene G.
AU - DeBernardi, Michael J.
AU - Smith, Thomas F.
AU - Patel, Robin
AU - Jenkins, Greg
AU - Harmsen, William S.
AU - Vanness, David J.
AU - Wiesner, Russell H.
N1 - Funding Information:
Received 14 August 2001; revised 26 November 2001; electronically published 19 March 2002. Informed consent was obtained from patients or their guardians. The human experimentation guidelines of the US Department of Health and Human Services and the Mayo Foundation Institutional Review Board were followed in conducting this study. Financial support: Roche Pharmaceuticals (research grant). Reprints or correspondence: Dr. Carlos V. Paya, Mayo Clinic, 200 First St. SW, Rochester, MN 55905 ([email protected]).
PY - 2002/4/1
Y1 - 2002/4/1
N2 - The use of postdetection antiviral treatment of cytomegalovirus (CMV) as a strategy to prevent infection and disease in solid-organ transplant patients has not been evaluated by placebo-controlled trials. We carried out such a study in 69 patients who had received liver transplants and had positive results of CMV polymerase chain reaction within 8 weeks after transplantation but did not have concomitant CMV infection or disease. These patients were randomly assigned to receive placebo or oral ganciclovir for 8 weeks. CMV infection developed in 21% and disease developed in 12% of placebo recipients (P = .022), compared with 3% and 0%, respectively, among ganciclovir recipients (P = .003). Similarly, in the placebo arm, 55% and 36% of CMV-negative patients who received organs from CMV-positive donors developed CMV infection or disease, respectively (P = .02), compared with 11% and 0% of such patients in the ganciclovir arm (P < .01). Oral ganciclovir administered on CMV detection by PCR prevents CMV infection or disease after liver transplantation.
AB - The use of postdetection antiviral treatment of cytomegalovirus (CMV) as a strategy to prevent infection and disease in solid-organ transplant patients has not been evaluated by placebo-controlled trials. We carried out such a study in 69 patients who had received liver transplants and had positive results of CMV polymerase chain reaction within 8 weeks after transplantation but did not have concomitant CMV infection or disease. These patients were randomly assigned to receive placebo or oral ganciclovir for 8 weeks. CMV infection developed in 21% and disease developed in 12% of placebo recipients (P = .022), compared with 3% and 0%, respectively, among ganciclovir recipients (P = .003). Similarly, in the placebo arm, 55% and 36% of CMV-negative patients who received organs from CMV-positive donors developed CMV infection or disease, respectively (P = .02), compared with 11% and 0% of such patients in the ganciclovir arm (P < .01). Oral ganciclovir administered on CMV detection by PCR prevents CMV infection or disease after liver transplantation.
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U2 - 10.1086/339449
DO - 10.1086/339449
M3 - Article
C2 - 11920308
AN - SCOPUS:0036535058
SN - 0022-1899
VL - 185
SP - 854
EP - 860
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 7
ER -
