Preemptive Use of Oral Ganciclovir to Prevent Cytomegalovirus Infection in Liver Transplant Patients: A Randomized, Placebo-Controlled Trial

• Published in: The Journal of infectious diseases 2002-04, Vol.185 (7), p.854-860
• Main Authors: Paya, Carlos V., Wilson, Jennie A., Espy, Mark J., Sia, Irene G., DeBernardi, Michael J., Smith, Thomas F., Patel, Robin, Jenkins, Greg, Harmsen, William S., Vanness, David J., Wiesner, Russell H.
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Aged; Antiviral Agents - administration & dosage; Antivirals; Biological and medical sciences; Cytomegalovirus; Cytomegalovirus - genetics; Cytomegalovirus - isolation & purification; Cytomegalovirus infections; Cytomegalovirus Infections - prevention & control; DNA, Viral - blood; Female; Ganciclovir - administration & dosage; Health care administration; Humans; Infections; Liver; Liver Transplantation - adverse effects; Liver, biliary tract, pancreas, portal circulation, spleen; Major Articles; Male; Medical sciences; Middle Aged; Placebos; Polymerase chain reaction; Polymerase Chain Reaction - methods; Preventive medicine; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the digestive system; Transplantation
• ISSN: 0022-1899; 1573-6613; 1537-6613
• DOI: 10.1086/339449

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.