title: A trial of valganciclovir prophylaxis for cytomegalovirus prevention in lung transplant recipients.
abstract: Cytomegalovirus (CMV) infection is common after lung transplantation. We performed a prospective trial of valganciclovir prophylaxis in lung recipients with outcomes compared to matched historical controls. The valganciclovir group (n = 40) (including D+/R- and R+ patients) was prospectively enrolled, and received oral valganciclovir 900 mg once daily for 12 weeks. Historical controls (n = 40) received 12 weeks of daily intravenous ganciclovir if D+/R- or 12 weeks of oral ganciclovir if R+. CMV viral load testing was done at two-week intervals until 6 months posttransplant. Baseline demographics and immunosuppression were comparable in the two groups. The incidence of CMV viremia was 16/40 (40.0%) in the valganciclovir arm versus 18/40 (45%) in the ganciclovir arm (p = NS). The incidence of symptomatic CMV disease was 8/40 (20%) versus 7/40 (17.5%), respectively (p = NS). In both groups viremia, while on prophylaxis, was uncommon (valganciclovir: 0/40 and ganciclovir: 2/40). Peak viral load and time to viremia were similar in the two arms. High rates of viremia and symptomatic disease occurred in the D+/R- patients after discontinuation of prophylaxis. Genotypic CMV sequence analysis demonstrated low rates of ganciclovir resistance in both groups. Valganciclovir prophylaxis had similar efficacy to either intravenous ganciclovir (D+/R- patients), or oral ganciclovir (R+ patients) in lung recipients.
authors.affiliation: Department of Infectious Disease and Transplantation, University of Toronto, Ontario, Canada. Atul.Humar@uhn.on.ca
authors.forename: Atul
authors.initials: A
authors.lastname: Humar
authors.forename: Deepali
authors.initials: D
authors.lastname: Kumar
authors.forename: Jutta
authors.initials: J
authors.lastname: Preiksaitis
authors.forename: Guy
authors.initials: G
authors.lastname: Boivin
authors.forename: Deborah
authors.initials: D
authors.lastname: Siegal
authors.forename: Jayne
authors.initials: J
authors.lastname: Fenton
authors.forename: Kathy
authors.initials: K
authors.lastname: Jackson
authors.forename: Sarah
authors.initials: S
authors.lastname: Nia
authors.forename: Dale
authors.initials: D
authors.lastname: Lien
mesh_terms: D000284:Administration, Oral; D019072:Antibiotic Prophylaxis; D000998:Antiviral Agents / Q000627:therapeutic use*; D003587:Cytomegalovirus / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D024882:Drug Resistance, Viral; D005260:Female; D015774:Ganciclovir / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006085:Graft Survival; D006801:Humans; D016040:Lung Transplantation; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D000077562:Valganciclovir; D014766:Viremia / Q000517:prevention & control; D014779:Virus Replication
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir