title: Efficacy and safety of low-dose valganciclovir in the prevention of cytomegalovirus disease in adult liver transplant recipients.
abstract: The efficacy and safety of valganciclovir (VGCV) for cytomegalovirus (CMV) prophylaxis in liver transplant recipients has not been established. We retrospectively compared the efficacy and safety of low-dose oral VGCV (450 mg once daily for 90 days) and standard oral ganciclovir (1 g three times a day for 90 days, GCV) in preventing CMV disease in 109 adult liver transplant recipients who survived at least 1 month between January 2001 and April 2003 (49 GCV and 60 VGCV). The incidence of CMV disease at 1 year post-transplant was similar among patients treated with VGCV and GCV (3% and 4%, respectively). Three of the four CMV disease cases occurred in high-risk recipients with CMV serotype of donor+/recipient- (D+/R-) and all cases presented after completion of CMV prophylaxis, ranging 114-152 days post-transplant. Severe neutropenia was rare, and thrombocytopenia and anemia occurred at similar frequencies with both prophylaxis regimens. In conclusion, a 90-day regimen of low-dose oral VGCV has a similar efficacy and safety profile to high-dose oral GCV in adult liver transplant recipients. D+/R- liver transplant recipients remain at risk of developing CMV disease after completion of antiviral prophylaxis. Additional prospective studies with close monitoring for CMV viremia and drug resistance are needed to further establish the optimal dose and duration of VGCV in liver transplant recipients.
authors.affiliation: College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA. jeongp@umich.edu
authors.forename: Jeong M
authors.initials: JM
authors.lastname: Park
authors.forename: Kathleen D
authors.initials: KD
authors.lastname: Lake
authors.forename: Juan D
authors.initials: JD
authors.lastname: Arenas
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Fontana
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage; D015331:Cohort Studies; D003586:Cytomegalovirus Infections / Q000188:drug therapy / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016031:Liver Transplantation / Q000009:adverse effects* / Q000276:immunology / Q000379:methods; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control* / Q000821:virology; D011322:Primary Prevention / Q000379:methods; D011336:Probability; D012189:Retrospective Studies; D018570:Risk Assessment; D014181:Transplantation Immunology / Q000187:drug effects; D016896:Treatment Outcome; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D000077562:Valganciclovir; D015774:Ganciclovir