title: Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients.
abstract: Intravenous ganciclovir is the standard treatment for cytomegalovirus disease in solid organ transplant recipients. Oral valganciclovir is a more convenient alternative. In a randomized, international trial, recipients with cytomegalovirus disease were treated with either 900 mg oral valganciclovir or 5 mg/kg i.v. ganciclovir twice daily for 21 days, followed by 900 mg daily valganciclovir for 28 days. A total of 321 patients were evaluated (valganciclovir [n = 164]; i.v. ganciclovir [n = 157]). The success rate of viremia eradication at Day 21 was 45.1% for valganciclovir and 48.4% for ganciclovir (95% CI -14.0% to +8.0%), and at Day 49; 67.1% and 70.1%, respectively (p = NS). Treatment success, as assessed by investigators, was 77.4% versus 80.3% at Day 21 and 85.4% versus 84.1% at Day 49 (p = NS). Baseline viral loads were not different between groups and decreased exponentially with similar half-lives and median time to eradication (21 vs. 19 days, p = 0.076). Side-effects and discontinuations of assigned treatment (18 of 321 patients) were comparable. Oral valganciclovir shows comparable safety and is not inferior to i.v. ganciclovir for treatment of cytomegalovirus disease in organ transplant recipients and provides a simpler treatment strategy, but care should be taken in extrapolating to organ transplant recipients not properly represented in the present study.
authors.affiliation: Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway.
authors.forename: A
authors.initials: A
authors.lastname: Asberg
authors.forename: A
authors.initials: A
authors.lastname: Humar
authors.forename: H
authors.initials: H
authors.lastname: Rollag
authors.forename: A G
authors.initials: AG
authors.lastname: Jardine
authors.forename: H
authors.initials: H
authors.lastname: Mouas
authors.forename: M D
authors.initials: MD
authors.lastname: Pescovitz
authors.forename: D
authors.initials: D
authors.lastname: Sgarabotto
authors.forename: M
authors.initials: M
authors.lastname: Tuncer
authors.forename: I L
authors.initials: IL
authors.lastname: Noronha
authors.forename: A
authors.initials: A
authors.lastname: Hartmann
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects*; D003587:Cytomegalovirus / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000473:pathology / Q000517:prevention & control* / Q000821:virology; D004279:DNA, Viral / Q000235:genetics; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation / Q000009:adverse effects*; D012189:Retrospective Studies; D016896:Treatment Outcome; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D000077562:Valganciclovir; D015774:Ganciclovir