Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients

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Asberg A., Humar A., Rollag H., Jardine A. G., Mouas H., Pescovitz M. D., ...More

AMERICAN JOURNAL OF TRANSPLANTATION, vol.7, no.9, pp.2106-2113, 2007 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 7 Issue: 9
  • Publication Date: 2007
  • Doi Number: 10.1111/j.1600-6143.2007.01910.x
  • Journal Name: AMERICAN JOURNAL OF TRANSPLANTATION
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.2106-2113
  • Keywords: cytomegalovirus disease, ganciclovir, posttransplant, valganciclovir, viral kinetics, PREEMPTIVE THERAPY, CMV INFECTION, MANAGEMENT, KINETICS, EFFICACY, SOCIETY, PLASMA, KIDNEY, SAFETY
  • Akdeniz University Affiliated: No

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.