The Efficacy and Safety of 200 Days Valganciclovir Cytomegalovirus Prophylaxis in High-Risk Kidney Transplant Recipients

Humar, A. et al. (2010) The Efficacy and Safety of 200 Days Valganciclovir Cytomegalovirus Prophylaxis in High-Risk Kidney Transplant Recipients. American Journal of Transplantation, 10(5), pp. 1228-1237. (doi: 10.1111/j.1600-6143.2010.03074.x)

Abstract

Late-onset cytomegalovirus (CMV) disease is a significant problem with a standard 3-month prophylaxis regimen. This multicentre, double-blind, randomized controlled trial compared the efficacy and safety of 200 days' versus 100 days' valganciclovir prophylaxis (900 mg once daily) in 326 high-risk (D+/R-) kidney allograft recipients. Significantly fewer patients in the 200-day group versus the 100-day group developed confirmed CMV disease up to month 12 posttransplant (16.1% vs. 36.8%; p < 0.0001). Confirmed CMV viremia was also significantly lower in the 200-day group (37.4% vs. 50.9%; p = 0.015 at month 12). There was no significant difference in the rate of biopsy-proven acute rejection between the groups (11% vs. 17%, respectively, p = 0.114). Adverse events occurred at similar rates between the groups and the majority were rated mild-to-moderate in intensity and not related to study medication. In conclusion, this study demonstrates that extending valganciclovir prophylaxis (900 mg once daily) to 200 days significantly reduces the incidence of CMV disease and viremia through to 12 months compared with 100 days' prophylaxis, without significant additional safety concerns associated with longer treatment. The number needed to treat to avoid one additional patient with CMV disease up to 12 months posttransplant is approximately 5

• Item Type: Articles
• Keywords: ACUTE REJECTION Antivirals CANADA CONTROLLED-TRIAL cytomegalovirus (CMV) DISEASE DOUBLE-BLIND EVENTS HEART HIGH-RISK Incidence INDEFINITE PROPHYLAXIS INFECTION LUNG TRANSPLANTATION MANAGEMENT Medication NUMBER ORAL GANCICLOVIR PATIENT patients PREVENTION PROPHYLAXIS RATES RECIPIENTS RENAL-TRANSPLANTATION SAFETY SOLID-ORGAN TRANSPLANTATION SURGERY Treatment TRIAL valganciclovir
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Jardine, Professor Alan
• Authors: Humar, A., Lebranchu, Y., Vincenti, F., Blumberg, E. A., Punch, J. D., Limaye, A. P., Abramowicz, D., Jardine, A. G., Voulgari, A. T., Ives, J., Hauser, I. A., and Peeters, P.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences
• Journal Name: American Journal of Transplantation
• Publisher: Wiley-Blackwell Publishing, Inc.
• ISSN: 1600-6135