†The Maribavir 1263-301 Clinical Study Group is listed in the Acknowledgement Section.
Efficacy and Safety of Maribavir Dosed at 100 mg Orally Twice Daily for the Prevention of Cytomegalovirus Disease in Liver Transplant Recipients: A Randomized, Double-Blind, Multicenter Controlled Trial
Article first published online: 4 SEP 2012
© Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons
American Journal of Transplantation
Volume 12, Issue 11, pages 3021–3030, November 2012
How to Cite
Winston, D. J., Saliba, F., Blumberg, E., Abouljoud, M., Garcia-Diaz, J. B., Goss, J. A., Clough, L., Avery, R., Limaye, A. P., Ericzon, B. G., Navasa, M., Troisi, R. I., Chen, H., Villano, S. A., Uknis, M. E. and for the 1263–301 Clinical Study Group (2012), Efficacy and Safety of Maribavir Dosed at 100 mg Orally Twice Daily for the Prevention of Cytomegalovirus Disease in Liver Transplant Recipients: A Randomized, Double-Blind, Multicenter Controlled Trial. American Journal of Transplantation, 12: 3021–3030. doi: 10.1111/j.1600-6143.2012.04231.x
- Issue published online: 27 OCT 2012
- Article first published online: 4 SEP 2012
- Received 06 March 2012, revised 24 May 2012 and accepted for publication 06 June 2012
Vol. 13, Issue 2, 529, Article first published online: 28 JAN 2013
- liver transplantation;
Maribavir is an oral benzimidazole riboside with potent in vitro activity against cytomegalovirus (CMV), including some CMV strains resistant to ganciclovir. In a randomized, double-blind, multicenter trial, the efficacy and safety of prophylactic oral maribavir (100 mg twice daily) for prevention of CMV disease were compared with oral ganciclovir (1000 mg three times daily) in 303 CMV-seronegative liver transplant recipients with CMV-seropositive donors (147 maribavir; 156 ganciclovir). Patients received study drug for up to 14 weeks and were monitored for CMV infection by blood surveillance tests and also for the development of CMV disease. The primary endpoint was Endpoint Committee (EC)-confirmed CMV disease within 6 months of transplantation. In a modified intent-to-treat analysis, the noninferiority of maribavir compared to oral ganciclovir for prevention of CMV disease was not established (12% with maribavir vs. 8% with ganciclovir: event rate difference of 0.041; 95% CI: −0.038, 0.119). Furthermore, significantly fewer ganciclovir patients had EC-confirmed CMV disease or CMV infection by pp65 antigenemia or CMV DNA PCR compared to maribavir patients at both 100 days (20% vs. 60%; p < 0.0001) and at 6 months (53% vs. 72%; p = 0.0053) after transplantation. Graft rejection, patient survival, and non-CMV infections were similar for maribavir and ganciclovir patients. Maribavir was well-tolerated and associated with fewer hematological adverse events than oral ganciclovir. At a dose of 100 mg twice daily, maribavir is safe but not adequate for prevention of CMV disease in liver transplant recipients at high risk for CMV disease.