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

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 o...

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Bibliographic Details
Published in:	American journal of transplantation 2012-11, Vol.12 (11), p.3021-3030
Main Authors:	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.
Format:	Article
Language:	eng
Subjects:	Acyclovir - administration & dosage Administration, Oral Antiviral Agents - administration & dosage Benzimidazoles - administration & dosage Biological and medical sciences Chirurgie Clinical trials Cytomegalovirus Cytomegalovirus Infections - diagnosis Cytomegalovirus Infections - drug therapy Disease Disease prevention Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Follow-Up Studies Ganciclovir - administration & dosage Gastroenterology & hepatology Gastroentérologie & hépatologie Graft Rejection - prevention & control Graft Rejection - virology Graft Survival Herpesviridae Human health sciences Humans Infectious diseases liver transplantation Liver Transplantation - adverse effects Liver Transplantation - immunology Liver Transplantation - methods Liver, biliary tract, pancreas, portal circulation, spleen Male Maribavir Medical sciences Medicin och hälsovetenskap Postoperative Complications - drug therapy Postoperative Complications - virology prevention Prevention and actions Prospective Studies Public health. Hygiene Public health. Hygiene-occupational medicine Ribonucleosides - administration & dosage Risk Assessment Sciences de la santé humaine Surgery Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the digestive system Transplants & implants Treatment Outcome Viral diseases
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Summary:	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. Despite maribavir's in vitro activity against cytomegalovirus, this multicenter randomized trial shows that oral maribavir dosed at 100 mg twice daily is not adequate for prevention of cytomegalovirus disease in cytomegalovirus‐seronegative liver transplant recipients with cytomegalovirus‐seropositive donors.
ISSN:	1600-6135 1600-6143 1600-6143