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.
Winston DJ, Saliba F, et al.American Journal of Transplantation 2012 [record in progress].
Aims
To explore whether maribavir dosed at 100 mg orally twice daily would confer benefit on the prevention of cytomegalovirus (CMV) disease in liver transplant recipients.
Interventions
Oral maribavir (100 mg twice daily) with oral acyclovir (400 mg twice daily) versus oral ganciclovir alone (1000 mg three times daily).
Participants
307 liver transplant patients.
Outcomes
The primary endpoint was the incidence of CMV disease within 6 months of transplantation. Secondary efficacy endpoints included the time to onset of CMV disease, the incidence and time to onset of CMV infection, the start of either preemptive therapy or the treatment of established CMV disease, graft function, patients survival and incidence of non-CMV infections. Safety assessment included adverse events, allograft rejection, and changes in physical examinations, standard laboratory tests, electrocardiograms and urinalyses.
Follow-up
6-12 months
CET Conclusions
In this non inferiority trial comparing maribavir (an oral benzimidazole riboside) with potent in-vitro activity against CMV infection, high risk liver transplant recipients (seronegative recipients receiving a liver from a seropositive donor) were given 100mg of maribavir twice a day or oral ganciclovir. The trial was terminated prematurely by the data monitoring committee when they recognised an imbalance between CMV infection in the maribavir arm so that the modified intention to treat patients were less than would have been planned. At a dose of 100mg twice daily maribavir is safe but is not adequate for the prevention of CMV disease in these high risk liver transplant recipients. Further trial, perhaps with higher doses, will be required if this agent is to be considered further.
Data analysis
Modified intention-to-treat analysis
Trial registration
Not reported