Pre-emptive treatment of cytomegalovirus infection in kidney transplant recipients with letermovir: results of a Phase 2a study.
Stoelben S, Arns W, et al.Transplant International 2014;27(1):77-86
Aims
To compare letermovir to local standard of care for a 14-day treatment period conducted in adults with active cytomegalovirus (CMV) replication.
Interventions
Patients were treated with oral letermovir 40mg twice a day versus 80mg once a day versus local standard of care as control.
Participants
47 renal transplant recipients with CMV viraemia.
Outcomes
The primary outcome was the CMV-DNA load during the treatment period. Secondary objectives included assessment of safety, tolerability, and pharmacokinetics of letermovir.
Follow-up
14 days.
CET Conclusions
Letermovir is a novel antiviral agent with a mode of action directed against the viral terminase complex. In this proof of concept study patients with a CMV viraemia were randomised to receive Letermovir, either 40mg twice daily or 80mg once daily, for 14 days or the local standard of care with valganciclovir. There was a reduction in the CMV virus load versus baseline in all three groups and Letermovir appeared to be as well tolerated and effective as an anti CMV drug at both doses in comparison with valganciclovir. Thus Letermovir might provide another agent for managing CMV infection.
Data analysis
Modified intention-to-treat analysis
Trial registration
European Clinical Trials Database - EudraCT 2006-006148-69