This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of Cytomegalovirus (CMV) infection and disease in a solid organ transplant recipient.
This study is an open label trial in which Letermovir will be prescribed to prevent the recurrence of CMV infection and disease in a solid organ transplant recipient following treatment of CMV infection or disease.
Adult (> 18 years old) solid organ transplant recipients (heart, kidney or liver patients) recovering from treated CMV disease in whom the clinician deems that the patient need secondary prophylaxis and in whom written informed consent is obtained.
Patient able to participate with follow up for 6 months
Not enrolled in competing clinical trials
Patients with creatinine clearance less than 10 ml per min at time of enrollment
Hypersensitivity to letermovir or has a CMV isolate which is known to be resistant to letermovir based on prior testing
On CVVH or renal dialysis at the time of enrollment
Has Child Pugh Class C severe hepatic insufficiency at screening.
Single group
Letermovir
DrugOpen label 480 mg given daily for 60 days
Rate of Relapse after prophylaxis
Proportion of patients with relapsing CMV disease up to 6 months after starting drug
Opportunistic infection
Rate of opportunistic infections or other infectious outcomes in the letermovir arm.
Adverse events associated with taking letermovir
Tolerability and compliance of patients taking letermovir in terms of adverse events
Neutropenia
Duration and nadir of neutropenia in the letermovir group
Rejection
Rate of rejection at 6 months after starting secondary prophylaxis in the letermovir arm.
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