The goal of this quasi-experimental multicenter before-after cohort study, phase II study is to evaluate the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease."
Adults over 18 years old
Lung transplant recipients (D+/R-) pre-transplant.
Having an undetectable CMV polymerase chain reaction assay (PCR) within the 96 hours prior to the start of letermovir prophylaxis.
Patients who have provided written informed consent.
HIV-infected patients.
Patients with multivisceral transplant.
Patients unable to comply with the follow-up protocol.
Receiving a different antiviral prophylaxis other than ganciclovir prior to letermovir prophylaxis.
Parallel
Letermovir 240 mg Oral Tablet
DrugTreatment will commence as soon as subjects can receive oral medication, with a maximum timeframe of 28 days after transplantation. If patients cannot receive oral medication after transplantation, initial prophylaxis with ganciclovir per clinical practice will be allowed. Medication will be discontinued 12 months after treatment initiation.
Incidence of CMV disease/replication
CMV replication: The term 'replication' can be used to indicate evidence of multiplication and is sometimes used interchangeably with CMV infection CMV disease: It is defined as symptomatic replication or invasive disease of organs or tissues that requires treatment at the investigator's discretion."
Antiviral prophylaxis received:
Doses administered of Letermovir or Valganciclovir
Dose of non anti-viral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)
Drug Dose (mg/hour)
Administration route of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)
Drug Administration Route
Duration of treatment of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)
Drug treatment duration (days)
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Maimónides Biomedical Research Institute of Córdoba
Lead sponsor
MERCK SHARP & DOHME DE ESPAÑA S.A.
Collaborator
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