Health
Prevymis Approved for CMV Disease Prevention in Kidney Transplant Recipients
Food and Drug Administration (FDA) Approves Previmis® (Rethermovir) for the prevention of cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients (donor CMV seropositive/recipient CMV seronegative) [D+/R-]).
This approval was supported by data from a Phase 3 trial (ClinicalTrials.gov Identifier: NCT03443869) to assess the efficacy and safety of letermovir for preventing CMV disease in high-risk adult kidney transplant recipients.
Patients were randomly assigned to receive concomitant letermovir 480 mg orally once daily. Acyclovir (n=289), or Valganciclovir 900 mg orally once daily in combination with placebo to acyclovir (n=297), within 7 days post-kidney transplant to within 28 weeks post-transplant, followed up to 52 weeks.
At week 52, treatment with letermovir was found to be effective and not inferior to valganciclovir. 10% of patients in the letermovir group developed her CMV disease compared to 12% of patients in the valganciclovir group (stratification-adjusted difference, -1.4) [95% CI, -6.5, 3.8]).
Incidence of CMV syndrome (defined as evidence of CMV in blood by viral isolation, rapid culture, antigenemia, or nucleic acid testing, with at least 2 of the following: 1) fever above 38°C for at least 2 days, 2) New or increased malaise/fatigue, 3) leukopenia or neutropenia when measured at least 24 hours apart, 4) atypical lymphocytes ≥5%, 5) thrombocytopenia, 6) ALT or up to 2x ULN in AST) were 8% and 11%. in the letermovir and valganciclovir divisions, respectively.
Efficacy was found to be comparable across all subgroups, including patients who used or did not use highly cytolytic antilymphocytic immunotherapy during induction.
Exploratory findings showed a difference in CMV disease incidence between the letermovir and valganciclovir groups up to 28 weeks after transplantation of -1.7% (95% CI, -3.4, 0.1). By 28 weeks post-transplant, five of his cases of CMV disease were reported in the valganciclovir group, but none in the letermovir group.
The most common side effect reported with letermovir (more frequent than with valganciclovir) was diarrhea.
Prevymis is supplied as 240mg and 480mg tablets and in 240mg/12mL and 480mg/12mL single dose vials. In clinical trials, Previmis was administered orally or intravenously.
Dose adjustments may be required when Prevymis is used in combination with cyclosporine. Monitoring for CMV reactivation after completion of Prevymis prophylaxis is recommended.
Previmis It is also indicated for the prevention of CMV infection and disease in adult CMV-seropositive recipients. [R+] Study of allogeneic hematopoietic stem cell transplantation.
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