Learn about:<\/strong><\/p>\n\n\n\n\n The Observed Failure (OF) approach was used, where subjects who discontinued prematurely from the study for any reason or were missing data at the time point were not counted as failures.<\/p>\n\n\n\n (a) CMV disease cases confirmed by an independent adjudication committee.Primary endpoint results through Week 52 post-transplant<\/strong><\/h2><\/div>\n\n\n\n
In high-risk CMV D+\/R- adult kidney transplant recipients, PREVYMIS\u00ae<\/sup> (letermovir)
met the primary end point in a non-inferiority study vs valganciclovirc<\/sup><\/h3><\/div>\n\n\n\nPREVYMIS\u00ae (letermovir) was noninferior to valganciclovir in preventing CMV disease<\/strong><\/h2><\/div>\n\n\n\n
Incidence of CMV disease through Week 52 (~365 days) post-transplant (OF approach)<\/strong><\/h3><\/div>\n\n\n\n
CMV diseasea<\/sup> through Week 52<\/strong><\/strong><\/td> PREVYMIS<\/strong><\/td> Valganciclovir<\/strong><\/td><\/tr> (n=289)<\/td> (n=297)<\/td><\/tr> 10%<\/strong><\/td> 12%<\/strong><\/td><\/tr> CMV syndromeb<\/sup><\/strong><\/td> 8%<\/strong><\/td> 11%<\/strong><\/td><\/tr> CMV end-organ disease<\/strong><\/td> 2%<\/strong><\/td> <1%<\/strong><\/td><\/tr> Stratum-adjusted treatment difference
(95% CI) (PREVYMIS-valganciclovir)<\/strong><\/td>-1.4<\/strong><\/td><\/tr> (-6.5, 3.8)c<\/sup><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
(b) Defined as evidence of CMV in blood by viral isolation, rapid culture, antigenemia, or nucleic acid testing, and two or more of the following: 1) fever \u226538\u00b0C for at least 2 days, 2) new or increased malaise\/fatigue, 3) leukopenia or neutropenia on two separate measurements at least 24 hours apart, 4) \u22655% atypical lymphocytes, 5) thrombocytopenia, 6) elevation of ALT or AST to 2x ULN.
(c) Based on a non-inferiority margin of 10%, PREVYMIS is noninferior to valganciclovir.<\/em><\/p>\n\n\n\nEfficacy that can go head-to-head vs valganciclovir<\/strong><\/strong><\/h2><\/div>\n\n\n\n