Learn about:<\/strong><\/p>\n\n\n\n\n (a) Clinically significant CMV infection was defined as either the occurrence of CMV end-organ disease or initiation of anti-CMV PET, based on documented CMV viremia and the clinical condition of the patient. Viremia was determined using the Roche COBAS\u00ae<\/sup> AmpliPrep\/COBAS TaqMan\u00ae<\/sup> assay; lower limit of quantification was 137 IU\/mL<\/span>, which is approximately 150 copies\/mL<\/span>.Prophylaxis through Week 14 (~100 days) post-HSCT in adults<\/strong><\/h2><\/div>\n\n\n\n
Clinically significant CMV infection through Week 24 (~168 days) in adult HSCT patients<\/h2><\/div>\n\n\n\n
PREVYMIS\u00ae (letermovir) demonstrated significant efficacy vs placebo in the primary endpoint: Clinically significant CMV infectiona<\/sup> through Week 24 (NC=F approach)b<\/sup><\/strong><\/h3><\/div>\n\n\n\n
Parameter<\/strong><\/th> PREVYMIS
<\/strong>(n=325)<\/td>Placebo
<\/strong>(n=170)<\/td><\/tr>Proportion of subjects who failed prophylaxis<\/strong>
<\/td>38%<\/strong>
<\/td>61%<\/strong><\/td><\/tr> Treatment difference for PREVYMIS vs placebo (95% CI)<\/td> -23.5 (-32.5, -14.6)
P<\/em> <0.0001<\/td><\/td><\/tr> Reasons for failuresc<\/sup><\/strong><\/td> <\/td> <\/td><\/tr> Clinically significant CMV infection by Week 24d<\/sup><\/strong><\/td> 18%<\/strong><\/td> 42%<\/strong><\/td><\/tr> Initiation of PET based on documented CMV viremia<\/td> 16%<\/td> 40%<\/td><\/tr> CMV end-organ disease<\/td> 2%<\/td> 2%<\/td><\/tr> Discontinued study before Week 24e<\/sup><\/strong><\/td> 17%<\/strong><\/td> 16%<\/strong><\/td><\/tr> Missing outcome in Week 24 visit window<\/strong><\/td> 3%<\/strong><\/td> 3%<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
(b) The Noncompleter=Failure (NC=F) approach was used in which patients who discontinued from the study prior to Week 24 post-HSCT or had a missing outcome at Week 24 post-HSCT were counted as failures.
(c) The categories of failure are mutually exclusive and based on the hierarchy of categories in the order listed.
(d) Through Week 14, 8% of subjects in the PREVYMIS group and 39% of subjects in the placebo group experienced clinically significant CMV infection.
(e) Reasons for discontinuation included adverse event (AE), death, lost to follow-up, physician decision, and withdrawal by subject.<\/em><\/p>\n\n\n\nRate of clinically significant CMV infection in adults<\/h2><\/div>\n\n\n\n
Significantly lower rate of onset of clinically significant CMV <\/sup>infection for PREVYMIS vs placebo1<\/sup><\/strong><\/h3><\/div>\n\n\n