{"id":81,"date":"2023-03-24T12:52:52","date_gmt":"2023-03-24T12:52:52","guid":{"rendered":"https:\/\/www.merckconnect.com\/prevymis\/?page_id=81"},"modified":"2026-03-30T13:25:39","modified_gmt":"2026-03-30T13:25:39","slug":"hsct-study-design","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/prevymis\/hsct-study-design\/","title":{"rendered":"Study design"},"content":{"rendered":"<link rel='stylesheet' id='vivid360-spacer-css-css' href='https:\/\/www.merckconnect.com\/prevymis\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/spacer\/css\/style.min.css?ver=1770880337' media='all' \/>\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n<link rel='stylesheet' id='vivid360-heading-css-css' href='https:\/\/www.merckconnect.com\/prevymis\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/heading\/css\/style.min.css?ver=1770880337' media='all' \/>\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"a3f448418-c5b8-4cbe-bb89-5f547bcad6e4\"><h1 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h1FontSizeDesktop);--tabletFontSize:var(--h1FontSizeDesktop);--mobileFontSize:var(--h1FontSizeMobile);--desktopLineHeightSize:var(--h1LineHeightDesktop);--tabletLineHeightSize:var(--h1LineHeightDesktop);--mobileLineHeightSize:\" id=\"top\"><strong>Study designs in adult hematopoietic stem cell transplantation (HSCT) patients<\/strong><\/h1><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8 spacer-undefined\"><\/div>\n\n\n\n<p><a href=\"#prop100\" aria-label=\"#\">Prophylaxis through Week 14 (~100 days) post-HSCT in adults<\/a><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><a href=\"#prop200\" aria-label=\"#\">Prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT in adults<\/a><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p><a href=\"https:\/\/www.merckconnect.com\/prevymis\/hsct-pediatric\/\" aria-label=\"#\">Pediatric information for HSCT<\/a><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-tablet-fontsize\" id=\"a14d9608c-2a1f-48f3-bed6-749e6f36aa25\"><h2 class=\"has-primary-color content-width fontWeightRegular mt-0 mb-0\" style=\"--desktopFontSize:30px;--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:22px;--desktopLineHeightSize:45px;--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"prop100\"><strong>Prophylaxis through Week 14 (~100 days) post-HSCT in adults<\/strong><\/h2><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>Cytomegalovirus (CMV) prophylaxis was assessed in a randomized, multicenter, double-blind, placebo-controlled, pivotal, phase 3 study of adult CMV-seropositive recipients [R+] of allogeneic hematopoietic stem cell transplant (HSCT). Patients were randomized 2:1 to PREVYMIS or placebo and stratified by study site and high vs low risk (N=565).<\/p>\n\n\n<link rel='stylesheet' id='vivid360-list-css-css' href='https:\/\/www.merckconnect.com\/prevymis\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/list\/css\/style.min.css?ver=1770880337' media='all' \/>\n\n<div class=\"vivid-block-list content-width  default-list block-c4c0d05d-51a9-4d11-80da-0823c6a01200\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-c4c0d05d-51a9-4d11-80da-0823c6a01200\"><ul class=\"first-level\"><li>All-cause mortality through Week 48 post-transplant was a prespecified, exploratory analysis.<sup>1<\/sup><\/li><li>The protocol-specified guidance for CMV DNA thresholds for the initiation of preemptive therapy (PET) during the treatment period were \u2265150 copies\/mL or &gt;300 copies\/mL for subjects in the high- and low-risk strata, respectively.<\/li><\/ul><\/div>\n\n\n<link rel='stylesheet' id='vivid360-image-module-css-css' href='https:\/\/www.merckconnect.com\/prevymis\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/image-module\/css\/style.min.css?ver=1774422151' media='all' \/>\n\n<div id=\"\" class=\"wp-block-vivid360-image-module ratio-50-50 content-above one-col full-page-width\"><div class=\"vivid360-block-image-module__content-wrapper content-align-left\" id=\"contentDiv\"><\/div><figure class=\"vivid360-block-image-module__image-container\"><picture><source media=\"(max-width: 767px)\" data-srcset=\"https:\/\/www.merckconnect.com\/prevymis\/wp-content\/uploads\/sites\/88\/2026\/03\/CAT_CMV_transplant_to_week_48_Chart_LO.png?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/prevymis\/wp-content\/uploads\/sites\/88\/2026\/03\/CAT_CMV_transplant_to_week_48_Chart_LO.png?w=1440\"\/><img decoding=\"async\" width=\"1500\" height=\"543\" data-src=\"https:\/\/www.merckconnect.com\/prevymis\/wp-content\/uploads\/sites\/88\/2026\/03\/CAT_CMV_transplant_to_week_48_Chart_LO.png\" loading=\"lazy\" src=\"https:\/\/www.merckconnect.com\/prevymis\/wp-content\/uploads\/sites\/88\/2026\/03\/CAT_CMV_transplant_to_week_48_Chart_LO.png\" alt=\"Study Design of PREVYMIS\u00ae (letermovir) for Cytomegalovirus (CMV) Prophylaxis in Adult Allogeneic HSCT Recipients Through Week 14 Post-HSCT\"\/><\/picture><figcaption class=\"caption-align-left noCaptionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><\/p><\/figcaption><\/figure><\/div>\n\n\n\n<p class=\"has-small-font-size\"><em>(a) When coadministered with cyclosporine, the dose of PREVYMIS was decreased to <span class=\"no-wrap-text\">240 mg<\/span> once daily, oral or IV infusion.<\/em><\/p>\n\n\n\n<div class=\"vivid-block-list content-width  default-list block-2a3bce47-3be8-49fb-895b-3563ae171ab6\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-2a3bce47-3be8-49fb-895b-3563ae171ab6\"><ul class=\"first-level\"><li>Patients were considered at increased risk for CMV reactivation if they had 1 or more of the following factors:<ul class=\"second-level\"><li>Human leukocyte antigen (HLA)-related donor with at least 1 mismatch at 1 of 3 HLA-gene loci: HLA-A, -B, or -DR<\/li><li>Haploidentical donor; unrelated donor with at least 1 mismatch at 1 of 4 HLA-gene loci: HLA-A, -B, -C, or -DRB1<\/li><li>Use of umbilical cord blood as the stem cell source<\/li><li>Use of ex vivo T-cell\u2013depleted grafts<\/li><\/ul><ul class=\"second-level\"><li>Grade 2 or greater graft-versus-host disease (GVHD), requiring systemic corticosteroids<\/li><\/ul><\/li><\/ul><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-tablet-fontsize\" id=\"a1b1175c6-3f1f-450c-b4ca-c9275b71e398\"><h2 class=\"has-primary-color content-width fontWeightRegular mt-0 mb-0\" style=\"--desktopFontSize:30px;--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:22px;--desktopLineHeightSize:45px;--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"prop200\"><strong>Prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT in adults<\/strong><\/h2><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The efficacy of extending PREVYMIS prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT in adult patients at risk for late CMV infection and disease was assessed in a multicenter, double-blind, placebo-controlled Phase 3 trial in adult CMV-seropositive recipients [R+] of an allogeneic HSCT. Eligible subjects who completed PREVYMIS prophylaxis through ~100 days post-HSCT were randomized (2:1) to receive PREVYMIS or placebo from Week 14 through Week 28 post-HSCT.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div id=\"\" class=\"wp-block-vivid360-image-module ratio-50-50 content-above one-col full-page-width\"><div class=\"vivid360-block-image-module__content-wrapper content-align-left\" id=\"contentDiv\"><\/div><figure class=\"vivid360-block-image-module__image-container\"><picture><source media=\"(max-width: 767px)\" data-srcset=\"https:\/\/www.merckconnect.com\/prevymis\/wp-content\/uploads\/sites\/88\/2026\/03\/CAT_200_Day_Study_Design_RGB_LO.png?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/prevymis\/wp-content\/uploads\/sites\/88\/2026\/03\/CAT_200_Day_Study_Design_RGB_LO.png?w=1440\"\/><img decoding=\"async\" width=\"1293\" height=\"588\" data-src=\"https:\/\/www.merckconnect.com\/prevymis\/wp-content\/uploads\/sites\/88\/2026\/03\/CAT_200_Day_Study_Design_RGB_LO.png\" loading=\"lazy\" src=\"https:\/\/www.merckconnect.com\/prevymis\/wp-content\/uploads\/sites\/88\/2026\/03\/CAT_200_Day_Study_Design_RGB_LO.png\" alt=\"Study Design of PREVYMIS\u00ae (letermovir) for Cytomegalovirus (CMV) Prophylaxis in Adult Allogeneic HSCT Recipients From Week 14 Through Week 28 Post-HSCT\"\/><\/picture><figcaption class=\"caption-align-left noCaptionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><\/p><\/figcaption><\/figure><\/div>\n\n\n\n<p class=\"has-small-font-size\"><em>(a) When coadministered with cyclosporine, the dose of PREVYMIS was adjusted to <span class=\"no-wrap-text\">240 mg<\/span> once daily, oral or IV infusion.<\/em><\/p>\n\n\n\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"a82169e58-f070-49a6-a260-75da3826ed3f\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:18px;--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:27px;--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"\">Reference<\/h3><\/div>\n\n\n\n<div class=\"vivid-block-list content-width  block-c515a39f-1d62-45eb-a04f-a60435b6da64\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-c515a39f-1d62-45eb-a04f-a60435b6da64\"><ol class=\"first-level default-order\"><li>Marty FM, Ljungman P, Chemaly RF, et al. Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation. <em>N Engl J Med<\/em>. 2017;377(25):2433\u20132444. doi:10.1056\/NEJMoa1706640<\/li><\/ol><\/div>\n\n\n\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<p><a href=\"#top\" aria-label=\"#\">Back to top<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Prophylaxis through Week 14 (~100 days) post-HSCT in adults Prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT in&#8230;<\/p>\n","protected":false},"author":699,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[270],"ga4_page_businessunit":[],"ga4_page_campaign":[],"ga4_page_content_purpose":[285],"ga4_page_customer_journey_stage":[336],"ga4_page_customer_specialty":[361],"ga4_page_experience":[],"ga4_page_indication":[],"ga4_page_material_intent":[576],"ga4_page_product":[599],"ga4_page_region":[910],"ga4_page_therapeuticarea":[],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-81","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Phase 3 Study of Adult CMV-seropositive Recipients of Allogeneic 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