{"id":5416,"date":"2024-09-26T14:08:15","date_gmt":"2024-09-26T14:08:15","guid":{"rendered":"https:\/\/www.roctavian.com\/en-us\/?page_id=5416"},"modified":"2025-11-20T12:10:09","modified_gmt":"2025-11-20T12:10:09","slug":"roctavian-results","status":"publish","type":"page","link":"https:\/\/www.roctavian.com\/en-us\/roctavian-results\/","title":{"rendered":"ROCTAVIAN RESULTS"},"content":{"rendered":"<div id=\"acf-block-68fa2df36ff45\" class=\"hero hero-roctavian\">\n\t<div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/roc-back-02.png?v=0.113);\"><\/div>\n\t<div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/roc-back-mobile.png?v=0.113);\"><\/div>\n\t<div class=\"overlay\"><\/div>\n\n\t<div class=\"hero-content\">\n\t\t<div class=\"title-area\">\n\t\t\t                <h1>ROCTAVIAN CLINICAL<br \/>\nSTUDY RESULTS\n<\/h1>\n            \t\t\t\t\t<\/div>\t\t\n                    <div class=\"text-area\">\n                <div class=\"text-area-content\">\n                                        <div class=\"text\">\n                        <p>Learn how doctors can confirm eligibility with simple blood tests<\/p>\n                    <\/div>\n                                                                <div class=\"cta\">\n                                                                                    <p><a class=\"button\" href=\"https:\/\/www.roctavian.com\/en-us\/am-i-ready-for-roctavian\/\" target=\"_self\">AM I ELIGIBLE?<\/a><\/p>\n                        <\/div>\n                                    <\/div>\n            <\/div>\n                            <div class=\"image-caption\">\n                <p>Andrew W. received ROCTAVIAN in 2018 as part of a clinical study.<\/p>\n            <\/div>\n\n            <div class=\"additional-caption\">\n                <p>ROCTAVIAN is indicated for adults only.<\/p>\n            <\/div>\n        \t<\/div>\n<\/div>\n    <div class=\"hero-footer hero-footer-roctavian\">\n        <div class=\"wrapper\">\n            <div class=\"inner-wrapper\">\n                <p>Now with 5 years of clinical data<\/p>\n            <\/div>\n        <\/div>\n    <\/div>\n\n\n<div id=\"studied-in-LB\" class=\"block wrapped-content bg-band block-zero-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-66fabef2b76b7\" class=\"block-wysiwyg\">\n            <h2>Studied in the longest and largest gene therapy clinical study for severe hemophilia A*<\/h2>\n<ul>\n<li>ROCTAVIAN is a one-time treatment that helps people make their own Factor VIII, so they may be able to<sup>\u2020<\/sup>:\n<ul>\n<li>Maintain Factor VIII levels in the mild range or higher<\/li>\n<li>Experience bleed control for years<\/li>\n<li>Stop and stay off continuous prophylaxis for years<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Now with 5 years of safety profile data<\/strong><\/p>\n<p><small>*At FDA approval, ROCTAVIAN had the longest and largest Phase 3 clinical study for gene therapy in severe hemophilia A.<\/small><br \/>\n<sup>\u2020<\/sup><small>Individual Factor VIII levels produced and durability of levels reached can vary. ROCTAVIAN did not work for everyone. Some patients did not respond to treatment or lost response to treatment.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"5-years-WT\" class=\"block wrapped-content block-tight-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fa329a08e25\" class=\"block-wysiwyg\">\n            <h2>5 years after ROCTAVIAN, the average Factor VIII activity level was in the mild hemophilia range*<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-68fa329a08ffd\">\n    <div class=\"image image-responsive image-rounded image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_1-1900x566.png\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_1-1.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-68fa329a0902f\" class=\"block-wysiwyg\">\n            <ul>\n<li>Factor VIII levels can be measured using either a one-stage assay (shown here) or a chromogenic assay. One-stage results consistently show higher Factor VIII levels<\/li>\n<li>ROCTAVIAN was studied in 112 people whose data were collected for at least 6 months before their infusion (rollover population) and 22 people who immediately received their infusion (directly enrolled population). In the rollover population, the average Factor VIII level was 29.8% at Year 5<\/li>\n<li>Factor VIII activity levels are based on definitions from the World Federation of Hemophilia. Here, we define mild as 5% to less than 40% and near-normal to normal as 40% to less than or equal to 150%<\/li>\n<li>Some people did not respond to treatment or lost response to treatment. It is not possible to predict if and how much you may benefit from ROCTAVIAN<\/li>\n<\/ul>\n<p><small>Standard deviation (SD) shows how spread out the data are from the average.<\/small><br \/>\n<small>*The follow-up period began 5 weeks or more after administration and consisted of a median follow-up of 5 years with a range of 1.7 to 5.2 years.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"84%-VIII-WT\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fa34bd561af\" class=\"block-wysiwyg\">\n            <h2>You could maintain Factor VIII activity levels in the mild range or higher for years*<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-68fa34bd56425\">\n    <div class=\"image image-responsive image-rounded image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_2-1900x843.png\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_2-1.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n            <figcaption><p><small><br \/>\n*Here, we define Factor VIII activity levels: mild as 5% to less than 40% and near-normal to normal as 40% to less than or equal to 150%. Some patients did not respond to treatment or lost response to treatment. It is not possible to predict if and how much you may benefit from ROCTAVIAN. Some patients had elevated Factor VIII levels but didn\u2019t respond to ROCTAVIAN.<\/small><br \/>\n<sup>\u2020<\/sup><small>Factor VIII levels can be measured using either a one-stage assay (shown here) or a chromogenic assay. One-stage results consistently show higher Factor VIII levels.<\/small><br \/>\n<sup>\u2021<\/sup><small>Available data from rollover population (n=112) at week 260.<\/small><br \/>\n<sup>\u00a7<\/sup><small>Patients in the clinical trial experienced Factor VIII levels of &lt;1%. Under the 5-year analysis of available, valid data, the range was 1.5 to 321.2.<br \/>\n<\/small><\/p>\n<\/figcaption>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"bleed-control-LB\" class=\"block wrapped-content bg-band\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fa364d00650\" class=\"block-wysiwyg\">\n            <h2 class=\"p1\">ROCTAVIAN improved bleed control vs baseline for 5 years with a single infusion<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-68fa364d00697\">\n    <div class=\"image image-responsive image-rounded image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/88.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_3-1.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-68fa364d006c2\" class=\"block-wysiwyg\">\n            <ul>\n<li>Before ROCTAVIAN, the average (mean) annualized bleeding rate (ABR) was 5.4 (6.9). After ROCTAVIAN, the average ABR dropped to 3.9 (7.9)<\/li>\n<li>Results are based on 112 people whose data were collected for at least 6 months while they were taking prophylaxis. These data were compared with data from the 5-year period after they received ROCTAVIAN*<\/li>\n<\/ul>\n<p><small><br \/>\n*The follow-up period began 5 weeks or more after administration and consisted of a median follow-up of 5 years with a range of 1.7 to 5.2 years.<\/small><br \/>\n<sup>\u2020<\/sup><small>Median is the middle number in a list of numbers arranged from smallest to largest.<\/small><br \/>\n<sup>\u2021<\/sup><small>19 of 112 people (17%) returned to continuous prophylaxis after ROCTAVIAN, with a median start time at 984 (range: 33 to 1467) days. An ABR of 35 was added to account for the periods when these people were on prophylaxis regardless of the patients\u2019 actual bleed rate.<br \/>\n<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-690b393fe3438\" class=\"block call-to-action patient-story-cta\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n            <div class=\"box\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/dave-story-background-1024x266.png);\">\n                <div class=\"story-cta-inner\">z\n                                    <p class=\"quote\">It\u2019s possible to live with severe hemophilia A that may not include continuous prophylaxis.<\/p>\n                \n                                    <p class=\"citation\">&#8211; Dave N., received ROCTAVIAN in 2024. <br><small>ROCTAVIAN is indicated for adults only.<\/small><\/p>\n                \n                                    <img decoding=\"async\" class=\"mobile-image\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/dave-story-mobile.png?v=0.113\" alt=\"\" \/>                \n                                    <a href=\"https:\/\/www.roctavian.com\/en-us\/roctavian-stories\/#dave-N\" class=\"button\">WATCH DAVE&#8217;S STORY<\/a>\n                                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"prophylaxis-WT\" class=\"block wrapped-content block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fa3bde96961\" class=\"block-wysiwyg\">\n            <h2>You could be free from prophylaxis for years*<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-68fa3bde96b08\">\n    <div class=\"image image-responsive image-rounded image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_4-1900x896.png\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_4-1.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-68fa3bde96b41\" class=\"block-wysiwyg\">\n            <h4 style=\"text-align: center\">5 years after ROCTAVIAN, more than 70% of people (80 out of 112) had responded to ROCTAVIAN then stopped\u2014and stayed off\u2014continuous prophylaxis<sup>\u2021\u00a7<\/sup><\/h4>\n<ul>\n<li>Results are based on 112 people whose data were collected for at least 6 months before receiving ROCTAVIAN and compared with their data over the 5-year follow-up period<sup>\u2021<\/sup><\/li>\n<\/ul>\n<p>After ROCTAVIAN, your doctor will monitor your lab results and talk to you about whether you can stop prophylaxis and whether you should start prophylaxis again if stopped. In ROCTAVIAN clinical studies, patients who did not respond to treatment or lost response to treatment were able to resume prophylaxis.<\/p>\n<p>Your doctor will also discuss with you whether and how you should treat for any surgeries, procedures, injuries, or bleeds.<br \/>\n<small><br \/>\n*Prophylaxis is defined as the ongoing use of Factor VIII or another treatment to prevent bleeds.<br \/>\n<sup>\u2020<\/sup><small>The follow-up period began 5 weeks or more after administration and consisted of a median follow-up of 5 years with a range of 1.7 to 5.2 years.<\/small><br \/>\n<sup>\u2021<\/sup><small>Data were collected for 6 months, and those results were annualized.<\/small><br \/>\n<sup>\u00a7<\/sup>ROCTAVIAN worked for 71% (80\/112) of people in the rollover population and 59% (13\/22) of people in the directly enrolled population throughout the 5-year follow-up period.<br \/>\n<\/small><\/p>\n    <\/div>\n\n<figure id=\"acf-block-690a04db7d7c9\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/Screenshot-2025-11-04-at-13.50.06-e1763033622336.png?v=0.113\" alt=\"\" \/>            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Consistent-WT\" class=\"block wrapped-content block-zero-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fa3f94a583f\" class=\"block-wysiwyg\">\n            <h2>Health-related quality-of-life changes were measured over 5 years*<\/h2>\n<p>The Haemo-QoL-A (Haemophilia-Specific Quality of Life Questionnaire) is designed to measure health-related quality of life specifically for people with hemophilia<\/p>\n<ul>\n<li class=\"p1\">Haemo-QoL-A consists of a Total Score and 6 domain scores: Physical functioning, Role functioning, Consequences of bleeding, Worry, Emotional impact, and Treatment concern<\/li>\n<li class=\"p1\">Each domain measures specific aspects of HRQoL for people with hemophilia<\/li>\n<li class=\"p1\">Participants answer each question on a scale from 0, \u201cnone of the time,\u201d to 5, \u201call of the time.\u201d For analysis, this scale is averaged and converted to 0\u2013100, with higher scores indicating higher HRQoL or less impairment<\/li>\n<li class=\"p1\">Study limitations: The ROCTAVIAN Phase 3 study was a single-arm study, which may impact the interpretation of patient-reported outcome findings. The absence of a comparator arm may result in an under- or overestimation of treatment effect. Patient-reported nature of data may impact the reliability of findings. Since formal hypothesis testing was completed after the Year 2 data cutoff per the statistical analysis plan, all data reported here are for descriptive purposes<\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Consistent-WT\" class=\"block wrapped-content block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fa3f94a583f\" class=\"block-wysiwyg\">\n            <h4>Mean (SD) Haemo-QoL-A Total Score(n=112)<\/h4>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Consistent-WT\" class=\"block wrapped-content block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-68fa3f94a59ec\">\n    <div class=\"image image-responsive image-rounded image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_5-1900x522.png\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/1.1_5-1.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<figure id=\"acf-block-690a06e1b2c02\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/Screenshot-2025-11-04-at-13.50.06-e1763033622336.png?v=0.113\" alt=\"\" \/>            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Consistent-WT\" class=\"block wrapped-content block-tight-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-690bba186d74b\" class=\"block-wysiwyg\">\n            <h2>ROCTAVIAN clinical study details<\/h2>\n<h4>The longest and largest Phase 3 gene therapy clinical study in severe hemophilia A*<\/h4>\n    <\/div>\n\n<figure id=\"acf-block-6914687895d8a\">\n    <div class=\"image image-responsive image-rounded image-natural-size image-align-center\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/Group-8377.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/Group-8385.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-68fa441eb32fa\" class=\"block-wysiwyg\">\n            <p>Get <a href=\"https:\/\/www.roctavian.com\/en-us\/safety\/\">safety information<\/a> from the ROCTAVIAN clinical study.<\/p>\n<p><small>*At FDA approval, ROCTAVIAN had the longest and largest Phase 3 clinical study for gene therapy in severe hemophilia A.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68fbb5e310019\" class=\"block call-to-action call-to-action-no-overlay light-cta\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/lb-bg-OW-1024x404.jpg);\">\n\t\t\t\t<div class=\"overlay\"><\/div>\n\t\t\t\t<div class=\"cta-content\">\n\t\t\t\t    \t\t\t\t\t<div class=\"cta-content-main\">\n                        <div class=\"content-block\">\n\t\t\t\t\t        \t\t\t\t\t        \t\t\t\t\t\t        <h2 class=\"h3\">Want to find a healthcare team that is experienced with ROCTAVIAN?\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t\t        <p><span style=\"color: #000000\">Find a treatment center nearest you.<\/span><\/p>\n\t\t\t\t\t\t    \t\t\t\t\t    <\/div>\n\t\t\t\t\t                                <div class=\"content-block\">\n                                <p><a class=\"button button-ghost\" href=\"https:\/\/www.roctavian.com\/en-us\/doctor-finder\/\" target=\"_self\">SEARCH NOW<\/a><\/p>\n                            <\/div>\n\t\t\t\t\t                        <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-5416","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) Results in 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