{"id":3296,"date":"2025-10-27T13:17:41","date_gmt":"2025-10-27T13:17:41","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/?page_id=3296"},"modified":"2025-12-15T13:12:36","modified_gmt":"2025-12-15T13:12:36","slug":"starting-patients","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/starting-patients\/","title":{"rendered":"Starting Patients"},"content":{"rendered":"<div id=\"acf-block-69121c24a748b\" class=\"hero hero-roctavian\">\n    <div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/11\/starting-scaled-e1763381157364.png?v=1.49);\"><\/div>\n    <div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/11\/HCP_3.0-STARTING-PATIENTS_MOBILE.png?v=1.49);\"><\/div>\n    <div class=\"overlay\"><\/div>\n\n    <div class=\"hero-content\">\n        <div class=\"title-area\">\n                            <h1>STARTING PATIENTS ON ROCTAVIAN\n<\/h1>\n                                <\/div>\t\t\n                    <div class=\"text-area\">\n                <div class=\"text-area-content\">\n                                        <div class=\"text\">\n                        <p>Our team of experts is here to help every step of the way<\/p>\n                    <\/div>\n                                                                <div class=\"cta\">\n                                                                                    <p><a class=\"button\" href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/connect-with-us\/\" target=\"_self\">Connect with Us<\/a><\/p>\n                        <\/div>\n                                    <\/div>\n            <\/div>\n                            <div class=\"image-caption\">\n                <p class=\"p1\">Andrew W., dosed with ROCTAVIAN in 2018 as part of a clinical trial.<\/p>\n            <\/div>\n\n            <div class=\"additional-caption\">\n                            <\/div>\n            <\/div>\n<\/div>\n\n\n<div id=\"acf-block-68ff79236a651\" class=\"block boxed-content\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\">\n\t\t\t\t                    <h2>3 steps to start the journey with ROCTAVIAN\n&nbsp;\n&nbsp;\n<\/h2>\n                \t\t\t\t\n<div id=\"acf-block-68ff79236a8f0\" class=\"image-text-block content-align-center\">\n            <div class=\"image-block small\">\n            <figure>\n                <div class=\"image image-rounded\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/07\/4.1_Step-1-icon.png?v=1.49\" alt=\"Step 1\" \/>                <\/div>\n            <\/figure>\n        <\/div>\n        <div class=\"content-block\">\n                    <p style=\"color: #571e4c\"><strong>Conduct required eligibility testing<sup>1<\/sup><\/strong><\/p>\n                            <ul>\n<li>Bloodwork (AAV5 DetectCDx\u2122, liver function tests, Factor VIII inhibitor titer test)<\/li>\n<li>Liver ultrasound and elastography or laboratory assessments for determining hepatic fibrosis<\/li>\n<\/ul>\n                    <\/div>\n<\/div>\n\n<div id=\"acf-block-68ff79236a960\" class=\"image-text-block content-align-center\">\n            <div class=\"image-block small\">\n            <figure>\n                <div class=\"image image-rounded\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/07\/4.1_Step-2-icon.png?v=1.49\" alt=\"Step 2\" \/>                <\/div>\n            <\/figure>\n        <\/div>\n        <div class=\"content-block\">\n                    <p style=\"color: #571e4c\"><strong>Discuss lifestyle, safety considerations, and monitoring<sup>1<\/sup><\/strong><\/p>\n                            <ul>\n<li>Confirm the decision to treat with ROCTAVIAN<\/li>\n<\/ul>\n                    <\/div>\n<\/div>\n\n<div id=\"acf-block-68ff79236a9c9\" class=\"image-text-block content-align-center\">\n            <div class=\"image-block small\">\n            <figure>\n                <div class=\"image image-rounded\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/07\/4.1_Step-3-icon.png?v=1.49\" alt=\"Step 3\" \/>                <\/div>\n            <\/figure>\n        <\/div>\n        <div class=\"content-block\">\n                    <p style=\"color: #571e4c\"><strong>Ensure required forms are complete<\/strong><\/p>\n                            <ul>\n<li><a href=\"https:\/\/www.biomarin-rareconnections.com\/hcp\/roctavian\/enroll-your-patients\/\" target=\"_blank\" rel=\"noopener\">Patient Enrollment Form (PEF)<\/a>: HCP to complete<\/li>\n<li><a href=\"https:\/\/www.biomarin-rareconnections.com\/hcp\/wp-content\/uploads\/2025\/05\/ROC-Patient-Consent-Form-1.pdf\" target=\"_blank\" rel=\"noopener\">Patient Consent Form (PCF)<\/a>: patient to complete<\/li>\n<\/ul>\n                    <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-68ff79236aa04\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68ff79236aa20\" class=\"block-wysiwyg\">\n            <p>Patients may be eligible for financial support services with <a href=\"http:\/\/biomarin-rareconnections.com\">BioMarin RareConnections\u2122<\/a>.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68ff79236acd0\" class=\"block call-to-action dark-cta\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\" style=\"\">\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\">Administration of ROCTAVIAN does not eliminate the ability to return to prophylaxis<sup>1<\/sup>\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t\t        <p>In the clinical trial, some patients had increased Factor VIII activity levels but it was determined that they had not responded or lost response to ROCTAVIAN. These patients returned to prophylaxis.<\/p>\n\t\t\t\t\t\t    \t\t\t\t\t    <\/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>\n\n<div id=\"acf-block-68ff79236ad12\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68ff79236ad2f\" class=\"block-wysiwyg\">\n            <h2>Appropriate patients<\/h2>\n<p>The following eligibility criteria must be met before a patient can be considered for ROCTAVIAN<sup>1<\/sup>:<\/p>\n    <\/div>\n\n<figure id=\"acf-block-68ff79236aee8\">\n    <div class=\"image image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/10\/3.0_Appropriate-patients_chart-cropped.png?v=1.49\" alt=\"Table containing information on appropriate patients\" \/>            <\/div>\n            <figcaption><p>AAV5 DetectCDx\u2122 is a trademark of ARUP Laboratories.<\/p>\n<\/figcaption>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68ff79236af21\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68ff79236af3e\" class=\"block-wysiwyg\">\n            <h2>Identify and test your eligible patients early<\/h2>\n<p>AAV5 seropositivity increases with age and seroconversion can occur over time<sup>2<\/sup><\/p>\n    <\/div>\n\n<figure id=\"acf-block-68ff79236af79\">\n    <div class=\"image image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/10\/3.0_Identify-and-test.png?v=1.49\" alt=\"A graph that outlines how seroconversion can occur over time\" \/>            <\/div>\n            <figcaption><p>Klamroth R, et al. Hum Gene Ther. 2022;33(7-8):432-441.<\/p>\n<\/figcaption>\n    <\/figure>\n\n<div id=\"acf-block-68ff79236af96\" class=\"block-wysiwyg\">\n            <p>Data from Global seroprevalence of pre-existing immunity against AAV5 and other AAV serotypes in people with hemophilia A, a global, prospective, noninterventional study to determine the prevalence of pre-existing immunity against AAV2, AAV5, AAV6, AAV8, and AAVrh10 among people aged \u226512 years with hemophilia A and residual Factor VIII levels \u22642 IU\/dL (N=546).<sup>2<\/sup><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68ff79236afc6\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68ff79236afe0\" class=\"block-wysiwyg\">\n            <h2>Routine follow-ups show the impact of ROCTAVIAN<sup>1<\/sup><\/h2>\n<p>Monitoring Factor VIII activity and ALT levels<\/p>\n    <\/div>\n\n<figure id=\"acf-block-69121c24a7b7f\">\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:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/11\/Group-8199.png?v=1.49\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/11\/Monitoring-Factor-VIII_mobile.png?v=1.49\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-68ff79236afff\" class=\"block-wysiwyg\">\n            <ul>\n<li>Monitoring of ALT may be accompanied by monitoring of AST and CPK to rule out alternative causes for ALT elevations (including potentially hepatotoxic medications or agents, alcohol consumption, or strenuous exercise)<\/li>\n<li>Consider more frequent monitoring in patients with Factor VIII activity levels \u22645 IU\/dL and evidence of bleeding, taking into account the stability of Factor VIII levels since their previous measurement<\/li>\n<li>Weekly monitoring is recommended during corticosteroid tapering<sup>\u2020<\/sup><\/li>\n<\/ul>\n    <\/div>\n\n<div id=\"acf-block-68ff79236b020\" class=\"block-wysiwyg\">\n            <p><small>*Institute corticosteroid treatment in response to ALT elevations as required. Continue to monitor ALT until it returns to baseline. Monitor Factor VIII activity levels, since ALT elevation may be accompanied by a decrease in Factor VIII activity.<br \/>\n<sup>\u2020<\/sup>Agents that may reduce or increase the plasma concentration of corticosteroids (eg, agents that induce or inhibit cytochrome P450 3A4) can decrease the efficacy of the corticosteroid regimen or increase their side effects.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-69121c24a7e53\" class=\"block single-stacked-video\" data-muted-autoplay=\"false\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n            \n                            <h2 class=\"h3\">\u201cFor about 6 months post-infusion, I had weekly blood tests to make sure that all the levels of my liver were looking good and healthy.\u201d\n<\/h2>\n                                        <div class=\"supporting-text\">\n                    <h4>\u2014Dave N., dosed with ROCTAVIAN in 2024<\/h4>\n                <\/div>\n                        \n            <div class=\"video-poster\">\n                <a class=\"modal-video permitted\" href=\"https:\/\/player.vimeo.com\/video\/1136214532\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/10\/3.0_David_N_Photo.png?v=1.49);\">Play<\/a>\n            <\/div>\n            \n                            <p><a class=\"button\" href=\"https:\/\/player.vimeo.com\/video\/1136214532\" target=\"_self\">Watch his story<\/a><\/p>            \n                    <\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-68ff79236b332\" class=\"block call-to-action dark-cta\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\" style=\"\">\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 refer a patient who is eligible for ROCTAVIAN?\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t\t        <p>See the steps to referring patients to a dosing hemophilia treatment center.<\/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 button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/referring-patients\/\" target=\"_self\">REFER A PATIENT<\/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":5,"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-3296","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>Starting Patients | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) for Healthcare Professionals<\/title>\n<meta name=\"description\" content=\"How to get your patients started with ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) including eligibility testing, patient identification, and monitoring via routine follow-ups\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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