{"id":12176,"date":"2021-04-26T09:00:00","date_gmt":"2021-04-26T13:00:00","guid":{"rendered":"https:\/\/wfh.org\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/"},"modified":"2024-04-22T09:00:26","modified_gmt":"2024-04-22T13:00:26","slug":"uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/","title":{"rendered":"UniQure d\u00e9clare le d\u00e9veloppement d\u2019un carcinome h\u00e9patocellulaire dans un essai clinique de th\u00e9rapie g\u00e9nique"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"12176\" class=\"elementor elementor-12176 elementor-3195\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6a9166c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6a9166c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-cf9db1b\" data-id=\"cf9db1b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cc18d62 elementor-widget elementor-widget-text-editor\" data-id=\"cc18d62\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"\"><strong>Mise \u00e0 jour du 26 avril 2021<\/strong><\/p>\n<p class=\"\">uniQure vient d\u2019annoncer que la Food and Drug Administration (FDA) des \u00c9tats-Unis a lev\u00e9 la suspension clinique du programme de th\u00e9rapie g\u00e9nique pour l\u2019h\u00e9mophilie B du groupe, apr\u00e8s avoir d\u00e9termin\u00e9 que tous les probl\u00e8mes soulev\u00e9s par la FDA, en rapport avec un seul patient auquel on a diagnostiqu\u00e9 un carcinome h\u00e9patocelullaire (CHC) au sein de l\u2019essai pivot HOPE-B, ont \u00e9t\u00e9 r\u00e9solues. Consultez le communiqu\u00e9 de presse complet (en anglais)\u00a0<a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/07\/uniQure-Announces-FDA-Removes-Clinical-Hold-on-Hemophilia-B-Gene-Therapy-Program.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">ici<\/a>.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-56e20d0 elementor-widget elementor-widget-text-editor\" data-id=\"56e20d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"\"><strong>Mise \u00e0 jour du 23\u00a0d\u00e9cembre 2020<\/strong><\/p>\n<p class=\"\">BioMarin annonce l\u2019arr\u00eat temporaire de toute administration dans ses essais de th\u00e9rapie g\u00e9nique sur l\u2019h\u00e9mophilie de mani\u00e8re \u00e0 mieux comprendre le carcinome h\u00e9patocellulaire qui s\u2019est d\u00e9velopp\u00e9 chez un participant d\u2019UniQure atteint d\u2019h\u00e9mophilie\u00a0B<\/p>\n<p class=\"\">BioMarin a inform\u00e9 la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) de l\u2019arr\u00eat de toute administration afin de permettre l\u2019examen approfondi des informations disponibles sur le cas r\u00e9cemment rapport\u00e9 par UniQure d\u2019un participant \u00e0 un essai clinique ayant d\u00e9velopp\u00e9 un carcinome h\u00e9patocellulaire (CHC) et la clarification du lien \u00e9ventuel avec la th\u00e9rapie g\u00e9nique facteur\u00a0IX-AAV5 que le patient a re\u00e7ue. La pause fait r\u00e9f\u00e9rence aux essais ancillaires que BioMarin m\u00e8ne depuis la fin des administrations de valoctocog\u00e8ne roxaparvovec dans l\u2019essai de phase\u00a0III pivot AAV5-facteur\u00a0VIII. Les donn\u00e9es \u00e0 un an seront communiqu\u00e9es en d\u00e9but d\u2019ann\u00e9e. BioMarin a soulign\u00e9 que les administrations dans ses autres essais ont \u00e9t\u00e9 interrompues par exc\u00e8s de prudence, jusqu\u2019\u00e0 ce que l\u2019on en sache davantage sur le participant d\u2019UniQure et le r\u00f4le \u00e9ventuel de la th\u00e9rapie avec AAV dans le d\u00e9veloppement du carcinome h\u00e9patocellulaire.<\/p>\n<p class=\"\"><strong>Publication initiale du 21\u00a0d\u00e9cembre 2020<\/strong><\/p>\n<p class=\"\">UniQure, qui m\u00e8ne une \u00e9tude de th\u00e9rapie g\u00e9nique de phase\u00a0III sur le facteur\u00a0IX avec vecteur AAV5, signale ce jour un cas de carcinome h\u00e9patocellulaire (CHC) chez un participant \u00e0 l\u2019essai.<sup>1<\/sup>\u00a0Le CHC est une tumeur qui appara\u00eet dans le foie. La population des h\u00e9mophiles est \u00e0 risque de CHC en raison de l\u2019exposition ant\u00e9rieure aux virus de l\u2019h\u00e9patite\u00a0B et C (VHB, VHC) qui endommagent le foie, et ce risque perdure m\u00eame apr\u00e8s traitement et \u00e9limination de ces virus. Dans le cas pr\u00e9sent, ce participant pr\u00e9sentait des ant\u00e9c\u00e9dents d\u2019infections par le VHB et le VHC, trait\u00e9es et r\u00e9solues. UniQure indique que le participant est atteint d\u2019une st\u00e9atose h\u00e9patique non alcoolique, affection fr\u00e9quente qui constitue \u00e9galement un facteur de risque pour le CHC. Les taux d\u2019enzymes h\u00e9patiques ne sont pas \u00e9lev\u00e9s. La contribution de l\u2019AAV5 au carcinome h\u00e9patocellulaire qui s\u2019est d\u00e9velopp\u00e9 n\u2019est pas connue, mais sera \u00e9valu\u00e9e au cours des prochains mois apr\u00e8s ablation de la tumeur et analyse mol\u00e9culaire.\u00a0\u00c0 ce stade, l\u2019on ne conna\u00eet pas l\u2019\u00e9tat de sant\u00e9 h\u00e9patique du patient avant le traitement de son h\u00e9patite\u00a0C (pr\u00e9sence ou non d\u2019une fibrose ou d\u2019une cirrhose avanc\u00e9e) ni le g\u00e9notype de son HCV.<\/p>\n<p class=\"\">Bien que l\u2019AAV soit consid\u00e9r\u00e9 comme un vecteur viral non int\u00e9gratif, ce qui signifie qu\u2019il ne p\u00e9n\u00e8tre pas de mani\u00e8re permanente dans les chromosomes des cellules, ce n\u2019est pas vrai.<sup>2,3<\/sup>\u00a0L\u2019AAV s\u2019int\u00e8gre \u00e0 un faible niveau par rapport \u00e0 la dose totale de g\u00e9nomes de vecteur administr\u00e9e. Cependant, lorsque sont administr\u00e9es des doses totales de l\u2019ordre du quadrillion (1\u00a0suivi de 15\u00a0z\u00e9ros), une int\u00e9gration de faible niveau r\u00e9sulte n\u00e9anmoins en des dizaines de millions d\u2019int\u00e9grations par foie. Par cons\u00e9quent,\u00a0<u>tous<\/u>\u00a0les receveurs d\u2019AAV pr\u00e9sentent des \u00e9v\u00e9nements d\u2019int\u00e9gration. Que ces int\u00e9grations puissent \u00eatre ou non \u00e0 l\u2019origine d\u2019une maladie est une autre question.<sup>3,4<\/sup>\u00a0\u00c9tant donn\u00e9 que ce CHC est la premi\u00e8re tumeur maligne d\u00e9couverte parmi les centaines de participants aux essais cliniques sur les AAV dans l\u2019h\u00e9mophilie et d\u2019autres pathologies, le risque d\u2019une int\u00e9gration dommageable pr\u00e9judiciable dans les chromosomes semble extr\u00eamement faible. Cependant, les r\u00e9sultats r\u00e9cemment pr\u00e9sent\u00e9s de la th\u00e9rapie g\u00e9nique \u00e0 long terme sur le facteur\u00a0VIII avec vecteur AAV chez le chien indiquaient qu\u2019une expansion clonale des h\u00e9patocytes \u00e9tait possible, ce qui peut sugg\u00e9rer une \u00e9tape vers le d\u00e9veloppement d\u2019un CHC.<sup>3<\/sup><\/p>\n<p class=\"\">Le docteur Glenn Pierce, vice-pr\u00e9sident de la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie en charge des affaires m\u00e9dicales a d\u00e9clar\u00e9 qu\u2019\u00ab\u00a0il restait \u00e0 d\u00e9terminer comment la th\u00e9rapie facteur\u00a0IX-AAV5 pouvait \u00e9ventuellement contribuer aux autres facteurs de risque de ce participant pour la carcinogen\u00e8se. L\u2019analyse mol\u00e9culaire de la tumeur extraite sera r\u00e9v\u00e9latrice et pourrait permettre de d\u00e9terminer la contribution \u00e9ventuelle de l\u2019int\u00e9gration de l\u2019AAV au d\u00e9veloppement du carcinome h\u00e9patocellulaire de ce participant. Ce cas met en \u00e9vidence la n\u00e9cessit\u00e9 d\u2019\u00e9tablir un registre mondial visant \u00e0 surveiller les \u00e9v\u00e9nements ind\u00e9sirables rares \u00e0 distance de l\u2019administration de la th\u00e9rapie g\u00e9nique.\u00a0\u00bb<\/p>\n<p class=\"\">Pour lire le communiqu\u00e9 de presse complet d\u2019UniQure,\u00a0<a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/07\/2020-12-21-uniQure-Press-Release.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">cliquez ici<\/a>.<\/p>\n<ol>\n<li><a href=\"https:\/\/tools.eurolandir.com\/tools\/Pressreleases\/GetPressRelease\/?ID=3852484&amp;lang=en-GB&amp;companycode=nl-qure&amp;v=\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/tools.eurolandir.com\/tools\/Pressreleases\/GetPressRelease\/?ID=3852484&amp;lang=en-GB&amp;companycode=nl-qure&amp;v=<\/a>\u00a0Derni\u00e8re consultation le 21\u00a0d\u00e9cembre 2020<\/li>\n<li>Gil-Farina I, Fronza R, Kaeppel C, Lopez-Franco E, Ferreira V, D\u2019Avola D, Benito A, Prieto J, Petry H, Gonzalez-Aseguinolaza G, Schmidt M.\u00a0<a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/26948440\/\" target=\"_blank\" rel=\"noopener noreferrer\">Recombinant AAV Integration Is Not Associated With Hepatic Genotoxicity in Nonhuman Primates and Patients.\u00a0<\/a>Mol Ther. 2016 Jun;24(6):1100-1105. doi: 10.1038\/mt.2016.52.<\/li>\n<li>Nguyen GN, Everett JK, Kafle S, Roche AM, Raymond HE, Leiby J, Wood C, Assenmacher CA, Merricks EP, Long CT, Kazazian HH, Nichols TC, Bushman FD, Sabatino DE. A long-term study of AAV gene therapy in dogs with hemophilia A identifies clonal expansions of transduced liver cells. Nat Biotechnol. 2020 Nov 16. doi: 10.1038\/s41587-020-0741-7.<\/li>\n<li>Kang HR, Gjorgjieva M, Smith SN, Brooks ED, Chen Z, Burgess SM, Chandler RJ, Waskowicz LR, Grady KM, Li S, Mithieux G, Venditti CP, Rajas F, Koeberl DD. Pathogenesis of Hepatic Tumors following Gene Therapy in Murine and Canine Models of Glycogen Storage Disease. Mol Ther Methods Clin Dev. 2019 Nov 11;15:383-391. doi: 10.1016\/j.omtm.2019.10.016.<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>uniQure vient d\u2019annoncer que la Food and Drug Administration (FDA) des \u00c9tats-Unis a lev\u00e9 la suspension clinique du programme de th\u00e9rapie g\u00e9nique pour l\u2019h\u00e9mophilie B du groupe, apr\u00e8s avoir d\u00e9termin\u00e9 que tous les probl\u00e8mes soulev\u00e9s par la FDA, en rapport avec un seul patient auquel on a diagnostiqu\u00e9 un carcinome h\u00e9patocelullaire (CHC) au sein de l\u2019essai pivot HOPE-B, ont \u00e9t\u00e9 r\u00e9solues.<\/p>\n","protected":false},"author":3,"featured_media":19564,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[177,197],"tags":[],"search-category":[85],"class_list":["post-12176","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite-medicale","category-declarations-publiques-et-recommandations-de-la-fmh","search-category-article"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UniQure d\u00e9clare le d\u00e9veloppement d\u2019un carcinome h\u00e9patocellulaire dans un essai clinique de th\u00e9rapie g\u00e9nique | FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UniQure d\u00e9clare le d\u00e9veloppement d\u2019un carcinome h\u00e9patocellulaire dans un essai clinique de th\u00e9rapie g\u00e9nique\" \/>\n<meta property=\"og:description\" content=\"uniQure vient d\u2019annoncer que la Food and Drug Administration (FDA) des \u00c9tats-Unis a lev\u00e9 la suspension clinique du programme de th\u00e9rapie g\u00e9nique pour l\u2019h\u00e9mophilie B du groupe, apr\u00e8s avoir d\u00e9termin\u00e9 que tous les probl\u00e8mes soulev\u00e9s par la FDA, en rapport avec un seul patient auquel on a diagnostiqu\u00e9 un carcinome h\u00e9patocelullaire (CHC) au sein de l\u2019essai pivot HOPE-B, ont \u00e9t\u00e9 r\u00e9solues.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/\" \/>\n<meta property=\"og:site_name\" content=\"FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/wfhemophilia\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-04-26T13:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-22T13:00:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/Placeholder-Result-V1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Electra Rozakis\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Electra Rozakis\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/\"},\"author\":{\"name\":\"Electra Rozakis\",\"@id\":\"https:\/\/wfh.org\/fr\/#\/schema\/person\/622f4b0ed56b8e4a987dd20bef774887\"},\"headline\":\"UniQure d\u00e9clare le d\u00e9veloppement d\u2019un carcinome h\u00e9patocellulaire dans un essai clinique de th\u00e9rapie g\u00e9nique\",\"datePublished\":\"2021-04-26T13:00:00+00:00\",\"dateModified\":\"2024-04-22T13:00:26+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/\"},\"wordCount\":1098,\"publisher\":{\"@id\":\"https:\/\/wfh.org\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/Placeholder-Result-V1.png\",\"articleSection\":[\"Actualit\u00e9 m\u00e9dicale\",\"D\u00e9clarations publiques et recommandations de la FMH\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/\",\"url\":\"https:\/\/wfh.org\/fr\/article\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/\",\"name\":\"UniQure d\u00e9clare le d\u00e9veloppement d\u2019un carcinome h\u00e9patocellulaire dans un essai clinique de th\u00e9rapie g\u00e9nique | FMH - 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