{"id":15028,"date":"2021-02-22T09:00:00","date_gmt":"2021-02-22T14:00:00","guid":{"rendered":"https:\/\/wfh.org\/actualizacion-sobre-fitusiran-posterior-al-congreso-eahad-2021\/"},"modified":"2024-04-22T09:36:29","modified_gmt":"2024-04-22T13:36:29","slug":"actualizacion-sobre-fitusiran-posterior-al-congreso-eahad-2021","status":"publish","type":"post","link":"https:\/\/wfh.org\/es\/article\/actualizacion-sobre-fitusiran-posterior-al-congreso-eahad-2021\/","title":{"rendered":"Actualizaci\u00f3n sobre fitusir\u00e1n, posterior al Congreso EAHAD 2021"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"15028\" class=\"elementor elementor-15028 elementor-4232\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8ee33ba elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8ee33ba\" data-element_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-dccdad4\" data-id=\"dccdad4\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-9330efc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9330efc\" data-element_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-33 elementor-inner-column elementor-element elementor-element-9d2d85b\" data-id=\"9d2d85b\" data-element_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-016a3a1 elementor-widget elementor-widget-image\" data-id=\"016a3a1\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 25-07-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"620\" height=\"400\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/WFH-international-logo-620x400-1.gif\" class=\"attachment-large size-large wp-image-1335\" alt=\"\" \/>\t\t\t\t\t\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<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-0a5ef92\" data-id=\"0a5ef92\" data-element_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-7b76ace elementor-widget elementor-widget-image\" data-id=\"7b76ace\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"620\" height=\"400\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/NHF-logo-620x400-1.jpg\" class=\"attachment-large size-large wp-image-1338\" alt=\"\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/NHF-logo-620x400-1.jpg 620w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/NHF-logo-620x400-1-300x194.jpg 300w\" sizes=\"(max-width: 620px) 100vw, 620px\" \/>\t\t\t\t\t\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<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-a2bc8ba\" data-id=\"a2bc8ba\" data-element_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-b7b8b4d elementor-widget elementor-widget-image\" data-id=\"b7b8b4d\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"620\" height=\"400\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/EHC_620x400.png\" class=\"attachment-large size-large wp-image-1341\" alt=\"\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/EHC_620x400.png 620w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/EHC_620x400-300x194.png 300w\" sizes=\"(max-width: 620px) 100vw, 620px\" \/>\t\t\t\t\t\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 class=\"elementor-element elementor-element-f92f64f elementor-widget elementor-widget-text-editor\" data-id=\"f92f64f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 25-07-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p class=\"\">El 30 de octubre de 2020, en respuesta a informes de acontecimientos tromb\u00f3ticos vasculares no mortales ocurridos en el ensayo cl\u00ednico con fitusir\u00e1n para pacientes adolescentes y adultos con hemofilia A\/B con y sin inhibidores, el patrocinador suspendi\u00f3 temporalmente de manera voluntaria la dosificaci\u00f3n para todos los pacientes participantes en los estudios cl\u00ednicos en curso. V\u00e9ase la declaraci\u00f3n conjunta de la\u00a0<a href=\"https:\/\/wfh.org\/es\/sanofi-genzyme-suspende-a-nivel-mundial-la-dosificacion-en-los-ensayos-de-fitusiran-a-fin-de-investigar-nuevos-efectos-adversos\/\" target=\"_blank\" rel=\"noopener noreferrer\">FMH<\/a>, el\u00a0<a href=\"https:\/\/www.ehc.eu\/wfh-ehc-nhf-joint-statement-on-global-dosing-hold-in-fitusiran-trials-initiated-by-sanofi-genzyme-to-investigate-new-adverse-events\/\" target=\"_blank\" rel=\"noopener noreferrer\">EHC<\/a>\u00a0y la\u00a0<a href=\"https:\/\/www.hemophilia.org\/news\/global-dosing-hold-in-fitusiran-trials-initiated-by-sanofi-genzyme-to-investigate-new-adverse-events\" target=\"_blank\" rel=\"noopener noreferrer\">NHF<\/a>.<\/p>\r\n\r\n<p class=\"\">En total se han presentado cinco acontecimientos. Los primeros dos acontecimientos se reportaron anteriormente. El primero fue una trombosis de senos venosos cerebrales inicialmente diagnosticada como hemorragia cerebral, que dio lugar al uso concomitante de una cantidad considerable de concentrado de factor, y desemboc\u00f3 en un resultado mortal. El segundo fue una trombosis auricular posterior al uso concomitante de un agente de desv\u00edo (rFVIIa). Estos acontecimientos se relacionaron con el uso de dosis de concentrados de factor de coagulaci\u00f3n o agentes de desv\u00edo en cantidades superiores a las establecidas por las actuales gu\u00edas para el tratamiento de hemorragias intraterap\u00e9uticas.<\/p>\r\n\r\n<p class=\"\">Los tres acontecimientos m\u00e1s recientes, que dieron lugar a la suspensi\u00f3n temporal de la dosificaci\u00f3n en octubre de 2020, abarcan un infarto cerebral, un accidente cerebrovascular y un trastorno vascular vertebral (posible trombosis relacionada con una lesi\u00f3n vertebral), a pesar de la observancia de las gu\u00edas para el tratamiento de hemorragias intraterap\u00e9uticas. La evaluaci\u00f3n de estos cinco eventos apunta a que el riesgo de eventos tromb\u00f3ticos vasculares podr\u00eda ser mayor cuando los niveles de antitrombina (AT) se reducen por debajo del 10% de los niveles normales. Por ende, el estudio ahora se orientar\u00e1 a lograr niveles de AT de entre 15% y 35%, buscando mantener un equilibrio riesgo-beneficio favorable para los pacientes.<\/p>\r\n\r\n<p class=\"\">En enero de 2021, autoridades reguladoras mundiales evaluaron un plan de dosificaci\u00f3n modificado, el cual fue aprobado por la Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA, por su sigla en ingl\u00e9s), y por la Agencia Japonesa de Productos Farmac\u00e9uticos y Dispositivos M\u00e9dicos (PMDA, por su sigla en ingl\u00e9s). Despu\u00e9s de la revisi\u00f3n por parte de autoridades de salud, de consejos de revisi\u00f3n internacionales (IRB, por su sigla en ingl\u00e9s) y de un nuevo consentimiento de los pacientes, la dosificaci\u00f3n del fitusir\u00e1n se reanudar\u00e1 pa\u00eds por pa\u00eds. Durante el Congreso de la Asociaci\u00f3n Europea para la Hemofilia y Trastornos Afines (EAHAD, por su sigla en ingl\u00e9s), a principios de febrero de 2021, Sanofi present\u00f3 su propuesta de r\u00e9gimen modificado de dosificaci\u00f3n de fitusir\u00e1n para mitigar el riesgo de trombosis vascular.<\/p>\r\n\r\n<p class=\"\">No hay cambios en las gu\u00edas para el tratamiento de hemorragias durante la profilaxis con fitusir\u00e1n.<\/p>\r\n\r\n<p class=\"\">Reportamos esta informaci\u00f3n, que es del dominio p\u00fablico, y continuaremos manteniendo a nuestras comunidades informadas sobre otros acontecimientos relevantes.<\/p>\r\n\r\n<p class=\"\">El fitusir\u00e1n es uno de los agentes reequilibrantes en desarrollo cl\u00ednico. El objetivo de estos agentes, que abarcan anticuerpos anti-IVFT y un inhibidor de la prote\u00edna C activada, es hacer al sistema de coagulaci\u00f3n m\u00e1s procoagulante, a fin de compensar el defecto de la coagulaci\u00f3n en la hemofilia A\/B. En algunos ensayos cl\u00ednicos con anti-IVFT tambi\u00e9n se han presentado eventos tromb\u00f3ticos en un peque\u00f1o n\u00famero de participantes. Por tanto, es extremadamente importante una cuidadosa selecci\u00f3n de las dosis y un cuidadoso uso de los concentrados de factor de coagulaci\u00f3n durante hemorragias intraterap\u00e9uticas.<\/p>\r\n\r\n<p class=\"\">Para leer el texto completo del comunicado de prensa (en ingl\u00e9s) haga\u00a0<a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/07\/Fitusiran-EAHAD-Media-update.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">clic aqu\u00ed<\/a>.<\/p>\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>El 30 de octubre de 2020, en respuesta a informes de acontecimientos tromb\u00f3ticos vasculares no mortales ocurridos en el ensayo cl\u00ednico con fitusir\u00e1n para pacientes adolescentes y adultos con hemofilia A\/B con y sin inhibidores.<\/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":[196],"tags":[],"search-category":[320],"class_list":["post-15028","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias-medicas","search-category-article-es"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.4 (Yoast SEO v23.4) - 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