{"id":4693,"date":"2026-10-20T23:05:57","date_gmt":"2026-10-21T03:05:57","guid":{"rendered":"https:\/\/canasanta.ca\/?p=4693"},"modified":"2026-10-20T23:05:57","modified_gmt":"2026-10-21T03:05:57","slug":"fda-hibsago-hepatitis-b-tratamiento-2026","status":"publish","type":"post","link":"https:\/\/canasanta.ca\/en\/salud\/fda-hibsago-hepatitis-b-tratamiento-2026\/","title":{"rendered":"LA FDA ABRE UNA PUERTA CONTRA LA HEPATITIS B CR\u00d3NICA"},"content":{"rendered":"

La FDA aprob\u00f3 Hibsago (bepirovirsen), el primer oligonucle\u00f3tido antisentido autorizado en Estados Unidos contra la hepatitis B cr\u00f3nica. Para determinados pacientes, el tratamiento abre una posibilidad que hasta ahora era excepcional: mantener el virus controlado despu\u00e9s de suspender toda la terapia.<\/h3>\n

La decisi\u00f3n fue anunciada este 20 de octubre por la Administraci\u00f3n de Alimentos y Medicamentos de Estados Unidos y confirmada por Reuters. El medicamento, desarrollado por GSK a partir de tecnolog\u00eda licenciada de Ionis Pharmaceuticals, se administra junto con el tratamiento antiviral existente y est\u00e1 dirigido a un grupo espec\u00edfico de adultos sin cirrosis.<\/p>\n

<\/div>\n

Una aprobaci\u00f3n de primera clase<\/strong><\/h2>\n

Hibsago, cuyo principio activo es bepirovirsen, es el primer oligonucle\u00f3tido antisentido aprobado por la FDA para tratar la hepatitis B cr\u00f3nica. Este tipo de medicamento est\u00e1 dise\u00f1ado para reconocer el ARN del virus e interferir con la producci\u00f3n de componentes virales que ayudan a mantener la infecci\u00f3n.<\/p>\n

La autorizaci\u00f3n cubre a adultos sin cirrosis que lleven al menos seis meses recibiendo terapia antiviral, tengan el ADN del virus suprimido y presenten niveles del ant\u00edgeno de superficie de hepatitis B iguales o inferiores a 3.000 IU\/mL, determinados mediante una prueba autorizada por la FDA.<\/p>\n

<\/div>\n

Uno de cada cinco logr\u00f3 control sin tratamiento<\/strong><\/h2>\n

La aprobaci\u00f3n se apoy\u00f3 en los ensayos de fase III B-Well. Seg\u00fan la FDA y GSK, alrededor del 19% de los pacientes del grupo indicado alcanz\u00f3 una respuesta considerada cura funcional: el ADN viral y el ant\u00edgeno de superficie permanecieron indetectables durante al menos 24 semanas despu\u00e9s de suspender todo el tratamiento.<\/p>\n

El resultado no significa que la hepatitis B haya sido erradicada del organismo ni que todos los pacientes puedan abandonar sus medicamentos. La posibilidad de suspender la terapia depende de criterios cl\u00ednicos y de laboratorio y debe realizarse bajo supervisi\u00f3n m\u00e9dica.<\/p>\n

<\/div>\n

Una infecci\u00f3n que suele exigir a\u00f1os de terapia<\/strong><\/h2>\n

Los antivirales actuales pueden mantener el virus suprimido y reducir el riesgo de da\u00f1o hep\u00e1tico, pero muchas personas necesitan tomarlos durante a\u00f1os o de manera indefinida. La FDA destac\u00f3 precisamente que la nueva opci\u00f3n podr\u00eda permitir que algunos pacientes mantengan el control viral despu\u00e9s de terminar el tratamiento.<\/p>\n

GSK calcula que aproximadamente 1,7 millones de personas viven con hepatitis B cr\u00f3nica en Estados Unidos. La infecci\u00f3n persistente puede provocar cirrosis, insuficiencia hep\u00e1tica y c\u00e1ncer de h\u00edgado.<\/p>\n

<\/div>\n

El l\u00edmite de la noticia<\/strong><\/h2>\n

La aprobaci\u00f3n representa un avance terap\u00e9utico importante, pero no equivale a una cura universal. En los estudios, la mayor\u00eda de los pacientes no alcanz\u00f3 la respuesta funcional sostenida. Hibsago tampoco est\u00e1 autorizado para cualquier persona con hepatitis B: la indicaci\u00f3n exige condiciones precisas y excluye a pacientes con cirrosis.<\/p>\n

El medicamento ya hab\u00eda recibido autorizaci\u00f3n en Jap\u00f3n y contin\u00faa bajo revisi\u00f3n regulatoria en Europa y China. La decisi\u00f3n estadounidense convierte ahora a esta estrategia dirigida al ARN en una nueva herramienta cl\u00ednica contra una de las infecciones virales cr\u00f3nicas m\u00e1s extendidas del mundo.<\/p>","protected":false},"excerpt":{"rendered":"

La FDA aprueba Hibsago, primer tratamiento antisentido contra la hepatitis B cr\u00f3nica; cerca de uno de cada cinco pacientes seleccionados mantuvo control viral tras suspender la terapia.<\/p>","protected":false},"author":284226809,"featured_media":4694,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_wpcom_ai_launchpad_first_post":false,"_jetpack_hide_featured_image":false,"_jetpack_featured_image_duplicate_dismissed":0,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[33205457,2127],"tags":[33207323,33205885,33207324,33207322],"class_list":["post-4693","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-al-dia","category-salud","tag-bepirovirsen","tag-fda","tag-hepatitis-b","tag-hibsago"],"acf":{"introduccion":"","fuentes_y_referencias":"

U.S. Food and Drug Administration (FDA)<\/strong>, 20 de octubre de 2026 \u2014 aprobaci\u00f3n de Hibsago (bepirovirsen) para hepatitis B cr\u00f3nica.<\/p>

Reuters<\/strong>, 20 de octubre de 2026 \u2014 cobertura de la aprobaci\u00f3n y resultados cl\u00ednicos.<\/p>

GSK<\/strong> \u2014 informaci\u00f3n cl\u00ednica y regulatoria sobre bepirovirsen.<\/p>","autor":[748]},"yoast_head":"\nLA FDA ABRE UNA PUERTA CONTRA LA HEPATITIS B CR\u00d3NICA - Ca\u00f1asanta<\/title>\n<meta name=\"description\" content=\"La FDA aprueba Hibsago, primer tratamiento antisentido contra la hepatitis B cr\u00f3nica; algunos pacientes lograron mantener el virus controlado sin terapia.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/canasanta.ca\/en\/health\/fda-hibsago-hepatitis-b-tratamiento-2026\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"LA FDA ABRE UNA PUERTA CONTRA LA HEPATITIS B CR\u00d3NICA\" \/>\n<meta property=\"og:description\" content=\"La FDA aprueba Hibsago, primer tratamiento antisentido contra la hepatitis B cr\u00f3nica; algunos 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