{"id":1916,"date":"2023-10-04T16:14:00","date_gmt":"2023-10-04T14:14:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1916"},"modified":"2024-04-10T16:16:16","modified_gmt":"2024-04-10T14:16:16","slug":"42a-liecivo-emicizumab-hemlibra-pri-profylaxii-krvacania-u-pacientov-vo-vsetkych-vekovych-skupinach-s-hemofiliou-a-s-inhibitorom-faktora-viii","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/42a-liecivo-emicizumab-hemlibra-pri-profylaxii-krvacania-u-pacientov-vo-vsetkych-vekovych-skupinach-s-hemofiliou-a-s-inhibitorom-faktora-viii\/","title":{"rendered":"42A: Lie\u010divo emicizumab (Hemlibra) pri profylaxii krv\u00e1cania u pacientov vo v\u0161etk\u00fdch vekov\u00fdch skupin\u00e1ch s hemof\u00edliou A s inhib\u00edtorom faktora VIII"},"content":{"rendered":"
    \n
  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Hemof\u00edlia typu A je pomerne vz\u00e1cne nevylie\u010dite\u013en\u00e9 dedi\u010dn\u00e9 ochorenie postihuj\u00face predov\u0161etk\u00fdm mu\u017eov, ktor\u00e9 sa prejavuje poruchou zr\u00e1\u017eania krvi. Pacienti s hemof\u00edliou krv\u00e1caj\u00fa po poranen\u00ed alebo pri oper\u00e1cii dlh\u0161ie ako zdrav\u00ed \u013eudia. M\u00f4\u017ee u nich doch\u00e1dza\u0165 aj k spont\u00e1nnemu krv\u00e1caniu do k\u013abov alebo svalov, ktor\u00e9 sa objavuje bez zjavnej pr\u00ed\u010diny, \u010di po malom \u00faraze. V niektor\u00fdch pr\u00edpadoch m\u00f4\u017ee by\u0165 v\u0161ak krv\u00e1canie i \u017eivot ohrozuj\u00face, hlavne vtedy, ke\u010f zasahuje centr\u00e1lny nervov\u00fd syst\u00e9m, tr\u00e1viaci trakt alebo d\u00fdchacie cesty. U \u0165a\u017e\u0161\u00edch hemofilikov \u010dastokr\u00e1t doch\u00e1dza ku krv\u00e1caniu, ktor\u00e9 sa ozna\u010duje ako spont\u00e1nne, bez zjavnej pr\u00ed\u010diny. Pribli\u017ene u 30% pacientov sa vyvin\u00fa inhib\u00edtory proti faktoru VIII (FVIII), ktor\u00e9 neutralizuj\u00fa pod\u00e1van\u00fd FVIII a robia lie\u010dbu ne\u00fa\u010dinnou. <\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Hemlibra obsahuje lie\u010divo \u201eemicizumab\u201c. Patr\u00ed do skupiny liekov naz\u00fdvan\u00fdch \u201emonoklon\u00e1lne protil\u00e1tky\u201c. Monoklon\u00e1lne protil\u00e1tky s\u00fa typom bielkoviny, ktor\u00e1 rozpozn\u00e1 \u0161pecifick\u00fd cie\u013e v tele a navia\u017ee sa na\u0148. <\/p>\n\n\n\n

      Hemlibra obnovuje funkciu ch\u00fdbaj\u00faceho aktivovan\u00e9ho faktora VIII, ktor\u00fd je potrebn\u00fd na \u00fa\u010dinn\u00e9 zr\u00e1\u017eanie krvi. Hemlibra m\u00e1 \u0161trukt\u00faru odli\u0161n\u00fa od \u0161trukt\u00fary faktora VIII, a preto inhib\u00edtor faktora VIII nem\u00e1 vplyv na jej p\u00f4sobenie.<\/p>\n\n\n\n

      Hemlibra bol registrovan\u00fd v Eur\u00f3pskej \u00fanii pre hodnoten\u00fa indik\u00e1ciu vo febru\u00e1ri 2018.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n

        Odborn\u00edk zapojen\u00fd do hodnotena sa vyjadrili, \u017ee na Slovensku je s\u00fa\u010dasn\u00e1 lie\u010dba hemof\u00edlie A s inhib\u00edtorom FVIII v s\u00falade s najnov\u0161\u00edmi medzin\u00e1rodn\u00fdmi odpor\u00fa\u010daniami, av\u0161ak st\u00e1le ch\u00fdba kategoriz\u00e1cia nov\u00e9ho lie\u010diva emicizumab.<\/p>\n\n\n\n

          \n
        1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

          Dr\u017eite\u013e registr\u00e1cie (Roche Registration GmbH (DEU)) podal \u017eiados\u0165 o zaradenie lie\u010diva emicizumab (Hemlibra) pri profylaxii krv\u00e1cania u pacientov vo v\u0161etk\u00fdch vekov\u00fdch skupin\u00e1ch s hemof\u00edliou A s inhib\u00edtorom faktora VIII.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Hemlibra v predmetnej indik\u00e1ci\u00ed, nako\u013eko sp\u013a\u0148a legislat\u00edvnu podmienku n\u00e1kladovej efekt\u00edvnosti v popul\u00e1cii pacientov s hemof\u00edliou A s inhib\u00edtorom FVIII.<\/p>\n\n\n\n

          Z\u00e1rove\u0148 NIHO odpor\u00fa\u010da zv\u00e1\u017ei\u0165 \u00fapravu indika\u010dn\u00e9ho obmedzenia pod\u013ea n\u00e1vrhu NIHO.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Hemlibra v predmetnej indik\u00e1ci\u00ed, nako\u013eko…<\/p>","protected":false},"author":3,"featured_media":1828,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[80,79],"class_list":["post-1916","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-emicizumab","tag-hemlibra"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1916","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1916"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1916\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1828"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1916"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1916"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1916"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}