{"id":1918,"date":"2023-10-04T16:16:00","date_gmt":"2023-10-04T14:16:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1918"},"modified":"2024-04-10T16:18:02","modified_gmt":"2024-04-10T14:18:02","slug":"42b-liecivo-emicizumab-hemlibra-pri-profylaxii-krvacania-u-pacientov-vo-vsetkych-vekovych-skupinach-s-tazkou-hemofiliou-a-bez-inhibitora-faktora-viii","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/42b-liecivo-emicizumab-hemlibra-pri-profylaxii-krvacania-u-pacientov-vo-vsetkych-vekovych-skupinach-s-tazkou-hemofiliou-a-bez-inhibitora-faktora-viii\/","title":{"rendered":"42B: Lie\u010divo emicizumab (Hemlibra) pri profylaxii krv\u00e1cania u pacientov vo v\u0161etk\u00fdch vekov\u00fdch skupin\u00e1ch s \u0165a\u017ekou hemof\u00edliou A bez inhib\u00edtora 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 A (HA) je vroden\u00e9 ochorenie, prejavuj\u00face sa poruchami zr\u00e1\u017eanlivosti krvi a krv\u00e1can\u00edm, v d\u00f4sledku nedostatku faktora zr\u00e1\u017eania VIIII (FVIII). Viac ako polovica pacientov m\u00e1 \u0165a\u017ek\u00fa formu ochorenia s \u010dast\u00fdm spont\u00e1nnym krv\u00e1can\u00edm. Ochorenie ma negat\u00edvny dopad na kvalitu \u017eivota, pri krv\u00e1can\u00ed predstavuje riziko ohrozenia \u017eivota. Opakovan\u00e9 krv\u00e1canie do k\u013abov vedie k ich po\u0161kodeniu. Lie\u010dba v s\u00fa\u010dasnosti spo\u010d\u00edva v nahraden\u00ed ch\u00fdbaj\u00facich faktorov zr\u00e1\u017eania. Prepar\u00e1ty s obsahom koncentr\u00e1tov FVIII je potrebn\u00e9 aplikova\u0165 intraven\u00f3zne, pri profylaktickej lie\u010dbe \u010dasto nieko\u013ekokr\u00e1t t\u00fd\u017edenne, \u010do m\u00f4\u017ee by\u0165 u pacientov s obmedzen\u00fdm \u017eilov\u00fdm pr\u00edstupom problematick\u00e9. S aplik\u00e1ciou FVIII sa sp\u00e1ja aj riziko rozvoja inhib\u00edtorov FVIII, ktor\u00e9 ved\u00fa k zn\u00ed\u017eenej \u00fa\u010dinnosti pod\u00e1vanej faktorovej lie\u010dby. <\/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 participuj\u00faci na tomto hodnoten\u00ed uviedol, \u017ee lie\u010dba pacientov s HA je celo\u017eivotn\u00e1, u pacientov s po\u0161koden\u00edm pohybov\u00e9ho apar\u00e1tu je \u010dasto potrebn\u00e1 n\u00e1kladn\u00e1 ortopedick\u00e1 opera\u010dn\u00e1 lie\u010dba a rehabilit\u00e1cia. Emicizumab pod\u013ea neho predstavuje progres\u00edvnu, inovat\u00edvnu a bezpe\u010dn\u00fa lie\u010dbu, ktor\u00e1 umo\u017e\u0148uje \u00fa\u010dinn\u00fa profylaxiu u pacientov s inhib\u00edtormi aj bez inhib\u00edtorov. Odborn\u00edci vidia pr\u00ednos v zn\u00ed\u017een\u00ed krv\u00e1can\u00ed aj sp\u00f4sobe aplik\u00e1cie lieku Hemlibra. <\/p>\n\n\n\n

        Slovensk\u00e9 hemofilick\u00e9 zdru\u017eenie predpoklad\u00e1 obrovsk\u00fd pr\u00ednos hodnoten\u00e9ho lie\u010diva pacientov aj pre pr\u00edbuzn\u00fdch, najm\u00e4 pre rodi\u010dov najmen\u0161\u00edch det\u00ed.<\/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 \u0165a\u017ekou hemof\u00edliou A bez inhib\u00edtora faktora VIII.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Hemlibra v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala z\u00e1konn\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Hemlibra v predmetnej indik\u00e1ci\u00ed, pokia\u013e…<\/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-1918","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-emicizumab","tag-hemlibra"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1918","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1918"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1918\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1828"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1918"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1918"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1918"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}