{"id":1835,"date":"2023-03-03T16:13:00","date_gmt":"2023-03-03T15:13:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1835"},"modified":"2024-03-30T16:36:04","modified_gmt":"2024-03-30T15:36:04","slug":"24-lieciva-tixagevimab-a-cilgavimab-evusheld-na-preexpozicnu-profylaxiu-ochorenia-covid-19","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/24-lieciva-tixagevimab-a-cilgavimab-evusheld-na-preexpozicnu-profylaxiu-ochorenia-covid-19\/","title":{"rendered":"24: Lie\u010div\u00e1 tixagevimab a cilgavimab (Evusheld) na preexpozi\u010dn\u00fa profylaxiu ochorenia COVID-19"},"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

    V marci 2020 bola vyhl\u00e1sen\u00e1 celosvetov\u00e1 pand\u00e9mia v s\u00favislosti s ochoren\u00edm COVID-19 sp\u00f4soben\u00fdm koronav\u00edrusom SARS-CoV-2. Infekcia sa pren\u00e1\u0161a najm\u00e4 kontaktom s nakazen\u00fdm, ochorenie vyvol\u00e1va v \u013eah\u0161\u00edch pr\u00edpadoch pr\u00edznaky podobn\u00e9 n\u00e1dche, v \u0165a\u017ek\u00fdch pr\u00edpadoch vedie k pneum\u00f3nii a m\u00f4\u017ee sp\u00f4sobi\u0165 smr\u0165. \u010cas\u0165 pacientov poci\u0165uje sympt\u00f3my aj viac ako 2 mesiace od n\u00e1stupu ochorenia (tzv. long-COVID). Najlep\u0161iu ochranu pred n\u00e1kazou a z\u00e1va\u017en\u00fdm priebehom ochorenia COVID-19 predstavuje o\u010dkovanie.<\/p>\n\n\n\n

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


      Evusheld je kombin\u00e1ciou dvoch \u013eudsk\u00fdch monoklon\u00e1lnych protil\u00e1tok, tixagevimab a cilgavimab, ktor\u00e9 s\u00fa upraven\u00e9 tak, aby zn\u00ed\u017eili potenci\u00e1lne riziko zosilnenia ochorenia z\u00e1visl\u00e9ho na protil\u00e1tkach. Obe protil\u00e1tky sa m\u00f4\u017eu s\u00fa\u010dasne viaza\u0165 na takzvan\u00fd \u201cspike\u201d prote\u00edn v\u00edrusu SARS-CoV-2, blokova\u0165 jeho interakciu s \u013eudsk\u00fdm receptorom ACE2, \u010do vedie k blok\u00e1de vstupu v\u00edrusu do hostite\u013eskej bunky. D\u013a\u017eka trvania ochrany po podan\u00ed jednorazovej d\u00e1vky sa odhaduje na minim\u00e1lne 6 mesiacov.<\/p>\n\n\n\n

      Evusheld bol registrovan\u00fd v EMA v 03\/2022. V USA stratil Evusheld d\u0148a 26.1.2023 registr\u00e1ciu, z d\u00f4vodu, \u017ee v\u00fdskyt variantov, ktor\u00e9 nie s\u00fa citliv\u00e9 na \u00fa\u010dinok tixagevimab a cilgavimab prekro\u010dil 90 %.<\/p>\n\n\n\n

        \n
      1. Ako sa na tixagevimab a cilgavimab pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Odborn\u00edci predpokladaj\u00fa vhodnos\u0165 lie\u010diva najm\u00e4 pre imunokompromitovan\u00fdch pacientov s prim\u00e1rnym alebo sekund\u00e1rnym imunodeficitom, ako pacienti po transplant\u00e1ci\u00e1ch sol\u00eddnych org\u00e1nov alebo kostnej drene, s hematoonkologick\u00fdm alebo onkologick\u00fdm ochoren\u00edm s aktu\u00e1lne prebiehaj\u00facou lie\u010dbou, pacienti s biologickou terapiou zameranou na B bunky, dialyzovan\u00ed, HIV pozit\u00edvni \u010di polymorb\u00eddni pacienti.<\/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 (AstraZeneca) navrhuje, aby bol liek Evusheld zaraden\u00fd do \u00fahrad z verejn\u00e9ho zdravotn\u00e9ho poistenia na preexpozi\u010dn\u00fa profylaxiu ochorenia COVID-19.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Evusheld v predmetnej indik\u00e1ci\u00ed, lebo:<\/p>\n\n\n\n

            \n
          • Testovanie lieku prebehlo v \u010dase, ke\u010f prevl\u00e1dali varianty alfa, beta, gama, delta. V\u00fdsledok testovania je spojen\u00fd s ve\u013ekou neistotou, okrem in\u00e9ho kv\u00f4li tomu, \u017ee sa nevz\u0165ahuje na aktu\u00e1lne zast\u00fapen\u00e9 varianty koronav\u00edrusu (omikron).<\/li>\n\n\n\n
          • Americk\u00fd \u00farad FDA zru\u0161il registr\u00e1ciu lieku Evusheld d\u0148a 26.1.2023.<\/li>\n\n\n\n
          • Dr\u017eite\u013e registr\u00e1cie nedodal farmako-ekonomick\u00fd model, ktor\u00fd by umo\u017enil zhodnoti\u0165 n\u00e1kladov\u00fa efekt\u00edvnos\u0165 lieku Evusheld pri pacientov, ktor\u00e9 nie s\u00fa aktu\u00e1lne infikovan\u00ed SARS-CoV-2 a ktor\u00e9 neboli ned\u00e1vno exponovan\u00ed v\u00edrusu SARS-CoV-2.<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Evusheld v predmetnej indik\u00e1ci\u00ed, lebo…<\/p>","protected":false},"author":3,"featured_media":1841,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[85,84,83],"class_list":["post-1835","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-cilgavimab","tag-evusheld","tag-tixagevimab"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1835","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=1835"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1835\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1841"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1835"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1835"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1835"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}