{"id":1937,"date":"2023-12-04T16:45:00","date_gmt":"2023-12-04T15:45:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1937"},"modified":"2024-04-10T16:50:02","modified_gmt":"2024-04-10T14:50:02","slug":"48-liecivo-nirmatrelvir-a-ritonavir-paxlovid-na-liecbu-dospelych-vysokorizikovych-pacientov-s-ochorenim-covid-19","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/48-liecivo-nirmatrelvir-a-ritonavir-paxlovid-na-liecbu-dospelych-vysokorizikovych-pacientov-s-ochorenim-covid-19\/","title":{"rendered":"48: Lie\u010divo nirmatrelvir a ritonavir (Paxlovid) na lie\u010dbu dospel\u00fdch vysokorizikov\u00fdch pacientov s ochoren\u00edm COVID-19"},"content":{"rendered":"
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  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

    Ochorenie COVID-19 je v\u00edrusov\u00e9 ochorenie najm\u00e4 respira\u010dn\u00e9ho syst\u00e9mu, pri\u010dom v \u0165a\u017ek\u00fdch pr\u00edpadoch vedie k pneum\u00f3nii, alebo smrti. V marci 2020 bola vyhl\u00e1sen\u00e1 v s\u00favislosti s ochoren\u00edm celosvetov\u00e1 pand\u00e9mia. K 20.11.2022 bolo celosvetovo potvrden\u00fdch u\u017e 634 mili\u00f3nov pr\u00edpadov a 6,6 mili\u00f3na \u00famrt\u00ed. Na Slovensku bolo pozit\u00edvne testovan\u00fdch 1,9-mil. os\u00f4b, pri\u010dom ochoreniu u n\u00e1s pod\u013eahlo cez 20-tis\u00edc \u013eud\u00ed. Zv\u00fd\u0161en\u00e9 riziko hospitaliz\u00e1cie a smrti viedlo u niektor\u00fdch pacientov k zmene lie\u010dob, \u017eivotn\u00e9ho \u0161t\u00fdlu a spr\u00e1vania po\u010das pand\u00e9mie COVID-19 kv\u00f4li potrebe izol\u00e1cie. Pre vysokorizikov\u00fdch pacientov m\u00f4\u017ee strach z ochorenia COVID-19 vy\u00fasti\u0165 do pokra\u010duj\u00facej potreby izol\u00e1cie. Kategoriz\u00e1cia lieku Paxlovid by viedla k dosiahnutiu be\u017enej dostupnosti lie\u010diva v r\u00e1mci indika\u010dn\u00fdch krit\u00e9ri\u00ed, ktor\u00e9 je zatia\u013e dostupn\u00e9 z n\u00e1kupu vo verejnom obstar\u00e1van\u00ed. <\/p>\n\n\n\n

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

      Paxlovid obsahuje dve lie\u010div\u00e1, PF-07321332 a ritonavir, v dvoch r\u00f4znych tablet\u00e1ch. Paxlovid je protiv\u00edrusov\u00fd liek (antivirotikum), ktor\u00fd sa pou\u017e\u00edva na lie\u010dbu dospel\u00fdch, ktor\u00fdch stav si nevy\u017eaduje podporn\u00fa lie\u010dbu kysl\u00edkom, a u ktor\u00fdch je pr\u00edtomn\u00e9 zv\u00fd\u0161en\u00e9 riziko zhor\u0161enia ochorenia COVID-19 do z\u00e1va\u017en\u00e9ho stavu.<\/p>\n\n\n\n

      Paxlovid z\u00edskal podmiene\u010dn\u00fa registr\u00e1ciu v Eur\u00f3pskej liekovej agent\u00fare v janu\u00e1ri 2022, ktor\u00fa n\u00e1sledne nahradila \u00fapln\u00e1 registr\u00e1cia vo febru\u00e1ri 2023.<\/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 (Pfizer Europe MA EEIG) podal \u017eiados\u0165 o zaradenie lie\u010diva nirmatrelvir a ritonavir (Paxlovid) na lie\u010dbu dospel\u00fdch vysokorizikov\u00fdch pacientov s ochoren\u00edm COVID-19.<\/p>\n\n\n\n

        NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Paxlovid v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie spln\u00ed nasledovn\u00e9 podmienky: <\/p>\n\n\n\n

          \n
        • uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/li>\n\n\n\n
        • adresuje extr\u00e9mne vysok\u00fa neistotu spojen\u00fa s v\u00fdsledkom n\u00e1kladovej efekt\u00edvnosti v zmluve o podmienkach \u00fahrady lieku. Neistota vypl\u00fdva z n\u00edzkej kvality d\u00f4kazu o \u00fa\u010dinnosti lieku a z nejasn\u00e9ho bud\u00faceho v\u00fdvoja epidemiologickej situ\u00e1cie.<\/li>\n<\/ul>\n\n\n\n

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

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Paxlovid v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie…<\/p>","protected":false},"author":3,"featured_media":1938,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[128,127,129],"class_list":["post-1937","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-nirmatrelvir","tag-paxlovid","tag-ritonavir"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1937","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=1937"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1937\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1938"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1937"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1937"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1937"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}