{"id":1818,"date":"2022-12-27T15:07:00","date_gmt":"2022-12-27T14:07:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1818"},"modified":"2024-03-30T15:09:49","modified_gmt":"2024-03-30T14:09:49","slug":"20-sofosbuvir-a-velpatasvir-epclusa-na-liecbu-chronickej-hepatitidy-c-u-deti-vo-veku-3-rokov-a-starsich-a-dospelych-bez-cirhozy-alebo-v-stadiu-kompenzovanej-cirhozy","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/20-sofosbuvir-a-velpatasvir-epclusa-na-liecbu-chronickej-hepatitidy-c-u-deti-vo-veku-3-rokov-a-starsich-a-dospelych-bez-cirhozy-alebo-v-stadiu-kompenzovanej-cirhozy\/","title":{"rendered":"20: Sofosbuvir a velpatasvir (Epclusa) na lie\u010dbu chronickej hepatit\u00eddy C u det\u00ed vo veku 3 rokov a star\u0161\u00edch a dospel\u00fdch bez cirh\u00f3zy alebo v \u0161t\u00e1diu kompenzovanej cirh\u00f3zy"},"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

    Chronick\u00e1 hepatit\u00edda C (CHC) je z\u00e1palov\u00e9 ochorenie pe\u010dene, ktor\u00e9 sp\u00f4sobuje infekcia v\u00edrusom hepatit\u00eddy C (HCV). Celkovo je zn\u00e1mych 6 hlavn\u00fdch genotypov HCV, na Slovensku je naj\u010dastej\u0161ie zast\u00fapen\u00fd genotyp 1 a 3. Genotyp 3 je \u010dastej\u0161ie zast\u00fapen\u00fd v popul\u00e1cii mlad\u00fdch drogovo z\u00e1visl\u00fdch. <\/p>\n\n\n\n

    Po odznen\u00ed pr\u00edznakov ak\u00fatnej infekcie, ak sa objavuj\u00fa, (hor\u00fa\u010dka, \u00fanava, mal\u00e1tnos\u0165, bolesti hlavy, v\u00fdrazn\u00e9 nechutenstvo, nauzea a zvracanie, niekedy bolesti k\u013abov, hna\u010dka i ka\u0161e\u013e, svrbenie, ikterus (\u017elta\u010dka) – tmav\u00fd mo\u010d, do \u017elta sfarben\u00e9 skl\u00e9ry a ko\u017ea, svetl\u00e1 stolica) sa po 2 – 3 t\u00fd\u017ed\u0148och pacienti c\u00edtia lep\u0161ie, ustupuje \u017elta\u010dka. <\/p>\n\n\n\n

    Chronick\u00e9 ochorenie sa rozvinie u 55 \u2013 85% pacientov s ak\u00fatnou infekciou HCV. Zv\u00e4\u010d\u0161a je asymptomatick\u00e9, pr\u00edpadne sa objavuj\u00fa ne\u0161pecifick\u00e9 pr\u00edznaky ako \u00fanava, nechutenstvo, neur\u010dit\u00e9 bolesti brucha alebo k\u013abov. Pri nelie\u010denom chronickom ochoren\u00ed m\u00f4\u017ee doch\u00e1dza\u0165 k rozvoju cirh\u00f3zy a rakoviny pe\u010dene. U oboch t\u00fdchto ochoren\u00ed je CHC celosvetovo naj\u010dastej\u0161ou pr\u00ed\u010dinou ich rozvoja. U os\u00f4b s CHC je aj v\u00e4\u010d\u0161ia pravdepodobnos\u0165 rozvoja kognit\u00edvnej dysfunkcie, \u00fanavy a depresie.<\/p>\n\n\n\n

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

      Epclusa je liek obsahuj\u00faci lie\u010div\u00e1 sofosbuvir a velpatasvir, ktor\u00e9 patria medzi priamo p\u00f4sobiace antivirotik\u00e1. Po\u010det tabliet v jednom balen\u00ed je 28.<\/p>\n\n\n\n

      Liek Epclusa bol pre dospel\u00fdch pacientov zaregistrovan\u00fd v Eur\u00f3pskej \u00fanii d\u0148a 6.7.2016 na lie\u010dbu chronickej infekcie v\u00edrusom hepatit\u00eddy C. D\u0148a 11.11.2021 Eur\u00f3pska liekov\u00e1 agent\u00fara odporu\u010dila roz\u0161\u00edrenie registr\u00e1cie pre deti vo veku od 3 rokov.<\/p>\n\n\n\n

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

        Drogovo z\u00e1visl\u00ed nesp\u013a\u0148aj\u00faci podmienku abstinencie a t\u00fdm s\u00fa vyl\u00fa\u010den\u00ed z lie\u010dby CHC z d\u00f4vodu pr\u00edtomnosti in\u00e9ho ochorenia, ich z\u00e1vislosti. Vyl\u00fa\u010denie drogovo z\u00e1visl\u00fdch z lie\u010dby CHC potvrdili odborn\u00edci z klinickej praxe aj z\u00e1stupca pacientskej organiz\u00e1cie. <\/p>\n\n\n\n

        Odstr\u00e1nenie podmienky abstinencie z indika\u010dn\u00e9ho obmedzenia je v s\u00falade s odpor\u00fa\u010daniami Eur\u00f3pskej asoci\u00e1cie pre \u0161t\u00fadium pe\u010dene, Eur\u00f3pskeho monitorovacieho centra pre drogy a drogov\u00fa z\u00e1vislos\u0165 a Svetovej zdravotn\u00edckej organiz\u00e1cie a je v s\u00falade s o\u010dak\u00e1vaniami odborn\u00edkov a pacientov.<\/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 (Gilead Sciences) po\u017eaduje roz\u0161\u00edrenie s\u00fa\u010dasne platn\u00e9ho indika\u010dn\u00e9ho obmedzenia lieku Epclusa. V navrhovanej \u00faprave \u017eiada roz\u0161\u00edri\u0165 \u00fahradu lieku pre tri nov\u00e9 skupiny pacientov:<\/p>\n\n\n\n

            \n
          1. Pacientov, ktor\u00ed boli v minulosti drogovo z\u00e1visl\u00ed a s\u00fa\u010dasne nesp\u013a\u0148aj\u00fa aktu\u00e1lnu podmienku o aspo\u0148 ro\u010dnej abstinencii a pacientov, ktor\u00ed s\u00fa aktu\u00e1lne drogovo z\u00e1visl\u00ed. NIHO odhaduje, \u017ee tak\u00fdchto pacientov je na Slovensku 1744 – 3163.<\/li>\n\n\n\n
          2. Deti vo veku 3 rokov a star\u0161ie. NIHO s\u00fahlas\u00ed s odhadom dr\u017eite\u013ea registr\u00e1cie, \u017ee po\u010det pacientov v tejto skupine je 4 – 6 ro\u010dne.<\/li>\n\n\n\n
          3. Pacienti s genotypom HCV 2, ktor\u00ed s\u00fa vhodn\u00ed na lie\u010dbu interfer\u00f3nom. NIHO s\u00fahlas\u00ed s odhadom dr\u017eite\u013ea registr\u00e1cie, \u017ee po\u010det pacientov v tejto skupine je 0 ro\u010dne.<\/li>\n<\/ol>\n\n\n\n

            NIHO odpor\u00fa\u010da vyhovie\u0165 <\/strong>\u017eiadosti o zmenu charakterist\u00edk referen\u010dnej skupiny <\/strong>J05AP55 Sofosbuvir a velpatasvir <\/strong>p.o. 400 mg\/100 mg.<\/p>\n\n\n\n

            Z d\u00f4vodu miernej neistoty v splnen\u00ed podmienok n\u00e1kladovej efekt\u00edvnosti odpor\u00fa\u010dame uzatvorenie zmluvy o podmienkach \u00fahrady lieku v zmysle \u00a7 7a z\u00e1kona 363\/2011 Z.z s dr\u017eite\u013eom registr\u00e1cie pod\u013ea n\u00e1vrhu, ktor\u00fd predlo\u017eil dr\u017eite\u013e registr\u00e1cie.<\/p>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o zmenu charakterist\u00edk referen\u010dnej skupiny J05AP55 Sofosbuvir a velpatasvir p.o. 400 mg\/100 mg…<\/p>","protected":false},"author":3,"featured_media":1819,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[74,76],"class_list":["post-1818","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-epclusa","tag-sofosbuvir"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1818","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=1818"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1818\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1819"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1818"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1818"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1818"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}