{"id":1940,"date":"2023-11-16T16:50:00","date_gmt":"2023-11-16T15:50:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1940"},"modified":"2024-04-10T16:55:02","modified_gmt":"2024-04-10T14:55:02","slug":"49-liecivo-maribavir-livtencity-na-liecbu-refrakternej-cytomegalovirusovej-cmv-infekcie-a-alebo-choroby-po-transplantacii-hematopoetickych-kmenovych-buniek-alebo-solidnych-organov","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/49-liecivo-maribavir-livtencity-na-liecbu-refrakternej-cytomegalovirusovej-cmv-infekcie-a-alebo-choroby-po-transplantacii-hematopoetickych-kmenovych-buniek-alebo-solidnych-organov\/","title":{"rendered":"49: Lie\u010divo maribavir (Livtencity) na lie\u010dbu refrakt\u00e9rnej cytomegalov\u00edrusovej (CMV) infekcie a\/alebo choroby po transplant\u00e1cii hematopoetick\u00fdch kme\u0148ov\u00fdch buniek alebo sol\u00eddnych org\u00e1nov"},"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

    CMV je v\u00edrus be\u017ene sa vyskytuj\u00faci v zdravej popul\u00e1cii. U zdrav\u00e9ho \u010dloveka m\u00e1 prim\u00e1rna infekcia mierny priebeh, po prim\u00e1rnej infekcii CMV zost\u00e1va v tele \u010dloveka v latentnej forme. Jeho reaktiv\u00e1cia nast\u00e1va v pr\u00edpade oslaben\u00e9ho imunitn\u00e9ho syst\u00e9mu. Odhaduje sa, \u017ee CMV m\u00e1 v tele 70 % popul\u00e1cie. Rizikovou skupinou, z poh\u013eadu z\u00e1va\u017en\u00e9ho priebehu CMV infekcie, s\u00fa pacienti po transplant\u00e1cii sol\u00eddnych org\u00e1nov a krvotvorn\u00fdch buniek u\u017e\u00edvaj\u00faci imunosupres\u00edvnu lie\u010dbu. Pacienti trpiaci CMV chorobou m\u00f4\u017eu poci\u0165ova\u0165 \u0161irok\u00e9 spektrum prejavov, ak\u00fdmi s\u00fa \u00fanava, hor\u00fa\u010dka, nauzea, hna\u010dka, rozmazan\u00e9 videnie a in\u00e9. Hlavnou v\u00fdzvou v lie\u010dbe CMV infekcie\/choroby je refrakt\u00e9rna forma CMV, neodpovedaj\u00faca na lie\u010dbu be\u017ene pou\u017e\u00edvan\u00fdmi antivirotikami, ktor\u00e1 m\u00f4\u017ee vy\u00fasti\u0165 a\u017e do hospitaliz\u00e1cie pacienta. Refrakt\u00e9rna forma CMV infekcie m\u00e1 nezanedbate\u013en\u00fd vplyv na zotavenie pacienta po transplant\u00e1cii a zhor\u0161uje in\u00e9 komorbidity pacienta. <\/p>\n\n\n\n

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

      Maribavir je kompetit\u00edvny inhib\u00edtor prote\u00ednkin\u00e1zy pUL97, ktor\u00e1 m\u00e1 d\u00f4le\u017eit\u00fa funkciu v nieko\u013ek\u00fdch f\u00e1zach \u017eivotn\u00e9ho cyklu CMV. M\u00e1 nar\u00fa\u0161a\u0165 replik\u00e1ciu, matur\u00e1ciu, enkapsid\u00e1ciu a aj uvo\u013enenie CMV DNA z jadra napadnutej bunky.<\/p>\n\n\n\n

      Liek Livtencity je registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou od novembra 2022.<\/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\u00edci o\u010dak\u00e1vaj\u00fa v\u00fdznamn\u00fd klinick\u00fd pr\u00ednos lieku Livtencity, nako\u013eko v s\u00fa\u010dasnosti na Slovensku nie je kategorizovan\u00fd liek na lie\u010dbu refrakt\u00e9rnej formy CMV infekcie\/choroby. Vysok\u00e9 o\u010dak\u00e1vania s\u00fa spojen\u00e9 aj s priaznivej\u0161\u00edm bezpe\u010dnostn\u00fdm profilom lieku Livtencity v porovnan\u00ed s dostupnou antivirotickou lie\u010dbou.<\/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 (Takeda Pharmaceuticals International AG Ireland) podal \u017eiados\u0165 o zaradenie lie\u010diva maribavir (Livtencity) na lie\u010dbu refrakt\u00e9rnej cytomegalov\u00edrusovej (CMV) infekcie a\/alebo choroby po transplant\u00e1cii hematopoetick\u00fdch kme\u0148ov\u00fdch buniek alebo sol\u00eddnych org\u00e1nov.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Livtencity 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
          • uprav\u00ed indika\u010dn\u00e9 obmedzenie pod\u013ea n\u00e1vrhu NIHO<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Livtencity v predmetnej indik\u00e1ci\u00ed, pokia\u013e…<\/p>","protected":false},"author":3,"featured_media":1942,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[130,131],"class_list":["post-1940","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-livtencity","tag-maribavir"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1940","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=1940"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1940\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1942"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1940"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1940"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}