{"id":2074,"date":"2019-11-04T20:02:51","date_gmt":"2019-11-04T19:02:51","guid":{"rendered":"http:\/\/slanedeti.sk\/cms\/?p=2074"},"modified":"2019-11-04T20:18:46","modified_gmt":"2019-11-04T19:18:46","slug":"novy-liek-na-cysticku-fibrozu-pre-90-pacientov","status":"publish","type":"post","link":"https:\/\/slanedeti.sk\/cms\/novy-liek-na-cysticku-fibrozu-pre-90-pacientov\/2074","title":{"rendered":"Nov\u00fd liek na cystick\u00fa fibr\u00f3zu pre 90% pacientov"},"content":{"rendered":"\n<p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Od schv\u00e1lenia <strong>Kalydeca<\/strong> (ivakaftoru), prv\u00e9ho\nkauz\u00e1lneho lieku na cystick\u00fa fibr\u00f3zu u\u017e uplynulo takmer 8 rokov. V\u00fdvoj\npotvrdil, \u017ee pr\u00edstup k lie\u010dbe cystickej fibr\u00f3zy ovplyvnen\u00edm funkcie CFTR\nprote\u00ednu je spr\u00e1vny a viedol k objaveniu viacer\u00fdch nov\u00fdch molek\u00fal, ktor\u00e9 boli\nozna\u010den\u00e9 ako CFTR modul\u00e1tory. N\u00e1stup CFTR modul\u00e1torov je najd\u00f4le\u017eitej\u0161\u00edm\ns\u00fa\u010dasn\u00fdm pokrokom a <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S156919931830585X\">trendom<\/a> v lie\u010dbe cystickej fibr\u00f3zy. Tie\u017e z v\u00fdsledkov\nv\u00fdskumu vyplynulo, \u017ee \u00fa\u010dinnos\u0165 t\u00fdchto liekov je vy\u0161\u0161ia, ke\u010f sa pou\u017e\u00edvaj\u00fa v\nkombin\u00e1cii. \u010eal\u0161\u00edm liekom bol v roku 2015 <strong>Orkambi<\/strong> (kombin\u00e1cia\nlumakaftoru a ivakaftoru). <\/p>\n\n\n\n<p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Nasledoval <strong>Symdeko\/<\/strong><strong><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/overview\/symkevi-epar-medicine-overview_sk.pdf\">Symkevi<\/a><\/strong>, ktor\u00fd je kombin\u00e1ciou tezakaftoru a ivakaftoru.\nJe ur\u010den\u00fd pre pacientov, ktor\u00ed maj\u00fa dve mut\u00e1cie F508del, alebo jednu mut\u00e1ciu\nF508del a niektor\u00fa \u010fal\u0161iu mut\u00e1ciu, na ktor\u00fa tento liek \u00fa\u010dinkuje (14 menej\n\u010dast\u00fdch mut\u00e1cii). Bol uveden\u00fd na trh v roku 2018. Obchodn\u00fd n\u00e1zov Symdeko sa\npou\u017e\u00edva v USA, v EU je zaregistrovan\u00fd ako <strong>Symkevi<\/strong>.<\/p>\n\n\n\n<p>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Najnov\u0161\u00edm liekom je <strong>Trikafta<\/strong>, ktor\u00e1 z\u00edskala schv\u00e1lenie americkej FDA 21. okt\u00f3bra 2019 (e\u0161te nem\u00e1 schv\u00e1lenie Eur\u00f3pskej liekovej agent\u00fary pre uvedenie na trh v EU, Vertex u\u017e podal \u017eiados\u0165).\u00a0 Trikafta je trojkombin\u00e1ciou troch r\u00f4znych CFTR modul\u00e1torov &#8211; tezakaftoru, ivakaftoru a elexakaftoru. Je ur\u010den\u00e1 pre pacientov s\u00a0cystickou fibr\u00f3zou vo veku nad 12 rokov, ktor\u00ed maj\u00fa aspo\u0148 jednu mut\u00e1ciu F508del, bez oh\u013eadu na to, ak\u00e1 je druh\u00e1 mut\u00e1cia. Znamen\u00e1 to, \u017ee tento liek pokr\u00fdva pribli\u017ene 90\u00a0% pacientskej popul\u00e1cie, \u010do je ve\u013ek\u00fd pokrok oproti predch\u00e1dzaj\u00facim liekom zo skupiny CFTR\u00a0 modul\u00e1torov. <strong>Trikafta<\/strong> m\u00e1 tie\u017e e\u0161te priaznivej\u0161ie v\u00fdsledky klinick\u00fdch \u0161t\u00fadii v porovnan\u00ed s in\u00fdmi CFTR modul\u00e1tormi, ako zlep\u0161enie p\u013e\u00facnych funkcii o 10\u00a0% v porovnan\u00ed so Symdekom a o 14\u00a0% s placebom.<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img loading=\"lazy\" decoding=\"async\" width=\"450\" height=\"450\" src=\"https:\/\/slanedeti.sk\/cms\/wp-content\/uploads\/2019\/11\/trikafta.jpg\" alt=\"\" class=\"wp-image-2079\" srcset=\"https:\/\/slanedeti.sk\/cms\/wp-content\/uploads\/2019\/11\/trikafta.jpg 450w, https:\/\/slanedeti.sk\/cms\/wp-content\/uploads\/2019\/11\/trikafta-150x150.jpg 150w, https:\/\/slanedeti.sk\/cms\/wp-content\/uploads\/2019\/11\/trikafta-300x300.jpg 300w\" sizes=\"auto, (max-width: 450px) 100vw, 450px\" \/><\/figure><\/div>\n\n\n\n<p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; V\u0161etky CFTR modul\u00e1tory, ktor\u00e9 sa v s\u00fa\u010dasnosti pou\u017e\u00edvaj\u00fa v\nklinickej praxi, vyvinula farmaceutick\u00e1 spolo\u010dnos\u0165 Vertex. D\u00f4le\u017eit\u00e9 ale je, \u017ee\nv\u00fdskumom v tejto farmakologickej skupine sa venuj\u00fa aj \u010fal\u0161ie farmaceutick\u00e9\nfirmy, pri\u010dom viacero liekov je u\u017e v r\u00f4znych \u0161t\u00e1di\u00e1ch klinick\u00e9ho sk\u00fa\u0161ania.\nPreh\u013ead n\u00e1jdete v tejto <a href=\"http:\/\/klubcf.sk\/wp-content\/uploads\/2018\/01\/PREHLAD-VYSKUMU-OPRAVA-CFRT-PROTEINU.pdf\">tabu\u013eke<\/a>.&nbsp; <\/p>\n\n\n\n<p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Najv\u00e4\u010d\u0161\u00edm probl\u00e9mom v pr\u00edstupe pacientov k lie\u010dbe CFTR\nmodul\u00e1tormi bola od za\u010diatku ich extr\u00e9mne vysok\u00e1 cena. Postupom \u010dasu Vertex\nuzavrel vo viacer\u00fdch eur\u00f3pskych krajin\u00e1ch dohody o pr\u00edstupe k liekom. Tieto\nrokovania (so zdravotn\u00fdmi pois\u0165ov\u0148ami, resp. in\u00fdmi kompetentn\u00fdmi \u00faradmi v\ndan\u00fdch krajin\u00e1ch) boli spravidla zd\u013ahav\u00e9 a ich v\u00fdsledky \u010dasto nie s\u00fa plne\nzverejnen\u00e9, resp. nie je zverejnen\u00e1 cena, za ktor\u00fa bude dan\u00e1 krajina lieky\nnakupova\u0165. Najnov\u0161ie ohl\u00e1sil Vertex tak\u00fato dohodu napr\u00edklad s NHS England, \u010do\numo\u017en\u00ed 5000 pacientom s cystickou fibr\u00f3zou v Anglicku pr\u00edstup k lie\u010dbe CFTR\nmodul\u00e1tormi hradenej z verejn\u00e9ho zdravotn\u00e9ho poistenia. Pribli\u017ene v rovnakom\n\u010dase (21.10.2019) bola potvrden\u00e1 dohoda Vertexu so \u0160panielskou vl\u00e1dou. V\ns\u00fa\u010dasnosti s\u00fa CFTR modul\u00e1tory hraden\u00e9 pacientom zo zdrojov zdravotn\u00e9ho\npoistenia v 17 krajin\u00e1ch, okrem in\u00fdch v Austr\u00e1lii, Rak\u00fasku, D\u00e1nsku, Nemecku,\n\u00cdrsku, Taliansku, Holandsku, \u0160v\u00e9dsku, USA. Ro\u010dn\u00e1 cena lie\u010dby liekom Orkambi na\njedn\u00e9ho pacienta je v USA 259&nbsp;000 dol\u00e1rov. Pri rokovaniach pon\u00fakol Vertex v Eur\u00f3pe\n\u010diasto\u010dn\u00e9 \u00fa\u013eavy. Je napr\u00edklad zn\u00e1me, \u017ee v Holandsku bola najprv dohodnut\u00e1 cena\n175&nbsp;000 eur\/rok, t\u00e1to dohoda v\u0161ak bola n\u00e1sledne Holandskom zamietnut\u00e1 a\nn\u00e1sledne op\u00e4\u0165 znovu vyrokovan\u00e1 na cenu, ktor\u00e1 ostala utajen\u00e1. Nov\u00fd liek m\u00e1 po\nuveden\u00ed na trh tzv. ochrann\u00fa dobu, po\u010das ktorej nem\u00f4\u017ee in\u00fd v\u00fdrobca pon\u00faka\u0165 liek\ns rovnakou \u00fa\u010dinnou l\u00e1tkou (generikum), pri\u010dom d\u013a\u017eka tejto doby je pribli\u017ene 10\nrokov (l\u00ed\u0161i sa v ka\u017edej krajine). Znamen\u00e1 to, \u017ee po roku 2022 m\u00f4\u017eu postupne na\ntrh prich\u00e1dza\u0165 generik\u00e1 s ni\u017e\u0161ou cenou. Nie v\u0161etky krajiny v\u0161ak uzn\u00e1vaj\u00fa\npravidl\u00e1 10-ro\u010dnej ochrannej doby a u\u017e v s\u00fa\u010dasnosti vyr\u00e1ba argent\u00ednska\nfarmaceutick\u00e1 firma Gador generick\u00fd liek <a href=\"https:\/\/www.theguardian.com\/society\/2019\/jun\/04\/families-create-buyers-club-for-cut-price-cystic-fibrosis-drug\">Lucaftor,<\/a> ktor\u00fd m\u00e1 zodpoveda\u0165 Orkambi, pri\u010dom jeho cena je\nni\u017eia pribli\u017ene o 80&nbsp;%. Taktie\u017e, ako je uveden\u00e9 vy\u0161\u0161ie, CFTR modul\u00e1tory\n(nie generik\u00e1, ale molekuly podobnej \u0161trukt\u00fary) vyv\u00edjaj\u00fa aj \u010fal\u0161ie\nfarmaceutick\u00e9 firmy, ktor\u00e9 ak sa im podar\u00ed uvies\u0165 ich lieky na trh, bud\u00fa za\nnieko\u013eko rokov konkurova\u0165 Vertexu.<\/p>\n\n\n\n<p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ako vidie\u0165, veci vo svete sa postupne h\u00fdbu vpred, mnoh\u00ed\nsi zrejme klad\u00fa ot\u00e1zku, ak\u00e1 je v tomto smere situ\u00e1cia na Slovensku. Pozit\u00edvna\nspr\u00e1va je, \u017ee Vertex podal v okt\u00f3bri 2019 \u017eiados\u0165 o zaradenie Orkambi do\nkategoriz\u00e1cie, teda umo\u017enenie \u00fahrady zo zdravotn\u00e9ho poistenia. \u017diados\u0165\nsamozrejme podlieha schv\u00e1leniu kategoriza\u010dnej komisie ministerstva\nzdravotn\u00edctva. Slovensk\u00e1 CF komunita plne podporuje pr\u00e1vo pacientov na pr\u00edstup\nk inovat\u00edvnej lie\u010dbe a aj za t\u00fdmto \u00fa\u010delom jej predstavitelia zorganizovali\nviacero informa\u010dn\u00fdch a podporn\u00fdch akcii.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">S\u00favisiace \u010dl\u00e1nky <\/h4>\n\n\n\n<figure class=\"wp-block-embed-wordpress wp-block-embed is-type-wp-embed is-provider-slane-deti\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"GgLFtffSla\"><a href=\"https:\/\/slanedeti.sk\/cms\/kalydeco-a-orkambi-prichadzaju-do-europy\/1853\">Kalydeco a Orkambi prich\u00e1dzaj\u00fa do Eur\u00f3py<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&#8220;Kalydeco a Orkambi prich\u00e1dzaj\u00fa do Eur\u00f3py&#8221; &#8212; Slan\u00e9 deti\" src=\"https:\/\/slanedeti.sk\/cms\/kalydeco-a-orkambi-prichadzaju-do-europy\/1853\/embed#?secret=PAMzp3c77a#?secret=GgLFtffSla\" data-secret=\"GgLFtffSla\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<figure class=\"wp-block-embed-wordpress wp-block-embed is-type-wp-embed is-provider-slane-deti\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"FgeAMS0aEY\"><a href=\"https:\/\/slanedeti.sk\/cms\/prelom-v-liecbe-f508del\/1710\">Prelom v lie\u010dbe f508del<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&#8220;Prelom v lie\u010dbe f508del&#8221; &#8212; Slan\u00e9 deti\" src=\"https:\/\/slanedeti.sk\/cms\/prelom-v-liecbe-f508del\/1710\/embed#?secret=QOPvWFy9E1#?secret=FgeAMS0aEY\" data-secret=\"FgeAMS0aEY\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<figure class=\"wp-block-embed-wordpress wp-block-embed is-type-wp-embed is-provider-slane-deti\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"M2cz4dxPtD\"><a href=\"https:\/\/slanedeti.sk\/cms\/36-europska-cf-konferencia-3-cast-vyvoj-novych-liekov-2\/930\">36. Eur\u00f3pska CF konferencia &#8211; 3. \u010das\u0165: V\u00fdvoj nov\u00fdch liekov<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&#8220;36. Eur\u00f3pska CF konferencia &#8211; 3. \u010das\u0165: V\u00fdvoj nov\u00fdch liekov&#8221; &#8212; Slan\u00e9 deti\" src=\"https:\/\/slanedeti.sk\/cms\/36-europska-cf-konferencia-3-cast-vyvoj-novych-liekov-2\/930\/embed#?secret=QW0bMAYV89#?secret=M2cz4dxPtD\" data-secret=\"M2cz4dxPtD\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<figure class=\"wp-block-embed-wordpress wp-block-embed is-type-wp-embed is-provider-slane-deti\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"3wcZHdRayA\"><a href=\"https:\/\/slanedeti.sk\/cms\/liek-na-vylepsenie-mutacie-g551d-pri-cystickej-fibroze\/879\">Liek na vylep\u0161enie mut\u00e1cie G551D pri cystickej fibr\u00f3ze<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&#8220;Liek na vylep\u0161enie mut\u00e1cie G551D pri cystickej fibr\u00f3ze&#8221; &#8212; Slan\u00e9 deti\" src=\"https:\/\/slanedeti.sk\/cms\/liek-na-vylepsenie-mutacie-g551d-pri-cystickej-fibroze\/879\/embed#?secret=BX9MbWrpSL#?secret=3wcZHdRayA\" data-secret=\"3wcZHdRayA\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Od schv&aacute;lenia Kalydeca (ivakaftoru), prv&eacute;ho kauz&aacute;lneho lieku na cystick&uacute; fibr&oacute;zu u&#382; uplynulo takmer 8 rokov. V&yacute;voj potvrdil, &#382;e pr&iacute;stup k lie&#269;be cystickej fibr&oacute;zy ovplyvnen&iacute;m funkcie CFTR prote&iacute;nu je spr&aacute;vny a viedol k objaveniu viacer&yacute;ch nov&yacute;ch molek&uacute;l, ktor&eacute; boli ozna&#269;en&eacute; &hellip; <a href=\"https:\/\/slanedeti.sk\/cms\/novy-liek-na-cysticku-fibrozu-pre-90-pacientov\/2074\">Continued<\/a><\/p>\n","protected":false},"author":7,"featured_media":2080,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"kt_blocks_editor_width":"","footnotes":""},"categories":[3],"tags":[],"class_list":["post-2074","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lieky-a-liecba"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nov\u00fd liek na cystick\u00fa fibr\u00f3zu pre 90% pacientov - Slan\u00e9 deti<\/title>\n<meta name=\"description\" content=\"Trikafta je trojkombin\u00e1ciou troch r\u00f4znych CFTR modul\u00e1torov a pokr\u00fdva 90% pacientov. Je ur\u010den\u00e1 pre pacientov s cystickou fibr\u00f3zou, ktor\u00ed maj\u00fa jednu mut\u00e1ciu F508del a druh\u00fa \u013eubovo\u013en\u00fa.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/slanedeti.sk\/cms\/novy-liek-na-cysticku-fibrozu-pre-90-pacientov\/2074\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nov\u00fd liek na cystick\u00fa fibr\u00f3zu pre 90% pacientov - Slan\u00e9 deti\" \/>\n<meta property=\"og:description\" content=\"Trikafta je trojkombin\u00e1ciou troch r\u00f4znych CFTR modul\u00e1torov a pokr\u00fdva 90% pacientov. 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