{"id":1927,"date":"2024-02-27T16:26:00","date_gmt":"2024-02-27T15:26:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1927"},"modified":"2024-04-10T16:32:53","modified_gmt":"2024-04-10T14:32:53","slug":"45-liecivo-brentuximab-vedotin-adcetris-v-kombinacii-s-doxorubicinom-vinblastinom-a-dakarbazinom-avd-na-liecbu-dospelych-pacientov-s-predtym-neliecenym-cd30-pozitivnym-hodgkinovym-lymfomom-v-sta","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/45-liecivo-brentuximab-vedotin-adcetris-v-kombinacii-s-doxorubicinom-vinblastinom-a-dakarbazinom-avd-na-liecbu-dospelych-pacientov-s-predtym-neliecenym-cd30-pozitivnym-hodgkinovym-lymfomom-v-sta\/","title":{"rendered":"45: Lie\u010divo brentuximab vedot\u00edn (Adcetris) v kombin\u00e1cii s doxorubic\u00ednom, vinblast\u00ednom a dakarbaz\u00ednom (AVD) na lie\u010dbu dospel\u00fdch pacientov s predt\u00fdm nelie\u010den\u00fdm CD30 pozit\u00edvnym Hodgkinov\u00fdm lymf\u00f3mom v \u0161t\u00e1diu IV"},"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

    Hodgkinov lymf\u00f3m je kurabiln\u00e9 n\u00e1dorov\u00e9 ochorenie lymfatick\u00fdch uzl\u00edn (LU), vyskytuj\u00face sa v mlad\u0161om veku (25 – 30 rokov) a n\u00e1sledne u \u013eud\u00ed star\u0161\u00edch ako 50 rokov. Prvou manifest\u00e1ciou Hodgkinovho lymf\u00f3mu b\u00fdva nebolestiv\u00e9 zv\u00e4\u010d\u0161enie LU. Pribli\u017ene 70 \u2013 80 % pacientov m\u00e1 zv\u00e4\u010d\u0161en\u00e9 kr\u010dn\u00e9 alebo supraklavikul\u00e1rne LU. Takmer 2\/3 pacientov maj\u00fa postihnut\u00e9 vn\u00fatrohrudn\u00e9 LU, \u010do sp\u00f4sobuje pocit tlaku za hrudnou kos\u0165ou, dr\u00e1\u017ediv\u00fd ka\u0161e\u013e, d\u00fdchavi\u010dnos\u0165, palpit\u00e1cie a boles\u0165 hrudn\u00edkovej chrbtice. Typick\u00e9 je aj no\u010dn\u00e9 potenie, hor\u00fa\u010dky nad 38\u00b0C a chudnutie, tzv. B-sympt\u00f3my. Viacer\u00e9 \u0161t\u00fadie preuk\u00e1zali, \u017ee pacienti, ktor\u00ed prekonali infekciu vyvolan\u00fa Epstein-Barrovej v\u00edrusom, maj\u00fa n\u00e1sobne vy\u0161\u0161ie riziko vzniku Hodgkinovho lymf\u00f3mu. V s\u00fa\u010dasnosti ide o najlep\u0161ie lie\u010dite\u013en\u00e9 zhubn\u00e9 ochorenie v dospelom veku, ktor\u00e9 aj napriek tomu vytv\u00e1ra ve\u013ek\u00fa z\u00e1\u0165a\u017e na pacientov po fyzickej aj psychickej str\u00e1nke. V z\u00e1vislosti od \u0161t\u00e1dia a rizikov\u00fdch faktorov sa vylie\u010di 85 \u2013 95 % pacientov. Trojro\u010dn\u00e9 pre\u017e\u00edvanie bez progresie je pre pokro\u010dil\u00fd Hodgkinov lymf\u00f3m 86 % a p\u00e4\u0165ro\u010dn\u00e9 71 %. <\/p>\n\n\n\n

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

      Adcetris obsahuje lie\u010divo brentuximab vedotin, liek proti rakovine, zlo\u017een\u00fd z monoklon\u00e1lnej protil\u00e1tky naviazanej na l\u00e1tku zab\u00edjaj\u00facu rakovinov\u00e9 bunky. Monoklon\u00e1lna protil\u00e1tka doprav\u00ed t\u00fato l\u00e1tku do rakovinov\u00fdch buniek. Monoklon\u00e1lna protil\u00e1tka je prote\u00edn, ktor\u00fd rozpozn\u00e1va niektor\u00e9 rakovinov\u00e9 bunky.<\/p>\n\n\n\n

      Adcetris bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare  pre hodnoten\u00fa indik\u00e1ciu v septembri  2023.<\/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

        Klinick\u00fd odborn\u00edk A uviedol, \u017ee u pacientov v pokro\u010dilom III.- IV. \u0161t\u00e1diu novodiagnostikovan\u00e9ho klasick\u00e9ho HL (cHL) CD30+ je potreba zmeny lie\u010dby u\u017e v I. l\u00ednii terapie.<\/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 Pharma A\/S (DNK)) podal \u017eiados\u0165 o zaradenie lie\u010diva brentuximab vedot\u00edn (Adcetris) v kombin\u00e1cii s doxorubic\u00ednom, vinblast\u00ednom a dakarbaz\u00ednom (AVD) na lie\u010dbu dospel\u00fdch pacientov s predt\u00fdm nelie\u010den\u00fdm CD30 pozit\u00edvnym Hodgkinov\u00fdm lymf\u00f3mom v \u0161t\u00e1diu IV.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Adcetris v predmetnej indik\u00e1ci\u00ed, nako\u013eko po\u017eadovan\u00e1 v\u00fd\u0161ka \u00fahrady sp\u013a\u0148a krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          V\u00fdsledok je spojen\u00fd so strednou mierou neistoty, \u017ee pri po\u017eadovanej \u00fahrade nebud\u00fa v praxi splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. Preto NIHO odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>\n\n\n\n

          Z\u00e1rove\u0148 NIHO odpor\u00fa\u010da doplnenie indika\u010dn\u00e9ho obmedzenia o dobr\u00fd v\u00fdkonnostn\u00fd stav pacienta.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Adcetris v predmetnej indik\u00e1ci\u00ed, nako\u013eko…<\/p>","protected":false},"author":3,"featured_media":1928,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[122,121],"class_list":["post-1927","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-adcetris","tag-brentuximab-vedotin"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1927","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=1927"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1927\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1928"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1927"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1927"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1927"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}