{"id":6810,"date":"2019-04-08T10:17:43","date_gmt":"2019-04-08T03:17:43","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=6810"},"modified":"2019-05-19T22:48:49","modified_gmt":"2019-05-19T15:48:49","slug":"fda-phe-duyet-thuoc-dovato","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/fda-phe-duyet-thuoc-dovato\/","title":{"rendered":"FDA ph\u00ea duy\u1ec7t thu\u1ed1c m\u1edbi Dovato \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n HIV"},"content":{"rendered":"<h2>FDA: Ph\u00ea duy\u1ec7t thu\u1ed1c Dovato ph\u1ed1i h\u1ee3p hai th\u00e0nh ph\u1ea7n d\u00f9ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n HIV ch\u01b0a t\u1eebng s\u1eed d\u1ee5ng thu\u1ed1c kh\u00e1ng retrovirus<\/h2>\n<p><strong>FDA \u0111\u00e3 ph\u00ea duy\u1ec7t Dovato (dolutegravir v\u00e0 lamivudine)<\/strong>, l\u00e0 m\u1ed9t li\u1ec7u ph\u00e1p ho\u00e0n ch\u1ec9nh \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb HIV-1 \u1edf b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng s\u1eed d\u1ee5ng thu\u1ed1c kh\u00e1ng retrovirus v\u00e0 ch\u01b0a x\u1ea3y ra kh\u00e1ng thu\u1ed1c v\u1edbi hai th\u00e0nh ph\u1ea7n c\u1ee7a Dovato. \u0110\u00e2y l\u00e0 thu\u1ed1c \u0111\u1ea7u ti\u00ean c\u00f3 ch\u1ee9a hai th\u00e0nh ph\u1ea7n, li\u1ec1u c\u1ed1 \u0111\u1ecbnh, \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7ts\u1eed d\u1ee5ng chob\u1ec7nh nh\u00e2n nhi\u1ec5m HIV ch\u01b0a t\u1eebng \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c.<\/p>\n<p>\u201cHi\u1ec7n t\u1ea1i, ph\u00e1c \u0111\u1ed3 ti\u00eau chu\u1ea9n ch\u0103m s\u00f3c cho b\u1ec7nh nh\u00e2n l\u1ea7n \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb HIV l\u00e0 ph\u1ed1i h\u1ee3p ba thu\u1ed1c. V\u1edbi l\u1ea7n ph\u00ea duy\u1ec7t n\u00e0y, nh\u1eefng b\u1ec7nh nh\u00e2n l\u1ea7n \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb c\u00f3 th\u00eam l\u1ef1a ch\u1ecdn d\u00f9ng ch\u1ebf \u0111\u1ed9 hai thu\u1ed1c trong m\u1ed9t vi\u00ean duy nh\u1ea5t, nh\u1edd \u0111\u00f3 h\u1ea1n ch\u1ebf b\u1edbt \u0111\u1ed9c t\u00ednh v\u00e0 t\u01b0\u01a1ng t\u00e1c thu\u1ed1c t\u1eeb thu\u1ed1c th\u1ee9 ba\u201d , \u00f4ng Debra Birnkrant, MD, Gi\u00e1m \u0111\u1ed1c B\u1ed9 ph\u1eadn Thu\u1ed1c ch\u1ed1ng vi r\u00fat . \u201c Ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb lo\u1ea1i tr\u1eeb b\u1edbt thu\u1ed1c n\u00e0y c\u00f3 th\u1ec3 gi\u1ea3m thi\u1ec3u r\u1ee7i ro cho nh\u1eefng b\u1ec7nh nh\u00e2n ph\u1ea3i s\u1eed d\u1ee5ng nhi\u1ec1u lo\u1ea1i thu\u1ed1c trong th\u1eddi gian d\u00e0i\u201d .<\/p>\n<p>Kho\u1ea3ng 1.1 tri\u1ec7u ng\u01b0\u1eddi \u1edf Hoa K\u1ef3 \u0111ang s\u1ed1ng chung v\u1edbi HIV. Kho\u1ea3ng 15% trong s\u1ed1 h\u1ecd (1 trong 7) kh\u00f4ng bi\u1ebft r\u1eb1ng h\u1ecd b\u1ecb nhi\u1ec5m b\u1ec7nh. Ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb c\u00f3 hi\u1ec7u qu\u1ea3 l\u00e0 r\u1ea5t quan tr\u1ecdng trong vi\u1ec7c gi\u1ea3m l\u01b0\u1ee3ng virus trong m\u00e1u. T\u1ea3i l\u01b0\u1ee3ng virus b\u1ecb \u1ee9c ch\u1ebf \u1edf nh\u1eefng ng\u01b0\u1eddi nhi\u1ec5m HIV ng\u0103n ng\u1eeba ti\u1ebfn tri\u1ec3n b\u1ec7nh v\u00e0 gi\u00fap h\u1ecd s\u1ed1ng l\u00e2u h\u01a1n, s\u1ed1ng kh\u1ecfe h\u01a1n. Ngo\u00e0i ra, nh\u1eefng ng\u01b0\u1eddi nhi\u1ec5m HIV s\u1eed d\u1ee5ng thu\u1ed1c \u0111i\u1ec1u tr\u1ecb HIV h\u00e0ng ng\u00e0y theo quy \u0111\u1ecbnh v\u00e0 duy tr\u00ec t\u1ea3i l\u01b0\u1ee3ng virus kh\u00f4ng ph\u00e1t hi\u1ec7n \u0111\u01b0\u1ee3c th\u1ef1c s\u1ef1 kh\u00f4ng c\u00f3 nguy c\u01a1 l\u00e2y truy\u1ec1n HIV qua \u0111\u01b0\u1eddng t\u00ecnh d\u1ee5c cho b\u1ea1n t\u00ecnh \u00e2m t\u00ednh v\u1edbi HIV.<\/p>\n<p>Nh\u00e3n thu\u1ed1c Dovato bao g\u1ed3m G\u00f3c c\u1ea3nh b\u00e1o , c\u1ea3nh b\u00e1o r\u1eb1ng b\u1ec7nh nh\u00e2n b\u1ecb nhi\u1ec5m c\u1ea3 HIV v\u00e0 vi\u00eam gan B n\u00ean \u0111i\u1ec1u tr\u1ecb b\u1ed5 sung cho b\u1ec7nh <a href=\"https:\/\/www.vnras.com\/drug\/2019\/05\/viem-gan-b.html\">vi\u00eam gan B<\/a> ho\u1eb7c xem x\u00e9t m\u1ed9t ch\u1ebf \u0111\u1ed9 thu\u1ed1c kh\u00e1c. B\u1ec7nh nh\u00e2n nhi\u1ec5m c\u1ea3 HIV v\u00e0 vi\u00eam gan B s\u1eed d\u1ee5ng c\u00e1cthu\u1ed1c c\u00f3 ch\u1ee9a lamivudine, m\u1ed9t th\u00e0nh ph\u1ea7n c\u1ee7a Dovato, \u0111\u00e3 xu\u1ea5t hi\u1ec7n c\u00e1c bi\u1ebfn th\u1ec3 vi\u00eam gan B c\u00f3 kh\u1ea3 n\u0103ng kh\u00e1ng thu\u1ed1clamivudine v\u00e0 c\u00f3 th\u1ec3 g\u00e2y ra c\u00e1c bi\u1ebfn ch\u1ee9ng t\u1ea1i gan nghi\u00eam tr\u1ecdng, bao g\u1ed3m c\u1ea3 suy gan, khi h\u1ecd ng\u1eebng d\u00f9ng thu\u1ed1c c\u00f3 ch\u1ee9a lamivudine. B\u1ec7nh nh\u00e2n nhi\u1ec5m c\u1ea3 HIV v\u00e0 virus vi\u00eam gan B c\u1ea7n ng\u1eebngs\u1eed d\u1ee5ngDovato v\u00e0 \u0111\u01b0\u1ee3c theo d\u00f5i ch\u1eb7t ch\u1ebd b\u1edfi c\u00e1c c\u00e1n b\u1ed9 y t\u1ebf.<\/p>\n<p>Hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a Dovato, u\u1ed1ng m\u1ed9t vi\u00ean m\u1ed7i ng\u00e0y, \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh trong hai th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng gi\u1ed1ng h\u1ec7t nhau, ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i, c\u00f3 ki\u1ec3m so\u00e1t \u1edf 1.433 ng\u01b0\u1eddi tr\u01b0\u1edfng th\u00e0nh nhi\u1ec5m HIV kh\u00f4ng c\u00f3 ti\u1ec1n s\u1eed \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c kh\u00e1ng vi-r\u00fat tr\u01b0\u1edbc \u0111\u00f3. C\u00e1c th\u1eed nghi\u1ec7m cho th\u1ea5y m\u1ed9t ch\u1ebf \u0111\u1ed9 thu\u1ed1c c\u00f3 ch\u1ee9a dolutegravir v\u00e0 lamivudine c\u00f3 t\u00e1c d\u1ee5ng t\u01b0\u01a1ng t\u1ef1 l\u00e0m gi\u1ea3m l\u01b0\u1ee3ng HIV trong m\u00e1u so v\u1edbi m\u1ed9t ch\u1ebf \u0111\u1ed9 thu\u1ed1c kh\u00e1c, bao g\u1ed3m dolutegravir, emtricitabine v\u00e0 tenofovir. Vi\u1ec7c \u0111i\u1ec1u tr\u1ecb \u0111\u01b0\u1ee3c coi l\u00e0 th\u00e0nh c\u00f4ng n\u1ebfu b\u1ec7nh nh\u00e2n duy tr\u00ec n\u1ed3ng \u0111\u1ed9 th\u1ea5p (d\u01b0\u1edbi 50 b\u1ea3n sao \/ ml) HIV RNA trong m\u00e1u trong \u00edt nh\u1ea5t 48 tu\u1ea7n.<\/p>\n<p>C\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i ph\u1ed5 bi\u1ebfn nh\u1ea5t c\u1ee7aDovato l\u00e0 \u0111au \u0111\u1ea7u, ti\u00eau ch\u1ea3y, bu\u1ed3n n\u00f4n, m\u1ea5t ng\u1ee7 v\u00e0 m\u1ec7t m\u1ecfi. V\u00ec c\u00f3 nguy c\u01a1 d\u1ecb t\u1eadt \u1ed1ng th\u1ea7n kinh dodolutegravir, b\u1ec7nh nh\u00e2n n\u00ean tr\u00e1nh s\u1eed d\u1ee5ng Dovato trong ba th\u00e1ng \u0111\u1ea7u c\u1ee7a thai k\u1ef3. V\u00e0o th\u00e1ng 5 n\u0103m 2018, FDA \u0111\u00e3 ph\u00e1t h\u00e0nh Th\u00f4ng tin v\u1ec1 An to\u00e0n Thu\u1ed1c li\u00ean quan \u0111\u1ebfn c\u00e1c khuy\u1ebft t\u1eadt b\u1ea9m sinh \u1ed1ng th\u1ea7n kinh \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf nh\u1eefng tr\u1ebb sinh ra t\u1eeb nh\u1eefng ph\u1ee5 n\u1eef \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng dolutegravir.<\/p>\n<p>V\u00e0o th\u00e1ng 2 n\u0103m 2019, B\u1ed9 Y t\u1ebf v\u00e0 D\u1ecbch v\u1ee5 Nh\u00e2n sinh Hoa K\u1ef3 \u0111\u00e3 c\u00f4ng b\u1ed1 m\u1ed9t s\u00e1ng ki\u1ebfn \u200b\u200bm\u1edbi, Ch\u1ea5m d\u1ee9t \u0110\u1ea1i d\u1ecbch HIV: K\u1ebf ho\u1ea1ch cho Hoa K\u1ef3, m\u1ed9t c\u01a1 h\u1ed9i hi\u1ebfm c\u00f3 \u0111\u1ec3 lo\u1ea1i b\u1ecfnguy c\u01a1 l\u00e2ynhi\u1ec5m HIV m\u1edbi \u1edf Hoa K\u1ef3. S\u00e1ng ki\u1ebfn \u200b\u200bn\u00e0y s\u1ebd cung c\u1ea5p cho c\u00e1c c\u1ed9ng \u0111\u1ed3ng b\u1ecb \u1ea3nh h\u01b0\u1edfng n\u1eb7ng n\u1ec1 nh\u1ea5t b\u1edfi HIV c\u00e1c ki\u1ebfn th\u1ee9cchuy\u00ean m\u00f4n, c\u00f4ng ngh\u1ec7 v\u00e0 t\u00e0i nguy\u00ean c\u1ea7n thi\u1ebft \u0111\u1ec3 gi\u1ea3i quy\u1ebft d\u1ecbch HIV trong c\u1ed9ng \u0111\u1ed3ng c\u1ee7a h\u1ecd, t\u1eadp trung v\u00e0o c\u00e1c \u0111\u1ecba \u0111i\u1ec3m nh\u1ea5t \u0111\u1ecbnh. M\u1ee5c \u0111\u00edch l\u00e0 \u0111\u1ec3 gi\u1ea3m 75% c\u00e1c ca m\u1eafc m\u1edbi trong n\u0103m n\u0103m t\u1edbi v\u00e0 90% trong m\u01b0\u1eddi n\u0103m t\u1edbi, ng\u0103n ch\u1eb7n h\u01a1n 250.000 ca nhi\u1ec5m HIV trong t\u01b0\u01a1ng lai.<\/p>\n<p>Ngu\u1ed3n: <a href=\"https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm635526.htm\" rel=\"noopener\">https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm635526.htm<\/a><\/p>\n<p>Ng\u01b0\u1eddi t\u1ed5ng h\u1ee3p: \u0110\u1ed7 Thu Thanh &#8211; Nguy\u1ec5n Ph\u01b0\u01a1ng Th\u00fay &#8211; Trung T\u00e2m C\u1ea3nh Gi\u00e1c D\u01b0\u1ee3c Qu\u1ed1c Gia.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA: Ph\u00ea duy\u1ec7t thu\u1ed1c Dovato ph\u1ed1i h\u1ee3p hai th\u00e0nh ph\u1ea7n d\u00f9ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n HIV ch\u01b0a t\u1eebng s\u1eed d\u1ee5ng thu\u1ed1c kh\u00e1ng retrovirus FDA \u0111\u00e3 ph\u00ea duy\u1ec7t Dovato (dolutegravir v\u00e0 lamivudine), l\u00e0 m\u1ed9t li\u1ec7u ph\u00e1p ho\u00e0n ch\u1ec9nh \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb HIV-1 \u1edf b\u1ec7nh nh\u00e2n ch\u01b0a t\u1eebng s\u1eed d\u1ee5ng thu\u1ed1c kh\u00e1ng retrovirus v\u00e0 ch\u01b0a [&#8230;]\n","protected":false},"author":1,"featured_media":6811,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-6810","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/6810","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=6810"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/6810\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/6811"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=6810"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=6810"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=6810"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}