{"id":3192,"date":"2016-07-19T11:56:10","date_gmt":"2016-07-19T14:56:10","guid":{"rendered":"https:\/\/prodoctor.net\/blog\/?p=3192"},"modified":"2019-02-05T15:17:59","modified_gmt":"2019-02-05T18:17:59","slug":"industria-nacional-desenvolve-generico-para-prevencao-do-hiv","status":"publish","type":"post","link":"https:\/\/prodoctor.net\/blog\/industria-nacional-desenvolve-generico-para-prevencao-do-hiv\/","title":{"rendered":"Ind\u00fastria nacional desenvolve gen\u00e9rico para preven\u00e7\u00e3o do HIV"},"content":{"rendered":"<p>O Brasil caminha para ter o <strong>primeiro gen\u00e9rico do medicamento<\/strong> norte-americano Truvada, que previne contamina\u00e7\u00e3o pelo v\u00edrus HIV (V\u00edrus da Imunodefici\u00eancia Humana), causador da Aids. Atualmente, <strong>o produto \u00e9 importado pelos brasileiros<\/strong> a um custo elevado e o Minist\u00e9rio da Sa\u00fade (MS) tamb\u00e9m <strong>importa componentes do rem\u00e9dio<\/strong> para distribui\u00e7\u00e3o pelo Sistema \u00danico de Sa\u00fade (SUS).<\/p>\n<p>Na Europa e nos Estados Unidos, <strong>o medicamento custa 400 euros<\/strong>, podendo chegar a US$ 1 mil. A fabrica\u00e7\u00e3o do gen\u00e9rico no Brasil, com o registro da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa), <strong>pode reduzir esse valor para um custo mensal<\/strong> de US$ 100 ou cerca de R$ 350 mensais. Segundo a Assessoria de Imprensa do MS, o <strong>gen\u00e9rico foi desenvolvido pela empresa brasileira Blanver<\/strong>, integrante do grupo de <strong>ind\u00fastrias farmac\u00eauticas<\/strong> que firmaram Parcerias para o Desenvolvimento Produtivo com o MS.<\/p>\n<p>As PDPs foram criadas pelo Minist\u00e9rio da Sa\u00fade <strong>para fortalecer a ind\u00fastria nacional farmoqu\u00edmica<\/strong> e de medicamentos atrav\u00e9s da Portaria n\u00ba 837\/2012. Conforme sua filosofia, a ind\u00fastria <strong>desenvolve a tecnologia de medicamentos<\/strong> e tem o <strong>prazo de cinco anos<\/strong> para transferir essa tecnologia para a Funda\u00e7\u00e3o Instituto Oswaldo Cruz (Fiocruz). Ap\u00f3s esses cinco anos, <strong>a Fiocruz domina o processo<\/strong> e passa a fornecer diretamente para o Minist\u00e9rio.<\/p>\n<h4>Efic\u00e1cia equivalente<\/h4>\n<p>A droga surge como nova op\u00e7\u00e3o e j\u00e1 <strong>passou por testes comprovando efic\u00e1cia<\/strong> equivalente ao Truvada e espera-se que<strong> at\u00e9 o fim do ano esteja liberado para comercializa\u00e7\u00e3o<\/strong>.\u00a0Sua <strong>grande vantagem \u00e9 o pre\u00e7o<\/strong> e a expectativa \u00e9 a de que seja <strong>50% mais barato<\/strong> do que o Truvada, j\u00e1 se discutindo se a droga ser\u00e1 incorporada no sistema p\u00fablico e como isso ocorrer\u00e1. Parte do medicamento gen\u00e9rico <strong>dever\u00e1 ser distribu\u00edda pelo SUS<\/strong> e<strong> parte ser\u00e1 destinada a pacientes fora do SUS<\/strong>.<\/p>\n<p>Segundo o Minist\u00e9rio da Sa\u00fade, ainda n\u00e3o h\u00e1 pedido de incorpora\u00e7\u00e3o do medicamento gen\u00e9rico do Truvada no \u00f3rg\u00e3o e a <strong>Anvisa aguarda a entrada do pedido de autoriza\u00e7\u00e3o<\/strong> da ind\u00fastria farmac\u00eautica para avalia\u00e7\u00e3o. A expectativa \u00e9 que a Ag\u00eancia <strong>defina o registro ao gen\u00e9rico<\/strong> em menos de um ano. O novo medicamento n\u00e3o tem como objetivo substituir os m\u00e9todos de preven\u00e7\u00e3o j\u00e1 estabelecidos, mas sim se<strong> tornar mais uma alternativa aos m\u00e9todos existentes<\/strong>, como a camisinha masculina e feminina e os testes de Doen\u00e7as Sexualmente Transmiss\u00edveis (DSTs).<\/p>\n<h4>Dossi\u00ea<\/h4>\n<p>O dossi\u00ea sobre o Truvada est\u00e1 sendo finalizado e, em breve a Blanver entrar\u00e1 com o pedido de seu registro na Anvisa. Conforme revelou \u00e0 Ag\u00eancia Brasil o presidente-executivo (CEO) da empresa, S\u00e9rgio Frangioni, o <strong>medicamento \u00e9 composto por dois princ\u00edpios ativos<\/strong>: Entricitabina e Tenofovir. Todas as etapas do processo de desenvolvimento da droga j\u00e1 foram cumpridas, incluindo a formula\u00e7\u00e3o, iniciada em 2012, a estabilidade do produto e a fase de bioequival\u00eancia, quando o gen\u00e9rico \u00e9 comparado com o produto de refer\u00eancia e<strong> tem sua efic\u00e1cia comprovada<\/strong>.<\/p>\n<p>A pessoa que o tomar todos os dias <strong>corre um risco muito menor<\/strong> de ser infectado por algu\u00e9m com o v\u00edrus durante uma rela\u00e7\u00e3o sexual, por exemplo. Frangioni ressaltou que o Truvada n\u00e3o tem disponibilidade no mercado nacional, <strong>o que justifica sua atual importa\u00e7\u00e3o<\/strong>. E acrescentou que a preven\u00e7\u00e3o \u201c\u00e9 para indiv\u00edduo que n\u00e3o foi exposto\u201d, afirmando que \u201co Minist\u00e9rio da Sa\u00fade <strong>fornece os medicamentos para tratamento<\/strong>, n\u00e3o para preven\u00e7\u00e3o pr\u00e9-exposi\u00e7\u00e3o. Ele s\u00f3 fornece para preven\u00e7\u00e3o p\u00f3s-exposi\u00e7\u00e3o\u201d, sendo o antirretroviral Tenofovir para pessoas com o HIV.<\/p>\n<h4>Foco no grupo de risco<\/h4>\n<p>O gen\u00e9rico do Truvada <strong>tem como foco as pessoas que comp\u00f5em o grupo de risco<\/strong>, al\u00e9m de profissionais do sexo, a fim de evitar o crescimento do n\u00famero de indiv\u00edduos que precisar\u00e3o de tratamento pelo resto da vida.<\/p>\n<p>\u201c\u00c9 <strong>melhor voc\u00ea prevenir pontualmente<\/strong> do que contrair o v\u00edrus e ter de <strong>tomar rem\u00e9dio pelo resto da vida<\/strong>. Isso se demonstrou bastante eficaz porque, infelizmente, hoje tem muita gente que <strong>n\u00e3o faz sexo seguro<\/strong> e imagina que o tratamento resolver\u00e1. A pessoa <strong>prefere o risco de pegar a doen\u00e7a<\/strong>, sabendo que tem um tratamento, mas n\u00e3o sabe as consequ\u00eancias no longo prazo. <strong>A ideia \u00e9 dar essa ferramenta a mais<\/strong> para os desavisados se conscientizarem\u201d, alertou o presidente-executivo da Blanver.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>O Brasil caminha para ter o primeiro gen\u00e9rico do medicamento norte-americano Truvada, que previne contamina\u00e7\u00e3o pelo v\u00edrus HIV (V\u00edrus&#8230;<\/p>\n","protected":false},"author":1,"featured_media":3194,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kadence_starter_templates_imported_post":false,"_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"footnotes":""},"categories":[415],"tags":[],"class_list":["post-3192","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicamentos-e-farmacia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ind\u00fastria nacional desenvolve gen\u00e9rico 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