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Skip to content Um novo tratamento de influenza de dose única, desenvolvido e aprovado no Japão, está agora recebendo uma revisão prioritária pela Food and Drug Administration (FDA) nos Estados Unidos. Na esteira da temporada de gripe deste ano, a mais severa nos Estados Unidos desde a epidemia de “gripe suína” de 2009-2010, médicos e consumidores estão procurando por melhores opções de tratamento. A última temporada de gripe foi agravada pelo fato de que a vacina contra influenza teve uma taxa de eficácia de 25% contra a cepa predominante da gripe chamada H3N2.
Agora, uma nova droga, o baloxavir marboxil – conhecido por seu nome comercial Xofluza no Japão – despertou o interesse de especialistas de todo o mundo como um novo desenvolvimento no tratamento da gripe.
A droga foi desenvolvida apenas recentemente pela empresa farmacêutica japonesa Shionogi e aprovada para uso no Japão em 23 de fevereiro de 2018, para adultos e crianças com 12 anos ou mais.
"Estamos satisfeitos que a FDA designou o Priority Review para o baloxavir marboxil, pois isso ressalta a necessidade de novas opções além dos tratamentos atualmente disponíveis", disse Mark Eisner, vice-presidente de desenvolvimento de produtos para imunologia, doenças infecciosas e oftalmologia da Genentech. uma declaração para Healthline.
Se aprovado, o baloxavir marboxil seria o primeiro antiviral oral de dose única e o primeiro medicamento com um novo mecanismo de ação proposto para tratar a gripe em quase 20 anos ”, disse ele.
Como esta droga é diferente? Ao contrário dos tratamentos tradicionais da gripe, como o oseltamivir (Tamiflu), que requerem inúmeras doses, a Xofluza requer apenas uma dose única de um comprimido oral após a infecção da gripe.
O medicamento foi licenciado pela Roche Pharmaceuticals e está sendo desenvolvido para o mercado nos Estados Unidos pela Genentech, a mesma empresa por trás do Tamiflu.
Xofluza está atualmente na fase III dos testes do FDA nos Estados Unidos e foi recentemente designada como “Priority Review” pelo FDA. Essa designação é dada a um medicamento que mostra melhorias significativas na segurança e na efetividade de doenças graves em comparação com outras em desenvolvimento.
A FDA declara que pretende tomar medidas sobre medicamentos de revisão prioritária dentro de seis meses e deve tomar uma decisão sobre a aprovação da Xofluza até dezembro deste ano.
Como o medicamento funciona? Xofluza funciona interrompendo a capacidade de um vírus se replicar, resultando em menor gravidade dos sintomas e diminuição da duração da doença. O mecanismo de ação do fármaco difere do Tamiflu e foi concebido para atingir tanto as estirpes de influenza A como B, bem como as estirpes resistentes ao Tamiflu.
Os testes realizados pela Shionogi envolveram 1.436 pacientes com gripe saudáveis ??e demonstraram vários resultados importantes de eficácia e segurança para a Xofluza. A droga diminuiu com sucesso o tempo de sintomas de mais de três dias (80,2 horas) no grupo placebo para cerca de dois e meio (53,7 horas). A resolução da febre também foi muito mais rápida: cerca de um dia com a Xofluza, em comparação com quase dois dias (42 horas) com o placebo.
Além disso, o tempo de "derramamento viral" – um indicador de como uma pessoa é contagiosa – foi significativamente menor, cerca de um dia, naqueles que tomam Xofluza, em comparação com quatro dias para aqueles no grupo placebo e três dias para aqueles que tomam oseltamivir.
A Shionogi publicou os resultados de seu estudo, conhecido como Capstone-1, um estudo duplo-cego, placebo e controlado por oseltamivir em setembro de 2017.
“Se tivermos um tratamento superior, podemos assegurar aos pacientes que, se começarem cedo após o início da doença, tomarem uma pílula para reduzir a gravidade da doença, a duração da doença e diminuir a probabilidade de disseminação aos outros, teremos algo novo e poderoso para dar aos nossos pacientes. Estou ansioso para poder fazer isso ”, disse o Dr. William Schaffner, professor de doenças infecciosas da Escola de Medicina da Universidade de Vanderbilt.
Schaffner não esteve envolvido no desenvolvimento da Xofluza. Enquanto Schaffner reiterou que a Xofluza é um desenvolvimento empolgante, ela não substitui a vacina contra a gripe e pede que todos os indivíduos sejam vacinados para a temporada de gripe.
"Deve ser responsabilidade social de todos não disseminar a gripe para os outros, e a maneira de fazer isso é vacinar, porque isso é a melhor coisa que você pode fazer", disse ele.
Ele ressaltou que mesmo os especialistas em doenças infecciosas não podem prever quão ruim será a temporada de gripe do próximo ano.
Embora mais pesquisas precisem ser feitas, Schaffner disse que esta nova medicação pode rapidamente se tornar popular no próximo inverno se funcionar.
"Se você tem um tratamento de dose única e é seguro, isso vai convencer muitos fornecedores a prescrever tratamento porque é muito fácil e rápido", disse Schaffner.
"Se puder ser demonstrado, de forma convincente, que a duração da doença é reduzida e que as complicações são evitadas, ela se tornará popular muito, muito rapidamente e fará muito bem".
Escrito por Gigen Mammoser em 6 de julho de 2018
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