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Home > Press Releases Translations

Nova terapia com combinação de tratamentos mais acessível economicamente contra a hepatite C, apresenta 97% de taxa de cura

Home > Press Releases Translations

Nova terapia com combinação de tratamentos mais acessível economicamente contra a hepatite C, apresenta 97% de taxa de cura

Healthcare worker examines liver of hepatitis C patient in Thailand
Paris, França — 12 Apr 2018
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Resultados refoçam uma abordagem de saúde pública para a hepatite C  

Uma nova terapia, com combinação de dois diferentes tratamentos, e com custo mais acessível para o tratamento da hepatite C demonstrou segurança e eficácia, com taxas de cura extremamente altas entre os pacientes, incluindo casos difíceis de tratar. O tatameto inclui um novo candidato a fármaco, ravidasvir, e os resultados provisórios são do estudo Fase II/III STORM-C-1, apresentado pela organização de pesquisa e desenvolvimento sem fins lucrativos (Iniciativa Medicamentos para Doenças Negligenciadas (DNDi, pelas siglas em inglês de Drugs for Neglected Diseases initiative) – DNDi) durante a International Liver Conference, que acontece até  dia 15 de abril em Paris.

“Os resultados indicam que a combinação sofosbuvir/ravidasvir é comparável às melhores terapias para hepatite C atualmente disponíveis, porém a um preço acessível, o que pode oferecer uma alternativa viável em países excluídos dos programas de acesso das empresas farmacêuticas“, disse Dr. Bernard Pécoul, Diretor Executivo da DNDi.

O estudo utilizou medicamentos produzidos pela farmacêutica egípcia Pharco Pharmaceuticals, e foi realizado pela DNDi, com copatrocínio do Ministério da Saúde da Malásia, em dez centros de estudos na Malásia e na Tailândia. Os acordos, assinados em 2016 e 2017, que permitiram a realização dos estudos e o aumento de número de pacientes na Malásia, estabeleceram um valor de US$300 para o tratamento de 12 semanas, o que representa redução de quase 100% no valor dos tratamentos disponíveis hoje no país.

“Uma vez que a hepatite C se tornou um grande problema de saúde pública na Malásia, é fundamental expandir o acesso ao tratamento de forma a beneficiar a população“, disse o Dr. Datuk Noor Hisham Abdullah, diretor-geral de saúde do Ministério da Saúde da Malásia.  Em setembro de 2017, o governo da Malásia emitiu uma licença de “uso governamental” de patentes do sofosbuvir para permitir que 400.000 pessoas que vivem com a doença no país tenham acesso a medicamentos genéricos contra a hepatite C nos hospitais públicos.

A DNDi conduziu o estudo clínico aberto (com informações do tratamento á equipe medica e aos pacientes)  STORM-C-1 para avaliar a eficácia, segurança, tolerância e farmacocinética do medicamento candidato ravidasvir, combinado com sofosbuvir. De 301 adultos cronicamente infectados, os pacientes sem cirrose hepática foram tratados com a combinação ravidasvir/sofosbuvir por 12 semanas, e os pacientes com cirrose compensada receberam o tratamento por 24 semanas. De acordo com os padrões internacionais que definem a cura para os tratamentos de hepatite C, 12 semanas após o término do tratamento 97% dos inscritos foram curados (95% CI: 94,4-98,6). As taxas de cura foram significativamente altas, mesmo entre os pacientes mais difíceis de tratar: pacientes com cirrose hepática (96% curados); pacientes vivendo com HIV e utilizando seus medicamentos usuais (97%); pacientes infectados com genótipo 3 (97%), incluindo os com cirrose (96%); e pacientes previamente expostos a tratamentos de HCV (96%). É importante ressaltar que os pacientes que apresentaram uma combinação de diversos desses fatores de risco foram curados, sem que houvesse sinais inesperados de comprometimento de segurança.

Figure: STORM-C-1 : SVR12 rates overall and per pre-defined sub groups-Intend to treat analysis
STORM-C-1: Taxas de SVR12 globais e por subgrupos predefinidos – análise de intenção de tratar

“Do ponto de vista do provedor do tratamento a situação é muito encorajadora, pois estávamos aguardando o surgimento de um tratamento robusto, acessível e simples, tolerado por todos os grupos de pacientes, incluindo os que atualmente obtém menos resultados, como pacientes sob terapia anti-retroviral“, disse Pierre Mendiharat, Vice-Diretor de Operações  dos Médicos Sem Fronteiras (MSF). “Isso será crucial para expandir o tratamento para as categorias mais vulneráveis nos países em desenvolvimento“. MSF e DNDi trabalham em conjunto parade aumentar o acesso à atenção e ao tratamento  para pacientes com HCV em países de baixa e média renda por meio do projeto STORM-C, financiado pela iniciativa de Capacitação para o Investimento Transformacional (TIC) de MSF.

Mais de 71 milhões de pessoas vivem com hepatite C no mundo. A doença causa 400.000 óbitos por ano. Embora já existam tratamentos altamente eficazes há vários anos, menos de três milhões de pessoas estão sendo tratadas, e o número de pessoas infectadas a cada ano ultrapassa o número de indivíduos tratados. A Organização Mundial da Saúde pretende que 80% das pessoas diagnosticadas com HCV tenham iniciado tratamento até 2030.

O Ravidasvir é um inibidor oral de NS5A licenciado para a DNDi pela Presidio Pharmaceuticals. A maioria das pessoas incluídas no estudo da DNDi na Malásia e Tailândia tinham genótipo 1 (42% dos participantes) ou o genótipo 3 (53%), confirmando a eficácia da combinação para esses dois genótipos adicionais. Esses genótipos, 1 e 3, são os mais prevalentes na América Latina, especialmente na Argentina, no Brasil e no Chile. Outros estudos estão planejados para documentar a eficácia e segurança da combinação nos pacientes infectados com os outros genótipos do HCV e em grupos especialmente vulneráveis, de forma a permitir uma abordagem de saúde pública para o tratamento da hepatite C

“A Pharco se orgulha de viabilizar uma abordagem de saúde pública para o tratamento da hepatite C, por meio de terapias acessíveis. Esperamos ansiosamente por colaborações futuras em estudos clínicos adicionais para confirmar a segurança e a eficácia do ravidasvir”, disse o Dr. Sherine Helmy, CEO da Pharco.

Contatos de mídia

  • DNDi: Ilan Moss, +1 646 266 5216, imoss@dndi.org / media@dndi.org
  • DNDi América Latina: Marcela Dobarro, +55 21 98114 9429, mdobarro@dndi.org

 

Referências aos pôsteres

I. Andrieux-Meyer, S.S.Tan, N. Salvadori, F. Simon, T.R. Cressey, MS Rosaida, Abu Hassan MR, H. Omar, H. P. Tee, W.K. Chan, Suresh K., S. Thongsawat, K. Thetket, A. Avihingsanon, S. Khemnark, S. Thanprasertsuk, J-M. Piedagnel, Sasikala S., Nur Asimah Z.A, N. Da Silva, J. Brenner, B. Pécoul, M. Lallemant and Shahnaz M. Safety and efficacy of ravidasvir plus sofosbuvir 12 weeks in non-cirrhotic and 24 weeks in cirrhotic patients with hepatitis C virus genotypes 1, 2, 3 and 6: the STORM-C-1 phase II/III trial. International Liver Congress, Paris, April 11-15 2018,  France. Poster LBP-032

Sobre a DNDi

A iniciativa de Drogas para Doenças Negligenciadas (DNDi) é uma organização de P&D, sem fins lucrativos, que trabalha para oferecer novos tratamentos a pacientes negligenciados, especialmente para a doença do sono, doença de Chagas, leishmaniose, filária, HIV/AIDS em pacientes pediátricos e hepatite C. www.dndi.org

Photo crédit: Suriyan Tanasri-DNDi

Hepatitis C

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