Efficacy of sofosbuvir as treatment for yellow fever: protocol for a randomised controlled trial in Brazil (SOFFA study)

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Figueiredo-Mello, Claudia ^{[1, 2]} ; Boas Casadio, Luciana Vilas ^{[3, 4]} ; Avelino-Silva, Vivian Lida ^[2] ; Yeh-Li, Ho ; Sztajnbok, Jaques ^[5] ; Joelsons, Daniel ^[6] ; Antonio, Marilia Bordignon ^[2] ; Rebello Pinho, Joao Renato ^[3] ; Malta, Fernanda de Mello ^[3] ; Gomes-Gouvea, Michele Soares ^[3] ; Moreira Salles, Ana Paula ^[3] ; Cora, Aline Pivetta ^[7] ; Valente Moreira, Carlos Henrique ^[8] ; Ribeiro, Ana Freitas ^[9] ; de Seixas Santos Nastri, Ana Catharina ^{[3, 6]} ; Sant'Ana Malaque, Ceila Maria ^[5] ; Azevedo Teixeira, Ralcyon Francis ^[10] ; Sansao Borges, Luciana Marques ^[11] ; Gonzalez, Mario Peribanez ^[12] ; Pereira Junior, Luiz Carlos ^[13] ; Lobato Souza, Tamara Newman ^[14] ; Wan Song, Alice Tung ^[15] ; Carneiro D'Albuquerque, Luiz Augusto ^[15] ; Abdala, Edson ^{[6, 16]} ; Andraus, Wellington ^[15] ; de Martino, Rodrigo Bronze ^[15] ; Ducatti, Liliana ^[15] ; Andrade, Guilherme Marques ^[15] ; Se Malbouisson, Luiz Marcelo ^[15] ; de Souza, Izabel Marcilio ^[17] ; Carrilho, Flair Jose ^[15] ; Sabino, Ester Cerdeira ^[2] ; Levin, Anna S. ^[2]

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^[1] Inst Infectol Emilio Ribas, Dept Educ & Res, Sao Paulo, SP - Brazil

^[2] Univ Sao Paulo, Dept Infect & Parasit Dis, Fac Med FMUSP, Sao Paulo, SP - Brazil

^[3] Univ Sao Paulo, Dept Gastroenterol LIM07, Fac Med FMUSP, Sao Paulo, SP - Brazil

^[4] Univ Sao Paulo, Dept Infect & Parasit Dis, Hosp Clin HCFMUSP, Fac Med, Sao Paulo, SP - Brazil

^[5] Inst Infectol Emilio Ribas, Div Med, Intens Care Unit, Sao Paulo, SP - Brazil

^[6] Ho Yeh-Li, Univ Sao Paulo, Dept Infect & Parasit Dis, Hosp Clin HCFMUSP, Fac Med, Sao Paulo, SP - Brazil

^[7] Inst Infectol Emilio Ribas, Clin Lab, Sao Paulo, SP - Brazil

^[8] Inst Infectol Emilio Ribas, Inpatient Unit, Sao Paulo, SP - Brazil

^[9] Inst Infectol Emilio Ribas, Epidemiol Serv, Sao Paulo, SP - Brazil

^[10] Inst Infectol Emilio Ribas, Med Div, Sao Paulo, SP - Brazil

^[11] Inst Infectol Emilio Ribas, Med Emergency Dept, Sao Paulo, SP - Brazil

^[12] Inst Infectol Emilio Ribas, Outpatients Clin, Sao Paulo, SP - Brazil

^[13] Inst Infectol Emilio Ribas, Tech Dept, Sao Paulo, SP - Brazil

^[14] Inst Infectol Emilio Ribas, ER & Outpatient Serv, Sao Paulo, SP - Brazil

^[15] Univ Sao Paulo, Dept Gastroenterol, Hosp Clin HCFMUSP, Fac Med, Sao Paulo, SP - Brazil

^[16] Univ Sao Paulo, Infect Dis, Inst Canc Estado Sao Paulo, Sao Paulo, SP - Brazil

^[17] Univ Sao Paulo, Epidemiol Surveillance Dept, Hosp Clin, Sao Paulo, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: BMJ OPEN; v. 9, n. 11 NOV 2019.
• Citações Web of Science: 0

Resumo

Introduction An ongoing outbreak of yellow fever (YF) has been reported in Brazil with 1261 confirmed cases and 409 deaths since July 2017. To date, there is no specific treatment available for YF. Recently published papers describing in vitro and animal models suggest a potential effect of antiviral drugs (approved for the treatment of hepatitis virus) against flaviviruses, including YF. The primary aim of this study is to analyse the effect of sofosbuvir on viral kinetics and clinical outcomes among patients presenting with YE This is a multicentre open-label randomised controlled trial with 1:1 individual allocation, stratified by severity and by recruiting centre. Methods and analysis Adults with suspected or confirmed YF infection and symptoms lasting up to 15 days are screened. Eligible and consenting patients are randomised to receive oral sofosbuvir 400 mg daily for 10 days or to receive standard clinical care. Viral kinetics are measured daily and the reduction in YF plasma viral load from the sample at inclusion to 72 hours after randomisation will be compared between active and control groups. Clinical outcomes include severity meeting criteria for intensive care support, liver transplantation, in-hospital mortality and mortality within 60 days. (AU)

• Processo FAPESP: 16/01735-2 - Metagenômica viral de Dengue, Chikungunya e Zika vírus: acompanhar, explicar e prever a transmissão e distribuição espaço-temporal no Brasil
• Beneficiário: Ester Cerdeira Sabino
• Modalidade de apoio: Auxílio à Pesquisa - Regular