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Title: Efficacy of sofosbuvir as treatment for yellow fever: protocol for a randomised controlled trial in Brazil (SOFFA study)
Authors: FIGUEIREDO-MELLO, ClaudiaCASADIO, Luciana Vilas BoasAVELINO-SILVA, Vivian LidaHo Yeh-LiSZTAJNBOK, JaquesJOELSONS, DanielANTONIO, Marilia BordignonPINHO, Joao Renato RebelloMALTA, Fernanda de MelloGOMES-GOUVEA, Michele SoaresSALLES, Ana Paula MoreiraCORA, Aline PivettaMOREIRA, Carlos Henrique ValenteRIBEIRO, Ana FreitasNASTRI, Ana Catharina de Seixas SantosMALAQUE, Ceila Maria Sant'AnaTEIXEIRA, Ralcyon Francis AzevedoBORGES, Luciana Marques SansaoGONZALEZ, Mario PeribanezPEREIRA JUNIOR, Luiz CarlosSOUZA, Tamara Newman LobatoSONG, Alice Tung WanD'ALBUQUERQUE, Luiz Augusto CarneiroABDALA, EdsonANDRAUS, WellingtonMARTINO, Rodrigo Bronze deDUCATTI, LilianaANDRADE, Guilherme MarquesMALBOUISSON, Luiz Marcelo SeSOUZA, Izabel Marcilio deCARRILHO, Flair JoseSABINO, Ester CerdeiraLEVIN, Anna S.
Citation: BMJ OPEN, v.9, n.11, article ID e027207, 5p, 2019
Abstract: 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.
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Artigos e Materiais de Revistas Científicas - FM/MGT
Departamento de Gastroenterologia - FM/MGT

Artigos e Materiais de Revistas Científicas - FM/MIP
Departamento de Moléstias Infecciosas e Parasitárias - FM/MIP

Artigos e Materiais de Revistas Científicas - HC/ICHC
Instituto Central - HC/ICHC

Artigos e Materiais de Revistas Científicas - LIM/03
LIM/03 - Laboratório de Medicina Laboratorial

Artigos e Materiais de Revistas Científicas - LIM/07
LIM/07 - Laboratório de Gastroenterologia Clínica e Experimental

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LIM/08 - Laboratório de Anestesiologia

Artigos e Materiais de Revistas Científicas - LIM/37
LIM/37 - Laboratório de Transplante e Cirurgia de Fígado

Artigos e Materiais de Revistas Científicas - LIM/46
LIM/46 - Laboratório de Parasitologia Médica

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LIM/47 - Laboratório de Hepatologia por Vírus

Artigos e Materiais de Revistas Científicas - LIM/49
LIM/49 - Laboratório de Protozoologia

Artigos e Materiais de Revistas Científicas - ODS/03
ODS/03 - Saúde e bem-estar

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