PT  - JOURNAL ARTICLE
AU  - Figueiredo-Mello, Claudia
AU  - Casadio, Luciana Vilas Boas
AU  - Avelino-Silva, Vivian Iida
AU  - Yeh-Li, Ho
AU  - Sztajnbok, Jaques
AU  - Joelsons, Daniel
AU  - Antonio, Marilia Bordignon
AU  - Pinho, João Renato Rebello
AU  - Malta, Fernanda de Mello
AU  - Gomes-Gouvêa, Michele Soares
AU  - Salles, Ana Paula Moreira
AU  - Corá, Aline Pivetta
AU  - Moreira, Carlos Henrique Valente
AU  - Ribeiro, Ana Freitas
AU  - Nastri, Ana Catharina de Seixas Santos
AU  - Malaque, Ceila Maria Sant'Ana
AU  - Teixeira, Ralcyon Francis Azevedo
AU  - Borges, Luciana Marques Sansão
AU  - Gonzalez, Mario Peribañez
AU  - Junior, Luiz Carlos Pereira
AU  - Souza, Tâmara Newman Lobato
AU  - Song, Alice Tung Wan
AU  - D'Albuquerque, Luiz Augusto Carneiro
AU  - Abdala, Edson
AU  - Andraus, Wellington
AU  - Martino, Rodrigo Bronze de
AU  - Ducatti, Liliana
AU  - Andrade, Guilherme Marques
AU  - Malbouisson, Luiz Marcelo Sá
AU  - Souza, Izabel Marcilio de
AU  - Carrilho, Flair José
AU  - Sabino, Ester Cerdeira
AU  - Levin, Anna S
TI  - Efficacy of sofosbuvir as treatment for yellow fever: protocol for a randomised controlled trial in Brazil (SOFFA study)
AID  - 10.1136/bmjopen-2018-027207
DP  - 2019 Nov 01
TA  - BMJ Open
PG  - e027207
VI  - 9
IP  - 11
4099  - http://bmjopen.bmj.com/content/9/11/e027207.short
4100  - http://bmjopen.bmj.com/content/9/11/e027207.full
SO  - BMJ Open2019 Nov 01; 9
AB  - 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 YF. 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.Ethics and dissemination Ethics approval was obtained at the participating sites and at the national research ethics committee (CAAE 82673018.6.1001.0068). The trial has been submitted for ethical approval at additional potential recruiting centres. Results of the study will be published in journals and presented at scientific meetings.Trial registration Brazilian Clinical Trials Registry (RBR-93dp9n).