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

Autor:	Figueiredo-Mello C; Department of Education and Research, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil claudiamello@ymail.com.; Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Casadio LVB; Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.; Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil., Avelino-Silva VI; Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Yeh-Li H; Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Sztajnbok J; Medical Division-Intensive Care Unit, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Joelsons D; Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Antonio MB; Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Pinho JRR; Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil., Malta FM; Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil., Gomes-Gouvêa MS; Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil., Salles APM; Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil., Corá AP; Clinical Lab, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Moreira CHV; Inpatient Unit, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Ribeiro AF; Epidemiology Service, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Nastri ACSS; Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.; Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil., Malaque CMS; Medical Division-Intensive Care Unit, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Teixeira RFA; Medical Division, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Borges LMS; Medical Emergency Department, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Gonzalez MP; Outpatients Clinic, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Junior LCP; Technical Department, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Souza TNL; ER and Outpatient Service, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil., Song ATW; Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., D'Albuquerque LAC; Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Abdala E; Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.; Infectious Diseases, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, SP, Brazil., Andraus W; Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Martino RB; Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Ducatti L; Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Andrade GM; Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Malbouisson LMS; Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Souza IM; Epidemiologic Surveillance Department, Universidade de São Paulo Hospital das Clínicas, Sao Paulo, SP, Brazil., Carrilho FJ; Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Sabino EC; Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Levin AS; Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2019 Nov 25; Vol. 9 (11), pp. e027207. Date of Electronic Publication: 2019 Nov 25.
DOI:	10.1136/bmjopen-2018-027207
Abstrakt:	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). Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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