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

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 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).

SUBMITTER: Figueiredo-Mello C

PROVIDER: S-EPMC6887076 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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

Figueiredo-Mello Claudia C Casadio Luciana Vilas Boas LVB Avelino-Silva Vivian Iida VI Yeh-Li Ho H Sztajnbok Jaques J Joelsons Daniel D Antonio Marilia Bordignon MB Pinho João Renato Rebello JRR Malta Fernanda de Mello FM Gomes-Gouvêa Michele Soares MS Salles Ana Paula Moreira APM Corá Aline Pivetta AP Moreira Carlos Henrique Valente CHV Ribeiro Ana Freitas AF Nastri Ana Catharina de Seixas Santos ACSS Malaque Ceila Maria Sant'Ana CMS Teixeira Ralcyon Francis Azevedo RFA Borges Luciana Marques Sansão LMS Gonzalez Mario Peribañez MP Junior Luiz Carlos Pereira LCP Souza Tâmara Newman Lobato TNL Song Alice Tung Wan ATW D'Albuquerque Luiz Augusto Carneiro LAC Abdala Edson E Andraus Wellington W Martino Rodrigo Bronze de RB Ducatti Liliana L Andrade Guilherme Marques GM Malbouisson Luiz Marcelo Sá LMS Souza Izabel Marcilio de IM Carrilho Flair José FJ Sabino Ester Cerdeira EC Levin Anna S AS

BMJ open 20191125 11

<h4>Introduction</h4>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 ...[more]

PMID: 31772079

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Project description:BackgroundYellow fever virus is a mosquito-borne flavivirus that persists in an enzoonotic cycle in non-human primates (NHPs) in Brazil, causing disease in humans through spillover events. Yellow fever (YF) re-emerged in the early 2000s, spreading from the Amazon River basin towards the previously considered low-risk, southeastern region of the country. Previous methods mapping YF spillover risk do not incorporate the temporal dynamics and ecological context of the disease, and are therefore unable to predict seasonality in spatial risk across Brazil. We present the results of a bagged logistic regression predicting the propensity for YF spillover per municipality (administrative sub-district) in Brazil from environmental and demographic covariates aggregated by month. Ecological context was incorporated by creating National and Regional models of spillover dynamics, where the Regional model consisted of two separate models determined by the regions' NHP reservoir species richness (high vs low).ResultsOf the 5560 municipalities, 82 reported YF cases from 2001 to 2013. Model accuracy was high for the National and low reservoir richness (LRR) models (AUC = 0.80), while the high reservoir richness (HRR) model accuracy was lower (AUC = 0.63). The National model predicted consistently high spillover risk in the Amazon, while the Regional model predicted strong seasonality in spillover risk. Within the Regional model, seasonality of spillover risk in the HRR region was asynchronous to the LRR region. However, the observed seasonality of spillover risk in the LRR Regional model mirrored the national model predictions.ConclusionsThe predicted risk of YF spillover varies with space and time. Seasonal trends differ between regions indicating, at times, spillover risk can be higher in the urban coastal regions than the Amazon River basin which is counterintuitive based on current YF risk maps. Understanding the spatio-temporal patterns of YF spillover risk could better inform allocation of public health services.

Project description:IntroductionPrevious research has shown that it is feasible to integrate motivational interviewing techniques with behavioural and psychological interventions for the treatment of obesity. Moreover, these combined interventions have the potential to improve health-related outcomes of people living with obesity (PLWO) and to afford maintenance of behavioural changes over time. In addition, the use of virtual reality (VR) embodiment techniques in the treatment of eating disorders and obesity has promising preliminary effectiveness. The objective of this study is to assess the clinical efficacy of a VR intervention that uses embodiment and body-swapping techniques and has been specifically developed to cover the needs of PLWO.Methods and analysisA randomised control trial will be carried out with an estimated sample of 96 participants with body mass index (BMI)>30. The whole duration of the trial will be 12 months. Participants will be recruited from the external consultations of the Vall d'Hebron University Hospital and be randomly assigned to three groups. The experimental group 1 will engage in a virtual self-conversation using the ConVRself platform, the experimental group 2 will participate in a 'pre-established discourse' provided by the virtual counsellor, who will give psychoeducation advice, and the control group will continue with treatment as usual. Readiness to change, BMI, eating habits and physical activity, psychological well-being, body image satisfaction, quality of life in relation to body image, and weight bias internalisation will be assessed at baseline, post intervention, 1-week and 4-week follow-up. Finally, variables related to adherence and satisfaction with the VR tool will be evaluated for the experimental groups.Ethics and disseminationThis study was approved by the Research Projects Committee of the Vall d'Hebron University Hospital. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences and other events for the scientific and clinical community, and the general public.Trial registration numberNCT05094557.

Dataset Information

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

Publications

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

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