Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo-controlled randomized trial in healthcare workers

Objectives: To assess the effect of hydroxychloroquine (HCQ) and Tenofovir disoproxil fumarate/emtri-citabine (TDF/FTC) as pre-exposure prophylaxis on COVID-19 risk.Methods: EPICOS is a double-blind, placebo-controlled randomized trial conducted in Spain, Bolivia, and Venezuela. Healthcare workers w...

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Detalhes bibliográficos
Autores: Polo R, García-Albéniz X, Terán C, Morales M, Rial-Crestelo D, Garcinuño MA, García Del Toro M, Hita C, Gómez-Sirvent JL, Buzón L, Díaz de Santiago A, Pérez Arellano JL, Sanz J, Bachiller P, Martínez Alfaro E, Díaz-Brito V, Masiá M, Hernández-Torres A, Guerra J, Santos J, Arazo P, Muñoz L, Arribas JR, Martínez de Salazar P, Moreno S, Hernán MA, Del Amo J, Rosa Polo, Berenguer J, Martínez E, Hernán M, García de Albéniz X
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p13909
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/13909
Access Level:acceso abierto
Palavra-chave:COVID-19
Pre-exposure prophylaxis
Randomized clinical trial
SARS-CoV-2
Tenofovir
Descrição
Resumo:Objectives: To assess the effect of hydroxychloroquine (HCQ) and Tenofovir disoproxil fumarate/emtri-citabine (TDF/FTC) as pre-exposure prophylaxis on COVID-19 risk.Methods: EPICOS is a double-blind, placebo-controlled randomized trial conducted in Spain, Bolivia, and Venezuela. Healthcare workers with negative SARS-CoV-2 IgM/IgG test were randomly assigned to the following: daily TDF/FTC plus HCQ for 12 weeks, TDF/FTC plus HCQ placebo, HCQ plus TDF/FTC placebo, and TDF/FTC placebo plus HCQ placebo. Randomization was performed in groups of four. Primary outcome was laboratory-confirmed, symptomatic COVID-19. We also studied any (symptomatic or asymptomatic) COVID-19. We compared group-specific 14-week risks via differences and ratios with 95% CIs.Results: Of 1002 individuals screened, 926 (92.4%) were eligible and there were 14 cases of symptomatic COVID-19: 220 were assigned to the TDF/FTC plus HCQ group (3 cases), 231 to the TDF/FTC placebo plus HCQ group (3 cases), 233 to the TDF/FTC plus HCQ placebo group (3 cases), and 223 to the double placebo group (5 cases). Compared with the double placebo group, 14-week risk ratios (95% CI) of symptomatic COVID-19 were 0.39 (0.00-1.98) for TDF + HCQ, 0.34 (0.00-2.06) for TDF, and 0.49 (0.00-2.29) for HCQ. Corresponding risk ratios of any COVID-19 were 0.51 (0.21-1.00) for TDF + HCQ, 0.81 (0.44-1.49) for TDF, and 0.73 (0.41-1.38) for HCQ. Adverse events were generally mild.Discussion: The target sample size was not met. Our findings are compatible with both benefit and harm of pre-exposure prophylaxis with TDF/FTC and HCQ, alone or in combination, compared with placebo. Rosa Polo, Clin Microbiol Infect 2023;29:85 & COPY; 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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