RT Journal Article
T1 Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo-controlled randomized trial in healthcare workers.
A1 Polo, Rosa
A1 García-Albéniz, Xabier
A1 Terán, Carolina
A1 Morales, Miguel
A1 Rial-Crestelo, David
A1 Garcinuño, M Angeles
A1 García Del Toro, Miguel
A1 Hita, César
A1 Gómez-Sirvent, Juan Luis
A1 Buzón, Luis
A1 Díaz de Santiago, Alberto
A1 Arellano, Jose Pérez
A1 Sanz, Jesus
A1 Bachiller, Pablo
A1 Alfaro, Elisa Martínez
A1 Díaz-Brito, Vicente
A1 Masiá, Mar
A1 Hernández-Torres, Alicia
A1 Guerra, Jose M
A1 Santos, Jesús
A1 Arazo, Piedad
A1 Muñoz, Leopoldo
A1 Arribas, Jose Ramon
A1 Martínez de Salazar, Pablo
A1 Moreno, Santiago
A1 Hernán, Miguel A
A1 Del Amo, Julia
A1 EPICOS, 
K1 COVID-19
K1 Pre-exposure prophylaxis
K1 Randomized clinical trial
K1 SARS-CoV-2
K1 Tenofovir
AB To assess the effect of hydroxychloroquine (HCQ) and Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis on COVID-19 risk. 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. 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. 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.
YR 2022
FD 2022-08-05
LK http://hdl.handle.net/10668/22134
UL http://hdl.handle.net/10668/22134
LA en
DS RISalud
RD Apr 11, 2025