Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo-controlled randomized trial in healthcare workers
| Autor: | Rosa Polo, Xabier García-Albéniz, Carolina Terán, Miguel Morales, David Rial-Crestelo, M. Angeles Garcinuño, Miguel García del Toro, César Hita, Juan Luis Gómez-Sirvent, Luis Buzón, Alberto Díaz de Santiago, Jose Pérez Arellano, Jesus Sanz, Pablo Bachiller, Elisa Martínez Alfaro, Vicente Díaz-Brito, Mar Masiá, Alicia Hernández-Torres, Jose M. Guerra, Jesús Santos, Piedad Arazo, Leopoldo Muñoz, Jose Ramon Arribas, Pablo Martínez de Salazar, Santiago Moreno, Miguel A. Hernán, Julia Del Amo, null Julia del Amo, Juan Berenguer, Esteban Martínez, Miguel Hernán, Xabier García de Albéniz |
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| Rok vydání: | 2023 |
| Předmět: |
Microbiology (medical)
SARS-CoV-2 Anti-HIV Agents Adenine Health Personnel Organophosphonates COVID-19 Pre-exposure prophylaxis HIV Infections General Medicine Deoxycytidine COVID-19 Drug Treatment Infectious Diseases Double-Blind Method Humans Emtricitabine Pre-Exposure Prophylaxis Randomized clinical trial Tenofovir Hydroxychloroquine |
| Zdroj: | Clinical Microbiology and Infection. 29:85-93 |
| ISSN: | 1198-743X |
| DOI: | 10.1016/j.cmi.2022.07.006 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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