Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19 : a double-blind placebo-controlled randomized trial in healthcare workers
Copyright © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved..
OBJECTIVES: To assess the effect of hydroxychloroquine (HCQ) and Tenofovir disoproxil fumarate/emtricitabine (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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:29 |
|---|---|
| Enthalten in: |
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases - 29(2023), 1 vom: 01. Jan., Seite 85-93 |
| Sprache: |
Englisch |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 27.12.2022 Date Revised 30.12.2022 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.cmi.2022.07.006 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM344600041 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM344600041 | ||
| 003 | DE-627 | ||
| 005 | 20231226023140.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.cmi.2022.07.006 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1148.xml |
| 035 | |a (DE-627)NLM344600041 | ||
| 035 | |a (NLM)35940567 | ||
| 035 | |a (PII)S1198-743X(22)00370-6 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Polo, Rosa |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19 |b a double-blind placebo-controlled randomized trial in healthcare workers |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 27.12.2022 | ||
| 500 | |a Date Revised 30.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved. | ||
| 520 | |a OBJECTIVES: To assess the effect of hydroxychloroquine (HCQ) and Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis on COVID-19 risk | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Pre-exposure prophylaxis | |
| 650 | 4 | |a Randomized clinical trial | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a Tenofovir | |
| 650 | 7 | |a Tenofovir |2 NLM | |
| 650 | 7 | |a 99YXE507IL |2 NLM | |
| 650 | 7 | |a Emtricitabine |2 NLM | |
| 650 | 7 | |a G70B4ETF4S |2 NLM | |
| 650 | 7 | |a Hydroxychloroquine |2 NLM | |
| 650 | 7 | |a 4QWG6N8QKH |2 NLM | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a Adenine |2 NLM | |
| 650 | 7 | |a JAC85A2161 |2 NLM | |
| 650 | 7 | |a Organophosphonates |2 NLM | |
| 650 | 7 | |a Deoxycytidine |2 NLM | |
| 650 | 7 | |a 0W860991D6 |2 NLM | |
| 700 | 1 | |a García-Albéniz, Xabier |e verfasserin |4 aut | |
| 700 | 1 | |a Terán, Carolina |e verfasserin |4 aut | |
| 700 | 1 | |a Morales, Miguel |e verfasserin |4 aut | |
| 700 | 1 | |a Rial-Crestelo, David |e verfasserin |4 aut | |
| 700 | 1 | |a Garcinuño, M Angeles |e verfasserin |4 aut | |
| 700 | 1 | |a García Del Toro, Miguel |e verfasserin |4 aut | |
| 700 | 1 | |a Hita, César |e verfasserin |4 aut | |
| 700 | 1 | |a Gómez-Sirvent, Juan Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Buzón, Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Díaz de Santiago, Alberto |e verfasserin |4 aut | |
| 700 | 1 | |a Arellano, Jose Pérez |e verfasserin |4 aut | |
| 700 | 1 | |a Sanz, Jesus |e verfasserin |4 aut | |
| 700 | 1 | |a Bachiller, Pablo |e verfasserin |4 aut | |
| 700 | 1 | |a Alfaro, Elisa Martínez |e verfasserin |4 aut | |
| 700 | 1 | |a Díaz-Brito, Vicente |e verfasserin |4 aut | |
| 700 | 1 | |a Masiá, Mar |e verfasserin |4 aut | |
| 700 | 1 | |a Hernández-Torres, Alicia |e verfasserin |4 aut | |
| 700 | 1 | |a Guerra, Jose M |e verfasserin |4 aut | |
| 700 | 1 | |a Santos, Jesús |e verfasserin |4 aut | |
| 700 | 1 | |a Arazo, Piedad |e verfasserin |4 aut | |
| 700 | 1 | |a Muñoz, Leopoldo |e verfasserin |4 aut | |
| 700 | 1 | |a Arribas, Jose Ramon |e verfasserin |4 aut | |
| 700 | 1 | |a Martínez de Salazar, Pablo |e verfasserin |4 aut | |
| 700 | 1 | |a Moreno, Santiago |e verfasserin |4 aut | |
| 700 | 1 | |a Hernán, Miguel A |e verfasserin |4 aut | |
| 700 | 1 | |a Del Amo, Julia |e verfasserin |4 aut | |
| 700 | 0 | |a EPICOS |e verfasserin |4 aut | |
| 700 | 1 | |a Julia Del Amo |e investigator |4 oth | |
| 700 | 1 | |a Polo, Rosa |e investigator |4 oth | |
| 700 | 1 | |a Moreno, Santiago |e investigator |4 oth | |
| 700 | 1 | |a Berenguer, Juan |e investigator |4 oth | |
| 700 | 1 | |a Martínez, Esteban |e investigator |4 oth | |
| 700 | 1 | |a Hernán, Miguel |e investigator |4 oth | |
| 700 | 1 | |a Martínez de Salazar, Pablo |e investigator |4 oth | |
| 700 | 1 | |a García de Albéniz, Xabier |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases |d 1995 |g 29(2023), 1 vom: 01. Jan., Seite 85-93 |w (DE-627)NLM094580014 |x 1469-0691 |7 nnns |
| 773 | 1 | 8 | |g volume:29 |g year:2023 |g number:1 |g day:01 |g month:01 |g pages:85-93 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.cmi.2022.07.006 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 29 |j 2023 |e 1 |b 01 |c 01 |h 85-93 | ||