Preventive Efficacy of Tenofovir/Emtricitabine Against Severe Acute Respiratory Syndrome Coronavirus 2 Among Pre-Exposure Prophylaxis Users

Oskar Ayerdi; Teresa Puerta; Petunia Clavo; Mar Vera; Juan Ballesteros; Manuel Enrique Fuentes; Vicente Estrada; Carmen Rodríguez; Jorge Del Romero; Sandoval Study Group

doi:10.1093/ofid/ofaa455

Preventive Efficacy of Tenofovir/Emtricitabine Against Severe Acute Respiratory Syndrome Coronavirus 2 Among Pre-Exposure Prophylaxis Users

Open Forum Infect Dis. 2020 Sep 25;7(11):ofaa455. doi: 10.1093/ofid/ofaa455. eCollection 2020 Nov.

Authors

Oskar Ayerdi¹, Teresa Puerta¹, Petunia Clavo¹, Mar Vera¹, Juan Ballesteros¹, Manuel Enrique Fuentes², Vicente Estrada³, Carmen Rodríguez¹, Jorge Del Romero¹; Sandoval Study Group

Collaborators

Sandoval Study Group:
Jorge Del Romero, Carmen Rodríguez, Teresa Puerta, Petunia Clavo, Mar Vera, Juan Ballesteros, Clara Lejarraga, Nuria Fernández, Estefanía Hurtado, Mónica García, Montserrat González, Natividad Jerez, Florencia Alcudia, Maria Teresa Jiménez, Elisa Torres, Iria de Domingo, Ruth Lázaro, Montserrat Raposo, Oskar Ayerdi

Affiliations

¹ Centro Sanitario Sandoval, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Madrid, Spain.
² Servicio de Medicina Preventiva, Instituto de Investigación Sanitaria San Carlos, Universidad Alfonso X el Sabio, Madrid, Spain.
³ Servicio de Infecciosas, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Madrid, Spain.

Abstract

Background: The preventive effect that tenofovir/emtricitabine (FTC) could have against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human immunodeficiency virus-negative people is unknown. The objective of this study was to analyze the seroprevalence and clinical manifestations of COVID-19 among users of pre-exposure prophylaxis (PrEP), disoproxil fumarate/FTC (TDF/FTC), or tenofovir alafenamide (TAF)/FTC and to compare it to that of a control group.

Methods: An observational descriptive study of the seroprevalence of antibodies for SARS-CoV-2 among men who have sex with men and transgender women without use of PrEP (Group 1; n = 250) and PrEP users with TDF/FTC (n = 409) or TAF/FTC (n = 91) (Group 2; n = 500) was conducted from May11, 2020 to June 27, 2020. All participants were provided with a structured questionnaire that collected information on the variables to be analyzed, and testing for immunoglobulin G antibodies to SARS-CoV-2 (chemiluminescent microparticle immunoassay) was then carried out.

Results: The seroprevalence of SARS-CoV-2 was 9.2% (95% confidence interval [CI], 5.9-13.5) in the group without PrEP and 15.0% (95% CI, 12.0-18.4) in the group with PrEP (P = .026). Among users of TDF/FTC it was 14.7% (95% CI, 11.4-18.5), and in users of TAF/FTC it was 16.5% (95% CI, 9.5-25.7) (P = .661). In those who tested positive for SARS-CoV-2 and receiving PrEP, 57.4% manifested symptoms, compared with 78.3% in the control group (P = .070). In users of TDF/FTC the figure was 53.3% and in users of TAF/FTC the figure was 73.3% (P = .100). The duration of symptoms was 11.5 days in the control group, 9.0 days in PrEP users (P = .116), 7.0 days in users of TDF/FTC, and 13.0 days in users of TAF/FTC (P = .100).

Conclusions: Users of PrEP, TDF/FTC, or TAF/FTC presented a higher seroprevalence to SARS-CoV-2 than the control group. No statistically significant differences were found in relation to clinical manifestations. The PrEP users should use the same prevention measures as those indicated for the general population.

Keywords: COVID-19; SARS-CoV-2; disoproxil fumarate/emtricitabine (TDF/FTC); pre-exposure prophylaxis (PrEP); tenofovir alafenamide/emtricitabine (TAF/FTC).