Ayerdi Oskar, Puerta Teresa, Clavo Petunia, Vera Mar, Ballesteros Juan, Fuentes Manuel Enrique, Estrada Vicente, Rodríguez Carmen, Del Romero Jorge
Centro Sanitario Sandoval, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Madrid, Spain.
Servicio de Medicina Preventiva, Instituto de Investigación Sanitaria San Carlos, Universidad Alfonso X el Sabio, Madrid, Spain.
Open Forum Infect Dis. 2020 Sep 25;7(11):ofaa455. doi: 10.1093/ofid/ofaa455. eCollection 2020 Nov.
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.
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.
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 ( = .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) ( = .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 ( = .070). In users of TDF/FTC the figure was 53.3% and in users of TAF/FTC the figure was 73.3% ( = .100). The duration of symptoms was 11.5 days in the control group, 9.0 days in PrEP users ( = .116), 7.0 days in users of TDF/FTC, and 13.0 days in users of TAF/FTC ( = .100).
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.
替诺福韦/恩曲他滨（FTC）对人类免疫缺陷病毒阴性人群预防严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的效果尚不清楚。本研究旨在分析暴露前预防用药（PrEP）、富马酸替诺福韦二吡呋酯/恩曲他滨（TDF/FTC）或替诺福韦艾拉酚胺（TAF）/FTC使用者中新型冠状病毒肺炎（COVID-19）的血清流行率及临床表现，并与对照组进行比较。
2020年5月11日至2020年6月27日，对未使用PrEP的男男性行为者和变性女性（第1组；n = 250）以及使用TDF/FTC（n = 409）或TAF/FTC（n = 91）的PrEP使用者（第2组；n = 500）进行了SARS-CoV-2抗体血清流行率的观察性描述性研究。所有参与者均填写一份结构化问卷，收集待分析变量的信息，然后进行SARS-CoV-2免疫球蛋白G抗体检测（化学发光微粒子免疫分析）。
未使用PrEP组的SARS-CoV-2血清流行率为9.2%（95%置信区间[CI]，5.9 - 13.5），PrEP使用者组为15.0%（95% CI，12.0 - 18.4）（P = 0.026）。TDF/FTC使用者中为14.7%（95% CI，11.4 - 18.5），TAF/FTC使用者中为16.5%（95% CI，9.5 - 25.7）（P = 0.661）。SARS-CoV-2检测呈阳性且接受PrEP的患者中，57.4%出现症状，而对照组为78.3%（P = 0.070）。TDF/FTC使用者中这一比例为53.3%，TAF/FTC使用者中为73.3%（P = 0.100）。对照组症状持续时间为11.5天，PrEP使用者为9.0天（P = 0.116），TDF/FTC使用者为7.0天，TAF/FTC使用者为13.0天（P = 0.100）。
PrEP、TDF/FTC或TAF/FTC使用者的SARS-CoV-2血清流行率高于对照组。在临床表现方面未发现统计学上的显著差异。PrEP使用者应采取与普通人群相同的预防措施。
