Clinical Features, Pathobiology, Efficacy, and Toxicity of Tenofovir Disoproxil Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections

Abstract: Eur J Respir Med 2021, 3:3 238 European Journal of Respiratory Medicine 2021; 3(3): 238 - 248. doi: 10.31488/EJRM.122 Research article Clinical Features, Pathobiology, Efficacy, and Toxicity of Tenofovir Disoproxil Fumarate and Emtricitabine for Mild to Moderate SARSCoV-2 Infections E.A.G. Arruda≠1, R.J. Pires-Neto≠1, M.S. Medeiros1, J. Quirino-Filho2, M. Clementino2, R.N.D.G. Gondim2, L.M.V.C. Magalhães2, K.F. Cavalcante3, V.A.F. Viana3, L. P. Mello3, D.G.L. Lima1, A.A. Santos2, P.J.C. Magalhães2, A. Havt2, C.C. Clososki4, L.L.P. Silva4, N.P. Lopes4, E. Arruda5,6, A.A.M. Lima ≠*2,6 and study group members** 1.Hospital São José de Doenças Infecciosas (HSJ), Secretaria de Saúde do Ceará (SESA), Brazil 2.INCT-Biomedicina no Semiárido Brasileiro (INCT-Biomedicina), Núcleo de Biomedicina (NUBIMED), Faculdade de Medicina, UFC, Fortaleza, CE, Brazil 3.Secretaria de Vigilância em Saúde (SVS) e Laboratórios Central de Saúde Pública (LACEN), Brazil 4.Faculdade de Ciências Farmacêuticas de Ribeirão Preto USP, Ribeirão Preto, São Paulo, Brazil 5.Faculdade de Medicina, USP-RP, Ribeirão Preto, São Paulo, Brazil 6.Rede Vírus, Ministério da Ciência, Tecnologia, Inovações e Comunicações (MCTIC), Brasília-DF, Brazil * Corresponding author: Aldo AM Lima - Núcleo de Biomedicina, Faculdade de Medicina, Universidade Federal do Ceará. Rua Cel. Nunes de Melo, no. 1315, Rodolfo Teófilo, Fortaleza, CE, CEP 60430-270, Brazil; E-mail: alima@ufc.br E.A.G. Arruda, R.J. Pires-Neto and A.A.M. Lima contributed equally to this work. ≠ The complete list of members, including e-mail addresses and Institutions of the Antiretroviral Nucleotide Analogs Study Group in ** COVID-C19 (ARTAN-C19) has been provided at the end of the manuscript Received: October 11, 2021; Accepted: November 18, 2021; Published: November 22, 2021 Abstract This study evaluated the efficacy of tenofovir disoproxil fumarate (TDF) and TDF combined with emtricitabine (FTC) in patients with COVID-19 infections (ClinicalTrials.gov #NCT04712357). We conducted a randomized, double-blind, placebo-controlled clinical trial in patients with mild to moderate respiratory infection caused by SARS-CoV-2. Patients were randomly recruited to take 10 days of TDF (300 mg/day), TDF (300 mg/day) combined with FTC (200 mg/day) or placebo vitamin C (500 mg/day). From a total of 309 patients with clinical suspicion of SARS-CoV-2, 227 met the inclusion criteria and were randomly distributed into the following groups: (a) 75 (one did not initiate treatment) in the TDF; (b) 74 in the TDF combined with FTC; and (c) 77 in the vitamin C (placebo). Fever (≥37.8°C), ageusia or dysgeusia, anosmia or dysosmia, and two or more clinical signs and symptoms were significantly associated with SARS-CoV-2 infection. There was no significant change in clinical score based on clinical signs and symptoms between treatment groups. Patients with infection by SARS-CoV-2 had higher concentrations of G-CSF, IL-1β, IL-6 and TNF-α compared to patients without infection. In conclusions, patientswith fever (≥37.8°C), ageusia or dysgeusia, anosmia or dysosmia, and two or more signs and symptoms, had a better prediction for the diagnosis of COVID-19. In conclusions, patients with SARS-CoV-2 showed higher and more persistent proinflammatory cytokines and chemokines profile compared to patients not infected with SARS-CoV-2. Pharmacological intervention with TDF or TDF combined with FTC did not change the clinical signs and symptoms score..