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

Arruda et al., European Journal of Respiratory Medicine, doi:10.31488/EJRM.122, NCT04712357, Dec 2021
https://c19early.org/arruda.html
Hospitalization 80% improvement lower risk ← → higher risk Recovery -9% Tenofovir  Arruda et al.  EARLY TREATMENT RCT Is early treatment with Tenofovir beneficial for COVID-19? Double-blind RCT 84 patients in Brazil (November 2020 - July 2021) Lower hospitalization with Tenofovir (not stat. sig., p=0.24) c19early.org Arruda et al., European J. Respiratory.., Dec 2021 0 0.5 1 1.5 2+ RR
RCT 226 outpatients showing no significant difference with tenofovir disoproxil fumarate (TDF) alone or combined with emtricitabine (FTC) for mild to moderate COVID-19, compared with vitamin C.
risk of hospitalization, 80.4% lower, RR 0.20, p = 0.24, treatment 0 of 43 (0.0%), control 2 of 41 (4.9%), NNT 20, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of no recovery, 9.0% higher, RR 1.09, p = 0.82, treatment 16 of 43 (37.2%), control 14 of 41 (34.1%), day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Arruda et al., 31 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Brazil, peer-reviewed, 19 authors, study period 9 November, 2020 - 5 July, 2021, trial NCT04712357 (history). Contact: alima@ufc.br.
Clinical Features, Pathobiology, Efficacy, and Toxicity of Tenofovir Disoproxil Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections
E A G Arruda, R J Pires-Neto, M S Medeiros, J Quirino-Filho, M Clementino, R N D G Gondim, L M V C Magalhães, K F Cavalcante, V A F Viana, L P Mello, D G L Lima1, A A Santos, P J C Magalhães2, A Havt2, C C Clososki, L L P Silva, N P Lopes, A A M Lima, Aldo Am, R J Pires
European Journal of Respiratory Medicine, doi:10.31488/ejrm.122
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 assessed on the seventh day in patients with SARS-CoV-2. A graphical abstract is shown in Figure 1 .
Author Contributions
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DOI record: { "DOI": "10.31488/ejrm.122", "ISSN": [ "2633-7452" ], "URL": "http://dx.doi.org/10.31488/EJRM.122", "container-title": "European Journal of Respiratory Medicine", "container-title-short": "Eur J Respir Med", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2022, 11, 21 ] ], "date-time": "2022-11-21T19:43:17Z", "timestamp": 1669059797000 }, "deposited": { "date-parts": [ [ 2022, 11, 21 ] ], "date-time": "2022-11-21T19:43:18Z", "timestamp": 1669059798000 }, "indexed": { "date-parts": [ [ 2022, 11, 22 ] ], "date-time": "2022-11-22T06:02:08Z", "timestamp": 1669096928917 }, "is-referenced-by-count": 0, "issue": "3", "issued": { "date-parts": [ [ 2021 ] ] }, "journal-issue": { "issue": "3", "published-online": { "date-parts": [ [ 2021 ] ] } }, "member": "16388", "original-title": [], "prefix": "10.31488", "published": { "date-parts": [ [ 2021 ] ] }, "published-online": { "date-parts": [ [ 2021 ] ] }, "publisher": "MAK Periodical Library", "reference-count": 0, "references-count": 0, "relation": {}, "resource": { "primary": { "URL": "https://europeanjournalofrespiratorymedicine.com/clinical-features-pathobiology-efficacy-and-toxicity-of-tenofovir-disoproxil-fumarate-and-emtricitabine-for-mild-to-moderate-sars-coV-2-infections" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "title": "Clinical Features, Pathobiology, Efficacy, and Toxicity of Tenofovir Disoproxil Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections", "type": "journal-article", "volume": "3" }
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