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Effect of Tenofovir Alafenamide Fumarate on the outcomes of hospitalized COVID-19 patients: a prospective, block-balanced, open-label, randomized controlled trial

Yazdan Pouri et al., BMC Pharmacology and Toxicology, doi:10.1186/s40360-024-00781-3, IRCT20200422047168N1, Oct 2024
https://c19early.org/yazdanpouri.html
Ventilation 89% Improvement Relative Risk ICU admission 25% Tenofovir  Yazdan Pouri et al.  LATE TREATMENT  RCT Is late treatment with Tenofovir beneficial for COVID-19? RCT 60 patients in Iran (September 2020 - February 2021) Lower ventilation with Tenofovir (not stat. sig., p=0.11) c19early.org Yazdan Pouri et al., BMC Pharmacology .., Oct 2024 FavorsTenofovir Favorscontrol 0 0.5 1 1.5 2+
RCT 60 hospitalized COVID-19 patients showing fewer mechanical ventilation and ICU days with tenofovir alafenamide fumarate (TAF) treatment in addition to remdesivir and corticosteroids.
risk of mechanical ventilation, 88.9% lower, RR 0.11, p = 0.11, treatment 0 of 30 (0.0%), control 4 of 30 (13.3%), NNT 7.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of ICU admission, 25.0% lower, RR 0.75, p = 1.00, treatment 3 of 30 (10.0%), control 4 of 30 (13.3%), NNT 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Yazdan Pouri et al., 17 Oct 2024, Randomized Controlled Trial, Iran, peer-reviewed, 7 authors, study period September 2020 - February 2021, trial IRCT20200422047168N1. Contact: zahrashokati@gmail.com, shayeste-a@ajums.ac.ir.
Effect of Tenofovir Alafenamide Fumarate on the outcomes of hospitalized COVID-19 patients: a prospective, block-balanced, open-label, randomized controlled trial
Nazanin Yazdan Pouri, Zahra Shokati Eshkiki, Afshin Talebi, Bahman Cheraghian, Fatemeh Ahmadi, Niloofar Neisi, Ali Akbar Shayesteh
BMC Pharmacology and Toxicology, doi:10.1186/s40360-024-00781-3
Background The global effort to cure COVID-19 is still ongoing. Thus, a prospective, block-balanced, open-label, randomized controlled trial was conducted to evaluate how Tenofovir Alafenamide Fumarate affects hospitalized COVID-19 patients' outcomes. Methods The intervention and control groups of 60 hospitalized COVID-19 patients were randomly allocated. Along with normal medication, the intervention group received 25 mg of tenofovir orally daily for seven days. The control group got normal therapy, including remdesivir and corticosteroids. ICU hospitalization duration, laboratory data, fever, dyspnea, arterial blood oxygen saturation with and without an oxygen face mask, mechanical ventilation, and mortality were the outcomes. Results Sixty of 236 eligible patients between September 2020 and February 2021 were enrolled. The intervention group had a mean age (±SD) of 61.33 (±13.09) years and the control group 60.03 (±18.03). Sixteen (53.3%) intervention patients and 15 (50.0%) control patients were males. The intervention group had fewer mechanical ventilation and ICU days. Tenofovir Alafenamide Fumarate did not improve fever, dyspnea, oxygen saturation with or without a face mask or nasal cannula, or laboratory data including WBC, ESR, CRP, AST, ALT, AlkP, total and direct bilirubin, in COVID-19 patients. Conclusion According to this pilot trial, Tenofovir Alafenamide Fumarate, along with conventional treatment, significantly reduced mechanical ventilation and ICU stay in COVID-19 patients. Further thorough research is necessary to verify this conclusion.
Author contributions N.Y.P. conceived and designed the study. A.T. and F.A. and N.N. performed the intervention and participated in clinical follow-up of the patients. B.C. analyzed and interpreted the data. Z.S.E. and A.A.S. wrote the main manuscript text and managed the study. All authors approved the final version. Declarations Ethics approval and informed consent This study received ethical approval in 29/04/2020 (IR.AJUMS.REC.1399.082) from the Ahvaz-Jundishapur University of Medical Sciences in Ahvaz, Iran. The protocol was made available on the website WWW.IRCT.ir with the identification IRCT20200422047168N1. Written informed consent was obtained from all the participants, and the study was carried out following the guidelines of the Declaration of Helsinki. Competing interests The authors declare no competing interests. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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GS-7340 demonstrates greater declines in HIV-1 RNA than tenofovir disoproxil fumarate during 14 days of monotherapy in HIV-1 infected subjects. 18th Conference on Retroviruses and Opportunistic Infections; 2011." }, { "author": "WJ Guan", "first-page": "1861", "issue": "19", "journal-title": "N Engl J Med", "key": "781_CR24", "unstructured": "Guan WJ, Zhong NS. Clinical characteristics of Covid-19 in China. Reply. N Engl J Med. 2020;382(19):1861–2.", "volume": "382", "year": "2020" }, { "DOI": "10.23736/S0375-9393.20.15195-2", "author": "L Peluso", "doi-asserted-by": "publisher", "first-page": "1", "issue": "1", "journal-title": "Minerva Anestesiol", "key": "781_CR25", "unstructured": "Peluso L, Abella BS, Ferrer R, Kucher N, Sunde K, Taccone FS. Fever management in COVID-19 patients. Minerva Anestesiol. 2021;87(1):1–3.", "volume": "87", "year": "2021" }, { "DOI": "10.3389/fped.2021.736013", "author": "Z Shokati Eshkiki", "doi-asserted-by": "publisher", "first-page": "736013", "journal-title": "Front Pediatr", "key": "781_CR26", "unstructured": "Shokati Eshkiki Z, Shahriari A, Seyedtabib M, Torabizadeh M, Assarehzadegan MA, Nashibi R, Khosravi M, Neisi N, Mard SA, Shayesteh AA. Innate and adaptive immunity imbalance with severe COVID-19 pneumonia in children and adults. Front Pediatr. 2021;9:736013.", "volume": "9", "year": "2021" }, { "DOI": "10.1111/acem.14052", "author": "RM Levitan", "doi-asserted-by": "publisher", "first-page": "785", "issue": "8", "journal-title": "Acad Emerg Med", "key": "781_CR27", "unstructured": "Levitan RM. Pulse oximetry as a biomarker for early identification and hospitalization of COVID-19 pneumonia. Acad Emerg Med. 2020;27(8):785.", "volume": "27", "year": "2020" }, { "key": "781_CR28", "unstructured": "Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, evaluation, and treatment of coronavirus (COVID-19). Statpearls [internet]. 2022." }, { "DOI": "10.1111/hiv.13228", "author": "CS Kow", "doi-asserted-by": "publisher", "first-page": "807", "issue": "7", "journal-title": "HIV Med", "key": "781_CR29", "unstructured": "Kow CS, Ramachandram DS, Hasan SS. The use of tenofovir in patients with COVID-19. HIV Med. 2022;23(7):807–8.", "volume": "23", "year": "2022" }, { "DOI": "10.1007/s10620-022-07817-w", "doi-asserted-by": "crossref", "key": "781_CR30", "unstructured": "Mateos-Muñoz B, Buti M, Vázquez IF, Conde MH, Bernal-Monterde V, Díaz-Fontenla F, et al. Tenofovir disoproxil fumarate reduces the severity of COVID-19 in patients with chronic hepatitis B. Dig Dis Sci. 2023:1–7." }, { "DOI": "10.1016/j.cmi.2022.07.006", "author": "R Polo", "doi-asserted-by": "publisher", "first-page": "85", "issue": "1", "journal-title": "Clin Microbiol Infect", "key": "781_CR31", "unstructured": "Polo R, García-Albéniz X, Terán C, Morales M, Rial-Crestelo D, Garcinuño MA, et al. Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo-controlled randomized trial in healthcare workers. Clin Microbiol Infect. 2023;29(1):85–93.", "volume": "29", "year": "2023" }, { "key": "781_CR32", "unstructured": "Painter WP, Sheahan T, Baric R, Holman W, Donovan J, Fang L, et al. Reduction in infectious SARS-CoV-2 in treatment study of COVID-19 with molnupiravir. Top Antivir Med. 2021:304–5." }, { "DOI": "10.1097/QAD.0000000000002877", "author": "C DeJong", "doi-asserted-by": "publisher", "first-page": "1509", "issue": "9", "journal-title": "AIDS", "key": "781_CR33", "unstructured": "DeJong C, Spinelli MA, Okochi H, Gandhi M. Tenofovir-based PrEP for COVID-19: an untapped opportunity? AIDS. 2021;35(9):1509.", "volume": "35", "year": "2021" }, { "DOI": "10.1093/aje/kwab109", "author": "S Hernandez-Diaz", "doi-asserted-by": "publisher", "first-page": "2339", "issue": "11", "journal-title": "Am J Epidemiol", "key": "781_CR34", "unstructured": "Hernandez-Diaz S, Bateman BT, Straub L, Zhu Y, Mogun H, Fischer M, et al. Safety of tenofovir disoproxil fumarate for pregnant women facing the coronavirus disease 2019 pandemic. Am J Epidemiol. 2021;190(11):2339–49.", "volume": "190", "year": "2021" } ], "reference-count": 34, "references-count": 34, "relation": {}, "resource": { "primary": { "URL": "https://bmcpharmacoltoxicol.biomedcentral.com/articles/10.1186/s40360-024-00781-3" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "title": "Effect of Tenofovir Alafenamide Fumarate on the outcomes of hospitalized COVID-19 patients: a prospective, block-balanced, open-label, randomized controlled trial", "type": "journal-article", "update-policy": "http://dx.doi.org/10.1007/springer_crossmark_policy", "volume": "25" }
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.
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