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The efficacy and adverse effects of favipiravir on COVID-19 patients: a systematic review and meta-analysis of published clinical trials and observational studies

Hung et al., SSRN, doi:10.2139/ssrn.3889346
Apr 2022  
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Systematic review and meta analysis of 17 favipiravir trials, showing improved viral clearance and recovery.
Currently there are 68 favipiravir studies and meta analysis shows:
OutcomeImprovement
Mortality12% lower [-4‑26%]
Ventilation10% higher [-23‑56%]
ICU admission31% higher [9‑56%]
Hospitalization4% higher [-13‑23%]
Hung et al., 22 Apr 2022, peer-reviewed, 23 authors.
This PaperFavipiravirAll
The efficacy and adverse effects of favipiravir on patients with COVID-19: A systematic review and meta-analysis of published clinical trials and observational studies
Dang The Hung, Suhaib Ghula, Jeza Muhamad Abdul Aziz, Abdelrahman M Makram, Gehad Mohamed Tawfik, Ali Ahmed-Fouad Abozaid, Rohan Andrew Pancharatnam, Amr Mohamed Ibrahim, Muhammad Besher Shabouk, Morgan Turnage, Saloni Nakhare, Zahra Karmally, Basel Kouz, Tran Nhat Le, Suleiman Alhijazeen, Nguyen Quoc Phuong, Alaa Mohamed Ads, Ali Hussein Abdelaal, Nguyen Hai Nam, Tatsuo Iiyama, Kyoshi Kita, Kenji Hirayama, Nguyen Tien Huy
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.04.035
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Ethical Approval: This study is exempt from ethical approval. Conflict of interest We declare no competing interests.
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Observational, cross-sectional studies and ' 'case series were assessed 197 using the National Institutes of Health ' 'quality assessment tool 29 . Case reports were assessed as 198 ' 'recommended by the Clinical Guidelines Network Cancer Council Australia ' '(CCA) handbook 30'}, { 'key': 'ref4', 'journal-title': 'The study selection, data extraction, and quality assessment'}, { 'key': 'ref5', 'journal-title': 'The funder of the study had no role in study design, data collection'}, { 'key': 'ref6', 'volume': '3861', 'year': '2020', 'journal-title': 'papers, respectively. A total of 142 publications passed the screening ' 'and entered the extraction 209 stage. Additional three RCTs were found ' 'in manual searches. Eventually, 15 RCTs, one non-RCT, 210 21 ' 'observational studies, two case series'}, { 'key': 'ref7', 'first-page': '31', 'volume': '11', 'journal-title': 'Meta-analysis for the effectiveness of favipiravir 10'}, {'key': 'ref8', 'journal-title': 'This preprint research paper has not been peer reviewed'}, { 'key': 'ref9', 'first-page': '38', 'volume': '11', 'journal-title': 'we plotted RR for the number of patients having the viral 216 clearance ' "from day 3 to day 16, using Musekiwa et al.'s univariate and " 'multivariate model 24'}, { 'key': 'ref10', 'journal-title': 'In multivariate model, 218 although all RR values were greater than ' 'one, significant better outcomes were found only at day 219 4-6 with a ' 'peak value'}, { 'key': 'ref11', 'journal-title': 'Despite insignificance, mean viral clearance time was shorter in ' 'patients received favipiravir 225 (MD=-1�52, 95% CI [-5�03, 1�99], ' 'p=0�30, I 2 =81%) (Supplemental Figure 3a). However, in the 226 ' 'sensitivity analysis, the heterogeneity plummeted (I 2 =0%), making the ' 'difference statistically 227 significant'}, { 'key': 'ref12', 'article-title': 'On the 232 other hand, the pooled RR from four papers for defervescence ' 'at day 3 was significantly better in 233 the favipiravir group ' '(RR=1�91, 95% CI [1�56, 2�34], p<0�01, I 2 =0%) (Figure 3b)', 'journal-title': 'Clinical improvement, fever cessation, and chest CT improvement for ' 'favipiravir 10,11,34,42 , the pooled RR from five RCTs was not ' 'statistically significant 231 (RR=1�54, 95% CI'}, { 'key': 'ref13', 'author': 'World Health', 'journal-title': "WHO Director-General's opening remarks at the mission briefing on 423 " 'COVID-19'}, {'key': 'ref14', 'author': 'W Zhu', 'journal-title': 'RNA-Dependent RNA'}, { 'issue': '10', 'key': 'ref15', 'doi-asserted-by': 'publisher', 'first-page': '1141', 'DOI': '10.1177/2472555220942123', 'article-title': 'Polymerase as a Target for COVID-19 Drug Discovery', 'volume': '25', 'year': '2020', 'journal-title': 'SLAS Discov'}, { 'key': 'ref16', 'author': 'M Gandhi', 'journal-title': "Asymptomatic Transmission, the Achilles' Heel of"}, { 'key': 'ref17', 'first-page': '36', 'volume': '2020', 'journal-title': 'Current Strategies to Control COVID-19. 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'journal-title': 'BMC 866 Infect Dis'}, { 'issue': '1', 'key': 'ref203', 'doi-asserted-by': 'publisher', 'first-page': '177', 'DOI': '10.1148/radiol.2021203153', 'article-title': 'Six-month Follow-up Chest CT Findings after Severe 868 COVID-19 ' 'Pneumonia', 'volume': '299', 'author': 'X Han', 'year': '2021', 'journal-title': 'Radiology'}, { 'key': 'ref204', 'doi-asserted-by': 'publisher', 'author': 'A Goyal', 'journal-title': 'Potency and timing of antiviral therapy as 870 determinants of duration ' 'of SARS-CoV-2 shedding and intensity of inflammatory response', 'DOI': '10.1101/2020.04.10.20061325'}, { 'issue': '47', 'key': 'ref205', 'doi-asserted-by': 'publisher', 'volume': '6', 'year': '2020', 'journal-title': 'Science advances', 'DOI': '10.1680/jadcr.2021.33.1.47'}, { 'issue': '11', 'key': 'ref206', 'article-title': 'The risks of liver injury in COVID-19 875 patients and pharmacological ' 'management to reduce or prevent the damage induced', 'volume': '15', 'author': 'S Kaneko', 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Multivariate and ' 'univariate meta-analysis for the effect of favipiravir on viral ' 'clearance 906 rate at different timepoints (a) and two detailed forest ' 'plots for the univariate analysis at day 5 (b) 907 and day', 'volume': '1', 'journal-title': 'Table 1. Patient characteristics of included RCTs and non-RCTs.Figure'}, { 'key': 'ref219', 'volume': '3', 'journal-title': 'Meta-analysis for the effect of favipiravir on the rate of patients ' 'having clinical 909 improvement at day 10 (a), defervescence at day 3 ' '(b) and CT improvement at day 14-15 (c)'}, { 'key': 'ref220', 'volume': '4', 'journal-title': 'Meta-analysis for the effect of favipiravir on the risk of ' 'hyperuricemia (a), increased 911 alanine aminotransferase (b), ' 'increased aspartate aminotransferase (c), nausea (d), and vomiting'}, {'key': 'ref221', 'journal-title': 'Supplemental Table legend'}, { 'key': 'ref222', 'journal-title': 'Supplemental Table 2. Databases searched, search terms, and the results ' 'in the searches'}, { 'key': 'ref223', 'first-page': '3', 'journal-title': 'Supplemental Table 3. Detailed results for different meta-analysis ' 'models of RR for viral clearance 917 rate at days'}, { 'key': 'ref224', 'journal-title': 'Definition for clinical improvement, defervescence and chest CT 919 ' 'improvement for papers that entered meta-analysis'}, { 'key': 'ref225', 'journal-title': 'Baseline characteristics and outcomes of included observational studies ' 'and 921 case series'}, { 'key': 'ref226', 'journal-title': 'Supplemental Table 6. Quality review for favipiravir adverse events ' 'from observational studies'}, { 'key': 'ref227', 'journal-title': 'Supplemental Table 8. QA results for RCT using ROB2 from Cochrane'}, { 'key': 'ref228', 'journal-title': 'This preprint research paper has not been peer reviewed'}, { 'key': 'ref229', 'journal-title': "Supplemental Table 10. QA results using NIH's tool for Observational " 'Cohort and Cross-Sectional'}, { 'key': 'ref230', 'article-title': 'Meta-analysis for the effect of favipiravir on mean viral clearance ' '(a), 937 clinical improvement time (c), defervescence time (e) and ' 'sensitivity analyses by removing studies 938 comparing favipiravir ' 'versus any antiviral drugs for the first two (b) (d)', 'volume': '3', 'journal-title': 'Supplemental Figure'}, { 'key': 'ref231', 'journal-title': 'Meta-analysis for the discharge rate at day 10-11 (a), day 14-15 (b), ' 'mean 940 difference in length of hospital stay (c) and its sensitivity ' 'analysis (d)'}, { 'key': 'ref232', 'journal-title': 'Supplemental Figure 5. Meta-analysis for the effect of favipiravir on ' 'mortality for all trials (a), its'}, { 'key': 'ref233', 'journal-title': 'This preprint research paper has not been peer reviewed'}], 'container-title': ['SSRN Electronic Journal'], 'original-title': [], 'language': 'en', 'deposited': { 'date-parts': [[2021, 7, 21]], 'date-time': '2021-07-21T15:39:48Z', 'timestamp': 1626881988000}, 'score': 1, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021]]}, 'references-count': 233, 'URL': 'http://dx.doi.org/10.2139/ssrn.3889346', 'relation': {}, 'ISSN': ['1556-5068'], 'issn-type': [{'value': '1556-5068', 'type': 'electronic'}], 'published-other': {'date-parts': [[2021]]}, 'published': {'date-parts': [[2021]]}}
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