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Effectiveness and safety of favipiravir compared to supportive care in moderately to critically ill COVID-19 patients: a retrospective study with propensity score matching sensitivity analysis

Alamer et al., Current Medical Research and Opinion, doi:10.1080/03007995.2021.1920900
May 2021  
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Mortality -56% Improvement Relative Risk Ventilation 90% Adjusted discharge ratio 49% Favipiravir  Alamer et al.  LATE TREATMENT Is late treatment with favipiravir beneficial for COVID-19? Retrospective 456 patients in Saudi Arabia Lower ventilation (p<0.0001) and higher discharge (p<0.0001) c19early.org Alamer et al., Current Medical Researc.., May 2021 Favorsfavipiravir Favorscontrol 0 0.5 1 1.5 2+
Retrospective 234 favipiravir and 223 control patients in Saudi Arabia, showing shorter time to discharge and lower progression to ventilation, but no significant difference in mortality.
risk of death, 56.0% higher, HR 1.56, p = 0.26, treatment 12 of 233 (5.2%), control 21 of 223 (9.4%), adjusted per study, day 90.
risk of mechanical ventilation, 90.0% lower, HR 0.10, p < 0.001, treatment 4 of 218 (1.8%), control 27 of 165 (16.4%), NNT 6.9, adjusted per study.
adjusted discharge ratio, 49.0% lower, RR 0.51, p < 0.001, treatment 221, control 201, adjusted per study, inverted to make RR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Alamer et al., 19 May 2021, retrospective, Saudi Arabia, peer-reviewed, 18 authors.
This PaperFavipiravirAll
Effectiveness and safety of favipiravir compared to supportive care in moderately to critically ill COVID-19 patients: a retrospective study with propensity score matching sensitivity analysis
Ahmad Alamer, Ahmed A Alrashed, Mashael Alfaifi, Bandar Alosaimi, Fatimah Alhassar, Malak Almutairi, Jude Howaidi, Wedad Almutairi, Yahya Mohzari, Tarek Sulaiman, Ahmed Al-Jedai, Hamdan N Alajami, Fatima Alkharji, Ali Alsaeed, Alaa H Alali, Abdullah A Baredhwan, Ivo Abraham, Abdulaziz S Almulhim
Current Medical Research and Opinion, doi:10.1080/03007995.2021.1920900
Introduction: Favipiravir is a repurposed drug to treat coronavirus 2019 (COVID-19). Due to a lack of available real-world data, we assessed its effectiveness and safety in moderately to critically ill COVID-19 patients. Methods: This retrospective study was conducted in two public/specialty hospitals in Saudi Arabia. We included patients !18 years) admitted April-August 2020 with confirmed SARS-CoV-2 diagnosed by real-time polymerase chain reaction (RT-PCR) from nasopharyngeal swab. Patients received either favipiravir (1800 mg or 1600 mg twice daily loading dose, followed by 800 mg or 600 mg twice daily) or supportive-care treatment. Patients were excluded if they were outside the study period, classified as having a mild form of the disease per WHO criteria, or had an incomplete patient file. Kaplan-Meier (KM) models were used to estimate median time to discharge. Discharge ratios, progression to mechanical ventilation, and mortality outcomes were estimated across the severity spectrum using Cox proportional-hazards models. As a sensitivity analysis, we performed propensity score-matching (PSM) analysis. Results: Overall, median time to discharge was 10 days (95%CI ¼ 9-10) in the favipiravir arm versus 15 days (95%CI ¼ 14-16) in the supportive-care arm. The accelerated discharge benefit was seen across the COVID-19 spectrum of severity. The adjusted discharge ratio was 1.96 (95%CI ¼ 1.56-2.46). Progression to mechanical ventilation was slower with favipiravir (HR adj ¼ 0.10, 95%CI ¼ 0.04-0.29). There was no significant effect on mortality (HR adj ¼ 1.56, 95%CI ¼ 0.73-3.36). There was a statistically non-significant trend toward worse outcomes in the critical category (HR adj ¼ 2.80, 95%CI ¼ 0.99-7.89). Age was an independent risk factor for mortality in mechanically ventilated patients. PSM analyses confirmed these findings. Conclusion: Favipiravir was associated with clinical benefits, including accelerated discharge rate and less progression to mechanical ventilation; however, no overall mortality benefits were seen across the severity spectrum.
Author contributions Conceptualization: Ahmad Alamer and Ahmad A Alrashed; methodology: Ahmad Alamer and Ivo Abraham; software: Ahmad Alamer; validation: Abdulaziz S. Alulhmim and Ivo Abraham; formal analysis: Ahmad Alamer; data curation: Fatima Alhassar, Malak M. Almutairi, Jude Howaidi, Wedad Almutairi, and Mashael Alfaifi; writing of original draft preparation: Ahmad Alamer and Abdulaziz S. Alulhmim; writing, reviewing, and editing: Ahmad Alamer, Abdulaziz S. Alulhmim, Ivo Abraham, Ahmad A Alrashed, Bandar Alosaimi, Yahya Mohzari, Tarek Sulaiman, Ahmed AlJedai, Alaa H. Alali, and Abdulla Baradwan; visualization: Ahmad Alamer; supervision: Ahmad Alamer and Ivo Abraham; project administration: Ahmad Alamer, Mashael Alfaifi, Ahmad A Alrashed, and Yahya Mohzari. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, declare their responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
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Late treatment
is less effective
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