Favipiravir Effectiveness and Safety in Hospitalized Moderate-Severe COVID-19 Patients: Observational Prospective Multicenter Investigation in Saudi Arabia.

Saleh Al-Muhsen,Nouf S Al-Numair,Fahad Alsohime,Amjad Jabaan,Roaa Basamh,Haya Al-Saud,Banan Alyounes,Mohammed F Alosaimi,Narjes Saheb Sharif-Askari,Fatemeh Saheb Sharif-Askari,Rabih Halwani

doi:10.3389/fmed.2022.826247

Abstract

ObjectivesThere are limited data on the efficacy and safety of favipiravir antiviral in coronavirus disease 2019 (COVID-19), particularly in the more progressed disease phase. This study aims to evaluate the favipiravir effect on reducing the length of hospital stay and in-hospital mortality among moderate and severe hospitalized COVID-19 patients.MethodsA prospective, multicenter observational study was conducted that included moderate and severe hospitalized adult COVID-19 patients in four major regions (Riyadh (Riyadh), Eastern (Dammam), Al-Qassem (Buraydah), and Macca (Jeddah) of Saudi Arabia. For the primary outcome of all-cause mortality, a Cox proportional hazard analysis was performed. While the association between favipiravir use and length of hospital stay was determined using adjusted generalized linear model. This study was approved by the Central Institutional Review Board in The Saudi Ministry of Health (MoH) with the approval number IRB # 20-85-M.ResultsThis study included 598 moderate and severe COVID-19 patients, of whom 156 (26%) received favipiravir. Favipiravir treatment was associated with more extended hospital stays (14 vs. 10 median days, P = 0.034) and higher mortality rate (aHR 3.63; 95% CI 1.06–12.45) compared to no favipiravir regimen. Despite lack of effectiveness, favipiravir use was only associated with higher diarrhea adverse effects (12 vs. 5%, P = 0.002), but it did not affect the renal and liver profiles of patients.ConclusionFavipiravir was ineffective in reducing the length of hospital stay and in-hospital mortality in patients with moderate and severe COVID-19.

Highlights

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of coronavirus disease 2019 (COVID-19), which has urged for development of novel therapeutics and repurposing of existing drugs
This study aims to evaluate the favipiravir effect on reducing the length of hospital stay and in-hospital mortality among moderate and severe hospitalized COVID-19 patients
Favipiravir treatment was associated with more extended hospital stays (14 vs. 10 median days, P = 0.034) and higher mortality rate compared to no favipiravir regimen

Summary

Introduction

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of coronavirus disease 2019 (COVID-19), which has urged for development of novel therapeutics and repurposing of existing drugs. Since the start of the pandemic, national and global protocols for COVID-19 treatment have kept evolving with the continuous flow of new scientific evidence and research data. Favipiravir is an example of an oral antiviral drug repurposed for COVID-19 management [1]. It inhibits the RNA-dependent RNA polymerase (RdRp) of RNA viruses, preventing viral genome replication. Besides COVID-19, this investigational antiviral has been considered to manage other viral outbreaks such as Ebola [3] and the Lassa virus [4]

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