J Med Virol . Efficacy and safety of favipiravir plus interferon-beta versus lopinavir/ritonavir plus interferon-beta in moderately ill patients with covid-19: a randomized clinical trial

[tetano]

J Med Virol


. 2022 Mar 16.
doi: 10.1002/jmv.27724. Online ahead of print.
Efficacy and safety of favipiravir plus interferon-beta versus lopinavir/ritonavir plus interferon-beta in moderately ill patients with covid-19: a randomized clinical trial


Mehdi Hassaniazad ¹ , Hossein Farshidi ² , Abdollah Gharibzadeh ³ , Ali Bazram ¹ , Elham Khalili ⁴ , Afsaneh Noormandi ⁵ , Mohammad Fathalipour ^{6 7}



Affiliations

• PMID: 35292989
• DOI: 10.1002/jmv.27724

Abstract

Background: Favipiravir (FVP), Lopinavir/Ritonavir (LPV/RTV), and Interferon-beta (INF-beta) are considered as potential treatments for COVID-19. We examined the efficacy and safety of FVP and INF-beta compared to LPV/RTV and INF-beta combinations for the treatment of SARS-CoV-2. It was a single-center randomized clinical trial.
Methods: Eligible patients were randomized to receive FVP plus INF-beta versus LPV/RTV plus INF-beta. The primary endpoint was the viral clearance after seven days of randomization. ICU admission, length of stay (LOS) in hospital, in-hospital mortality, and the incidence of adverse events were also measured. This trial was registered on the Iranian Registry of Clinical Trials (IRCT20200506047323N3).
Results: Patients were randomly allocated to the FVP (n=33) and LPV/RTV (n=33) groups. The viral clearance on day seven was not significantly different between the FVP (31.1%) and the LPV/RTV group (16.1%). The rate of ICU admission and likewise the in-hospital mortality in the FVP group (12.5% and 6.3%, respectively) were similar to the LPV/RTV groups (19.4% and 19.4%, respectively). Median LOS in the hospital was also not different (6.8 days [IQR=5.0-11.0] in the FVP and (8.0 days [IQR=5.5-12.5]) in LPV/RTV groups (p=0.140). Adverse events were observed in 25.0% of FVP and 32.3% of LPV/RTV groups.
Conclusion: The combination therapy with FVP did not exert a higher efficacy compared to the combination regimen of LPV/RTV. However, both treatment regimens demonstrated a mild profile of adverse events. This article is protected by copyright. All rights reserved.

Keywords: Antiviral agents; Interferon; SARS-coronavirus.