Risk of hospitalization and sequelae in patients with COVID‐19 treated with 3‐day early remdesivir vs. controls in the vaccine and Omicron era: A real‐life cohort study

Abstract

Recently, a benefit from administration of a 3-day course of early remdesivir (ER) in the outpatients' setting was reported. However, real-life data on its use is scarce.Therefore, we explored the ER clinical outcome in our outpatients' s cohort, compared to untreated controls. We included all patients who were prescribed ER from February to May 2022 and followed them up for 3 months and compared patients who received treatment with untreated controls. In the two groups the following outcomes were investigated: hospitalization and mortality rate, time of negativization and symptom's resolution, and postacute coronavirus disease 19 (COVID-19) syndrome prevalence. Overall, 681 patients were analyzed, mostly females (53.6%), and with a median age of 66 years (interquartile range: 54-77), 316 (46.4%) patients received ER, and 365 (53.6%) did not receive antiviral treatment (control group). Overall, 8.5% patients eventually required oxygen support, 8.7% were hospitalized for COVID-19, and 1.5% died. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization and ER (adjusted odds ratio [aOR]: 0.049 [0.015; 0.16], p < 0.001) independently reduced hospitalization risk. ER was significantly associated with a shorter duration of SARS-CoV-2 positivity at nasopharyngeal swabs (aβ −8.15 [−9.21; −7.09], p < 0.001) and of symptoms (aβ −5.11 [−5.82; −4.39], p < 0.001), and with lower rate of COVID-19 sequelae compared to control group (aOR: 0.18 [0.10; 0.31], p < 0.001). Even in the SARS-CoV-2 vaccination and Omicron era, in patients at high risk of developing severe disease, ER demonstrated to have a good safety profile and to significantly reduce the risk of disease progression and COVID-19 sequelae compared to untreated controls.

The Evolution in Pharmacology of Infectious Diseases: 2022

“…These findings suggest that both azvudine and nirmatrelvir/ritonavir have an overall favorable safety profile for the treatment of COVID-19 patients, which aligns with the results of a recent meta-analysis involving 2,143 patients (Amani and Amani, 2023). From the incidence of adverse events perspective, our data, albeit limited, suggested an overall lower frequency of adverse events compared to clinical trials or other cohort studies (Gentile et al, 2022;Amani and Amani, 2023;Mazzitelli et al, 2023a;Cheema et al, 2023;Gao et al, 2023). For example, in a phase 2-3 doubleblind, randomized, controlled trial, the incidence of any adverse events during the treatment period was higher with nirmatrelvir/ Frontiers in Pharmacology frontiersin.org ritonavir compared to placebo (22.6% vs. 23.9%), while serious adverse events were 1.6% vs. 6.6% (Amani and Amani, 2023).…”

Effectiveness of Oral Nirmatrelvir/Ritonavir vs. Intravenous Three-Day Remdesivir in Preventing Progression to Severe COVID-19: A Single-Center, Prospective, Comparative, Real-Life Study

“…A comparison with an untreated control group would offer significant information. Mazzitelli et al, in Italy, compared 3RDV to no treatment in a large real-world cohort and found that the use of 3RDV would reduce the risk of hospitalization by 95% and the duration of positivity and symptoms by eight and five days, respectively [ 39 ]. Similarly, a recent observational study from Greece compared NMV/r to no treatment and showed that in the first group, only 1.5% required eventual hospitalization, compared to a staggering 55.5% in the control group [ 32 ].…”

Retrospective Analysis of the Outcome of Hospitalized COVID-19 Patients with Coexisting Metabolic Syndrome and HIV Using Multinomial Logistic Regression

“…Some antiviral treatment medications, such as ivermectin, which has recently received FDA approval, chloroquine, remdesivir, ribavirin, and lopinavir/ritonavir, among others, have been used to treat individuals who have SARS-CoV-2 infections. However, an effective and specific anti-SARS-CoV-2 drug is still to be identified [48] On the other hand, retrospective data from studies conducted in Italy show that early hospitalization and early use of remdesivir may reduce COVID-19 progression to more severe respiratory disease and provide clinical benefit in patients with COVID-19 [48][49][50].…”