Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study

Mazzitelli, Maria; Mengato, Daniele; Sasset, Lolita; Ferrari, Anna; Gardin, Samuele; Scaglione, Vincenzo; Bonadiman, Nicola; Calandrino, Lucrezia; Cavinato, Silvia; Trivellato, Sabrina; Venturini, Francesca; Cattelan, Anna María

doi:10.3390/v15020384

Cited by 28 publications

(24 citation statements)

References 18 publications

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“…Our experience of oral antiviral in the early treatment of COVID-19 is available elsewhere. 33 Remdesivir was administered intravenously in the outpatient's clinic at the dosage of 200 mg the first day, followed by 100 mg/daily for other 2 days.…”

Section: Methodsmentioning

confidence: 99%

“…Patients who received a concomitant treatment with oral antiviral agents nirmatrelvir/ritonavir or molnupiravir, or monoclonal antibodies were excluded, since our aim was to assess the outcome for the early antiviral intravenous option. Our experience of oral antiviral in the early treatment of COVID‐19 is available elsewhere 33 . Remdesivir was administered intravenously in the outpatient's clinic at the dosage of 200 mg the first day, followed by 100 mg/daily for other 2 days.…”

Section: Methodsmentioning

confidence: 99%

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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

Mazzitelli

Trunfio

Sasset

et al. 2023

Journal of Medical Virology

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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

Mazzitelli

Trunfio

Sasset

et al. 2023

Journal of Medical Virology

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“…Four studies 19,28,29,31 involving 1679 patients reported the incidence of adverse events leading to treatment discontinuation. The pooled estimate showed no significant difference between the two treatment groups in terms of incidence of adverse events leading to treatment discontinuation (OR = 1.18, 95% CI: 0.69–2.00, p = 0.53, I 2 = 10.15%) (Figure 3B).…”

Section: Resultsmentioning

confidence: 99%

“…Four studies 19,28,29,31 involving 1679 patients reported the incidence of adverse events leading to treatment discontinuation.…”

Section: Adverse Events Leading To Treatment Discontinuationmentioning

confidence: 99%

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Comparative efficacy and safety of nirmatrelvir/ritonavir and molnupiravir for COVID‐19: A systematic review and meta‐analysis

Amani

Akbarzadeh

Amani

et al. 2023

Journal of Medical Virology

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This study aimed to compare the efficacy and safety of nirmatrelvir/ritonavir (Paxlovid) with molnupiravir in the treatment of coronavirus disease 2019 . To end this, PubMed, Cochrane Library, Web of Science, medRxiv, and Google Scholar were systematically searched to collect relevant evidence up to February 15, 2023. The risk of bias was evaluated using the risk of bias in nonrandomized studies of interventions tool. Data were analyzed using Comprehensive Meta-Analysis software. Eighteen studies involving 57 659 patients were included in the meta-analysis. The meta-analysis showed a significant difference between nirmatrelvir/ritonavir and molnupiravir in terms of all-cause mortality rate (odds ratio [OR] = 0.54, 95% confidence interval [CI]: 0.44-0.67), all-cause hospitalization rate (OR = 0.61, 95% CI: 0.54-0.69), death or hospitalization rate (OR = 0.61, 95% CI: 0.38-0.99), and negative polymerase chain reaction conversion time (mean difference = −1.55, 95% CI: −1.74 to −1.37). However, no significant difference was observed between the two groups in terms of COVID-19 rebound (OR = 0.87, 95% CI: 0.71-1.07). In terms of safety, although the incidence of any adverse events was higher in the nirmatrelvir/ritonavir group (OR = 2.52, 95% CI:1.57-4.06), no significant difference was observed between the two treatments in terms of adverse events leading to treatment discontinuation (OR = 1.18, 95% CI: 0.69-2.00). The present meta-analysis demonstrated the significant superiority of nirmatrelvir/ritonavir over molnupiravir in improving clinical efficacy in COVID-19 patients during the prevalence of Omicron variant. These findings, however, need to be further confirmed.

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Dissecting the Interrelationship between COVID‐19 and Diabetes Mellitus

2023

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COVID‐19 disease, caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), has led to enormous morbidity and mortality worldwide. After gaining entry into the human host, the virus initially infects the upper and lower respiratory tract, subsequently invading multiple organs, including the pancreas. While on one hand, diabetes mellitus (DM) is a significant risk factor for severe COVID‐19 infection and associated death, recent reports have shown the onset of DM in COVID‐19‐recovered patients. SARS‐CoV‐2 infiltrates the pancreatic islets and activates stress response and inflammatory signaling pathways, impairs glucose metabolism, and consequently leads to their death. Indeed, the pancreatic autopsy samples of COVID‐19 patients reveal the presence of SARS‐CoV‐2 particles in β‐cells. The current review describes how the virus enters the host cells and activates an immunological response. Further, it takes a closer look into the interrelationship between COVID‐19 and DM with the aim to provide mechanistic insights into the process by which SARS‐CoV‐2 infects the pancreas and mediates dysfunction and death of endocrine islets. The effects of known anti‐diabetic interventions for COVID‐19 management are also discussed. The application of mesenchymal stem cells (MSCs) as a future therapy for pancreatic β‐cells damage to reverse COVID‐19‐induced DM is also emphasized.

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Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study

Cited by 28 publications

References 18 publications

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

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

Comparative efficacy and safety of nirmatrelvir/ritonavir and molnupiravir for COVID‐19: A systematic review and meta‐analysis

Dissecting the Interrelationship between COVID‐19 and Diabetes Mellitus

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