Efficacy and safety of oral antivirals in individuals aged 80 years or older with mild-to-moderate COVID-19: preliminary report from an Italian Prescriber Center

Bruno, Giuseppe; Perelli, Serena; Giotta, Massimo; Bartolomeo, Nicola; Vita, Giuseppina De; Buccoliero, Giovanni Battista

doi:10.53854/liim-3004-9

Cited by 3 publications

(3 citation statements)

References 16 publications

(19 reference statements)

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“…Most of the published literature on the efficacy of NMV-r and MOV has focused on the whole population [ 5 , 6 , 21 ]. There have also been studies on selected patient subgroups including all COVID-19 subjects at high risk of progression [ 23 ], elderly populations [ 22 , 25 ], hematology patients [ 26 ] and solid organ transplant recipients [ 27 ]. However, there has not been any dedicated study focusing on patients with chronic respiratory disease, who are prone to developing severe COVID-19.…”

Section: Discussionmentioning

confidence: 99%

Real-World Study on Effectiveness of Molnupiravir and Nirmatrelvir–Ritonavir in Unvaccinated Patients with Chronic Respiratory Diseases with Confirmed SARS-CoV-2 Infection Managed in Out-Patient Setting

Kwok

Tsoi

Leung

et al. 2023

Viruses

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While molnupiravir (MOV) and nirmatrelvir–ritonavir (NMV-r) were developed for treatment of mild to moderate COVID-19 infection, there has been a lack of data on the efficacy among unvaccinated adult patients with chronic respiratory diseases, including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. A territory-wide retrospective cohort study was conducted in Hong Kong to investigate the efficacy of MOV and NMV-r against severe outcomes of COVID-19 in unvaccinated adult patients with chronic respiratory diseases. A total of 3267 patients were included. NMV-r was effective in preventing respiratory failure (66.6%; 95% CI, 25.6–85.0%, p = 0.007), severe respiratory failure (77.0%; 95% CI, 6.9–94.3%, p = 0.039) with statistical significance, and COVID-19 related hospitalization (43.9%; 95% CI, −1.7–69.0%, p = 0.057) and in-hospital mortality (62.7%; 95% CI, −0.6–86.2, p = 0.051) with borderline statistical significance. MOV was effective in preventing COVID-19 related severe respiratory failure (48.2%; 95% CI 0.5–73.0, p = 0.048) and in-hospital mortality (58.3%; 95% CI 22.9–77.4, p = 0.005) but not hospitalization (p = 0.16) and respiratory failure (p = 0.10). In summary, both NMV-r and MOV are effective for reducing severe outcomes in unvaccinated COVID-19 patients with chronic respiratory diseases.

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Section: Discussionmentioning

confidence: 99%

Real-World Study on Effectiveness of Molnupiravir and Nirmatrelvir–Ritonavir in Unvaccinated Patients with Chronic Respiratory Diseases with Confirmed SARS-CoV-2 Infection Managed in Out-Patient Setting

Kwok

Tsoi

Leung

et al. 2023

Viruses

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“…In the phase 2–3 study of nirmatrelvir/r, the mean age was 46 years (range 18–88) [ 9 ], while in the remdesivir study, it was 50 years (SD 15) [ 11 ]. To the best of our knowledge, only one study has specifically examined the tolerability of nirmatrelvir/r in patients over 80 years of age (16 patients aged 80–89, five patients over 90) [ 27 ]. Other studies involving elderly patients included only a limited number of patients over 80 years of age.…”

Section: Discussionmentioning

confidence: 99%

Antiviral Use in Mild-to-Moderate SARS-CoV-2 Infections during the Omicron Wave in Geriatric Patients

Exquis,

Dionisi,

Samer

et al. 2024

Viruses

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(1) Background: Geriatric patients are at high risk of complications of Coronavirus disease-2019 (COVID-19) and are good candidates for antiviral drugs. (2) Methods: A retrospective study of electronic health records (EHRs) aiming to describe antiviral (nirmatrelvir and ritonavir (nirmatrelvir/r) or remdesivir) use, drug–drug interactions (DDIs) and adverse drug reactions (ADRs) in elderly patients (75 and over), hospitalized with mild-to-moderate COVID-19 between July 2022 and June 2023. (3) Results: Out of 491 patients (mean age: 86.9 years), 180 (36.7%) received nirmatrelvir/r, 78 (15.9%) received remdesivir, and 233 (47.4%) received no antiviral therapy. No association was found between the choice of antiviral and the demographic or medical data. No serious ADR was observed. Nirmatrelvir/r dosage adjustment was inadequate in 65% of patients with renal impairment. In total, 128 patients (71%) on nirmatrelvir/r had potential pharmacokinetic DDIs, with 43 resulting in a possibly related ADR. In the remdesivir group, pharmacodynamic DDIs were more frequent, with QTc prolongation risk in 56 patients (72%). Only 20 patients underwent follow-up ECG, revealing QTc prolongation in 4. (4) Conclusions: There is an underutilization of antivirals despite their justified indications. Nirmatrelvir/r dosage was rarely adjusted to renal function. Dose adjustments and closer monitoring are needed due to the high risk of drug interactions.

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“…As a new drug for COVID-19 management, paxlovid has received widespread attention for its efficacy and safety. The majority of patients with severe COVID-19 are >65 years and have coexisting illnesses, such asobesity and immunological disorders, which place a burden on medical resources 18,19. Therefore, it is crucial to initiate the use of effective medications as soon as possible.…”

mentioning

confidence: 99%

Efficacy and safety of paxlovid (nirmatrelvir/ritonavir) in the treatment of COVID‐19: An updated meta‐analysis and trial sequential analysis

Tian

Yang

Song

et al. 2023

Reviews in Medical Virology

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Our study is aimed to access the efficacy and safety outcomes for coronavirus disease 2019 (COVID‐19) patients treated with Paxlovid. According to inclusion and exclusion criteria, databases were used to retrieve articles from 1 January 2020 to 1 January 2023. Article screening, quality evaluation and data extraction were completed and cross‐checked. The meta‐analysis and trial sequential analysis (TSA) were conducted using RevMan, StataMP, and TSA software. A total of 42 original articles were included. Overall meta‐analysis results showed that for death, hospitalisation, death or hospitalisation, emergency department (ED) visit, intensive care unit (ICU) admission, and extra oxygen requirement outcomes, every odds ratio (OR) was <1 and p < 0.05. For rebound outcome, the OR was >1 and p > 0.05. For adverse events (AEs) outcome, the OR was >1 and p < 0.05. In conclusion, Paxlovid effectively reduced the risks of death, hospitalisation, death or hospitalisation, ED visit, ICU admission, and extra oxygen requirement. There was no significant statistical difference considering rebound, but people should pay attention to possible AEs. However, for rebound and AEs outcomes, observations in certain subgroups suggested conclusions contrary to the overall meta‐analysis. Trial sequential analysis indicated these two outcomes have a risk of false negative or false positive conclusions, so additional original studies are needed for further validation.

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Efficacy and safety of oral antivirals in individuals aged 80 years or older with mild-to-moderate COVID-19: preliminary report from an Italian Prescriber Center

Abstract: T he Coronavirus Disease-19 (COVID-19) pandemic shows no signs of diminishing due to the constant spread of new variants characterized by high contagiousness and capable of

Cited by 3 publications

References 16 publications

Real-World Study on Effectiveness of Molnupiravir and Nirmatrelvir–Ritonavir in Unvaccinated Patients with Chronic Respiratory Diseases with Confirmed SARS-CoV-2 Infection Managed in Out-Patient Setting

Real-World Study on Effectiveness of Molnupiravir and Nirmatrelvir–Ritonavir in Unvaccinated Patients with Chronic Respiratory Diseases with Confirmed SARS-CoV-2 Infection Managed in Out-Patient Setting

Antiviral Use in Mild-to-Moderate SARS-CoV-2 Infections during the Omicron Wave in Geriatric Patients

Efficacy and safety of paxlovid (nirmatrelvir/ritonavir) in the treatment of COVID‐19: An updated meta‐analysis and trial sequential analysis

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