The efficacy of paxlovid in elderly patients infected with SARS-CoV-2 omicron variants: Results of a non-randomized clinical trial

Zhong, Weijie; Jiang, Xiufeng; Yang, Xiaosheng; Feng, Tiantong; Duan, Zhixin; Wang, Wei; Sun, Zhao-Liang; Chen, Lingyan; Nie, Xin; Zhu, Chuanlong; Zhang, Wenchuan; Li, Yang

doi:10.3389/fmed.2022.980002

Cited by 21 publications

(16 citation statements)

References 27 publications

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“…The differences in age distributions, related chronic diseases, vaccination rates, study designs, and SARS-CoV-2 variants may have contributed to the inconsistency between these studies. In a previous study related to the effect of paxlovid on the elderly patients with mean 76.37 years old who were infected with SARS-CoV-2 omicron variants, the nucleic acid shedding time was significantly reduced [ 25 ], which is consistent with the result of our research. Meanwhile we also found that the nucleic acid Ct value at admission was low in the elderly patients.…”

Section: Discussionsupporting

confidence: 92%

Safety and Efficacy of Paxlovid Against Omicron Variants of Coronavirus Disease 2019 in Elderly Patients

et al. 2023

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Introduction Elderly patients are the most affected and vulnerable to COVID-19 and effective therapeutic interventions are urgently required. We clarified the safety and efficacy of Paxlovid in the treatment of elderly patients with coronavirus disease 2019 (COVID-19). Methods Patients aged over 60 years and with mild to moderate COVID-19 were admitted to the Zhongshan Hospital MinHang MeiLong Branch, Fudan University and received either Paxlovid treatment or only conventional therapy, between April 1 and May 31, 2022. Viral shedding time, duration of hospital stay, disease progression, and adverse events were analyzed, and multivariate Cox regression analysis was performed to detect the independent high-risk factors for COVID-19 progression in the patients. Results A total of 163 (82 and 81 in the treatment and control groups, respectively) patients had a median age of 82 (71–89) years, and 89.0% had at least one concomitant disease. The duration of hospitalization reduced from 15 to 13 days, and viral shedding time reduced from 20 to 16.5 days after Paxlovid treatment. The differences of these two variables between the groups were significant ( p < 0.01). Moreover, no serious adverse events or obvious changes in laboratory test results were observed in patients treated with Paxlovid. One patient (1.2%) treated with Paxlovid experienced rebound 56 days after negative measurement. Multivariate analysis showed that Paxlovid therapy, age, hemoglobin, and nucleic acid Ct values at admission were independent risk factors for hospitalization within 14 days, and the differences were significant ( p < 0.01). Conclusion The use of Paxlovid in elderly patients may promote recovery from COVID-19 and reduce the viral load without adverse events. Clinical trial registration www.ClinicalTrials.gov , ID: ChiCTR2200066990. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-023-00760-x.

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Section: Discussionsupporting

confidence: 92%

Safety and Efficacy of Paxlovid Against Omicron Variants of Coronavirus Disease 2019 in Elderly Patients

et al. 2023

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“…The pooled estimate of seven studies 15,16,19,21,26,31,33 involving 1187 patients showed a significant difference between the Paxlovid and no-Paxlovid groups in terms of PCR-negative conversion time (MD = −2.46; 95% CI: −4.31 to −0.61; p = 0.009) (Figure 2D).…”

Section: Pcr-negative Conversion Timementioning

confidence: 99%

Efficacy and safety of nirmatrelvir/ritonavir (Paxlovid) for COVID‐19: A rapid review and meta‐analysis

Amani

2023

Journal of Medical Virology

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This study aimed to examine the efficacy and safety of nirmatrelvir/ritonavir (Paxlovid) for coronavirus disease 2019 (COVID‐19). PubMed, Cochrane Library, Web of Science, medRxiv, and Google Scholar were searched to identify the relevant evidence up to November 10, 2022. The reference lists of key studies were also scanned to find additional records. The quality of the studies was evaluated using the Cochrane tools for assessing the risk of bias. The Comprehensive Meta‐Analysis software version 3.0 was employed for data analysis. Twenty‐three studies involving 314 353 patients were included in the analysis. The findings of the meta‐analysis showed a significant difference between the Paxlovid and no‐Paxlovid groups in terms of mortality rate (odds ratio [OR] = 0.25; 95% confidence interval [CI]: 0.14–0.45), hospitalization rate (OR = 0.40; 95% CI: 0.24–0.69), polymerase chain reaction negative conversion time (mean difference [MD] = −2.46; 95% CI: −4.31 to −0.61), and hospitalization or death rate (OR = 0.17; 95% CI: 0.06–0.46). However, no significant difference was observed between the two groups in terms of COVID‐19 rebound (OR = 0.84; 95% CI: 0.67–1.04), emergency department visit (OR = 0.75; 95% CI: 0.45–1.24), intensive care unit admission (OR = 0.37; 95% CI: 0.13–1.01), and adverse events (OR = 2.20; 95% CI: 0.42–11.47). The results of the present study support the efficacy and safety of Paxlovid in the treatment of patients with COVID‐19. Further research is needed to investigate the COVID‐19 rebound after Paxlovid treatment.

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“…In a double‐blind, placebo‐controlled phase II/III trial conducted by Pfizer Inc. Paxlovid™ has been found to reduce the hospitalization and death risk by 89% when administered within 3 days of symptom onset ( Table 4 ). Notably, the death rate was found to reduce with high statistical significance (p < 0.0001) [ 151 , 152 ]. A recent meta-analysis of 18,568 patient data from 41 RCTs comparing the efficacy of antiviral drugs in patients with COVID-19 found that malnupiravir and nimatrevir-ritonavir (Paxovid™) significantly reduced the risk of hospitalization and death.…”

Section: Variant Independent Therapiesmentioning

confidence: 99%

Insight into SARS-CoV-2 Omicron variant immune escape possibility and variant independent potential therapeutic opportunities

Alam

2023

Heliyon

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The efficacy of paxlovid in elderly patients infected with SARS-CoV-2 omicron variants: Results of a non-randomized clinical trial

Cited by 21 publications

References 27 publications

Safety and Efficacy of Paxlovid Against Omicron Variants of Coronavirus Disease 2019 in Elderly Patients

Safety and Efficacy of Paxlovid Against Omicron Variants of Coronavirus Disease 2019 in Elderly Patients

Efficacy and safety of nirmatrelvir/ritonavir (Paxlovid) for COVID‐19: A rapid review and meta‐analysis

Insight into SARS-CoV-2 Omicron variant immune escape possibility and variant independent potential therapeutic opportunities

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