Paxlovid reduces the 28-day mortality of patients with COVID-19: a retrospective cohort study
et al., BMC Infectious Diseases, doi:10.1186/s12879-024-09482-y, Aug 2024
Retrospective 1,018 hospitalized COVID-19 patients in China, showing lower 28-day mortality with paxlovid. This study contains significant confounding issues that could potentially account for the entire benefit seen:
The control group includes paxlovid-contraindicated patients (severe renal impairment, hepatic impairment, dangerous drug interactions) that have higher risk, inflating control group mortality. eGFR was not collected. Table 1 confirms lower liver disease in the paxlovid group (2% vs. 6%), showing selection occurred but was not accounted for.
Immortal time bias: patients were classified by whether they received paxlovid "at any point during hospitalization," meaning patients who died before treatment could be initiated are assigned to controls. The timing of paxlovid initiation was not reported.
Vaccination status was not collected or adjusted for.
Quantitative modeling estimates these combined biases could account for the entire observed effect.
Multiple data errors: gender percentage in Table 1 reported as 75% but is 62.7% (151/241), flowchart shows n=799 vs. text n=777 for controls, and the discussion states that paxlovid was associated with "higher mortality" contradicting all results.
Overlapping cohort with at least two companion publications (Liu et al. 2023, Zong et al. 2023) from the same hospitals and time period, without cross-referencing.
Resistance. Variants may be resistant to paxlovid1-8. Use may promote the emergence of variants that weaken host immunity and potentially contribute to long COVID9. Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid10. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy. Black box warning. The FDA notes that severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid11. Kidney and liver injury. Studies show significantly increased risk of acute kidney injury12 and liver injury13,14. Viral rebound. Studies show significantly increased risk of replication-competent viral rebound15-17.
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Zong et al., 1 Aug 2024, retrospective, China, peer-reviewed, 10 authors, study period 8 December, 2022 - 20 January, 2023.
Contact: guosl999@sina.com.
Abstract: Zong et al. BMC Infectious Diseases
(2024) 24:767
https://doi.org/10.1186/s12879-024-09482-y
BMC Infectious Diseases
Open Access
RESEARCH
Paxlovid reduces the 28-day mortality
of patients with COVID-19: a retrospective
cohort study
Kaican Zong1, Li Xu1, Chun Luo2, Chen Luo3, Bin Liu1, Jiacheng Chen1, Huizi Wu1, Zhiqiang Liu1, Rongjuan Zhuang1
and Shuliang Guo1*
Abstract
Purpose In this study, we aim to explore the efficacy of paxlovid on reducing mortality of COVID-19 patients in
clinical setting, especially whether paxlovid modifies the risk of death in these severe and critical patients.
Methods Our retrospective cohort study was conducted on the medical records of patients, consecutively admitted
for COVID-19 to five hospitals in Chongqing, China from Dec 8, 2022 to Jan 20, 2023. Based on whether patients
received paxlovid during their hospitalization, patients were grouped as paxlovid group and non-paxlovid group.
We used 1:1 ratio propensity score matching (PSM) in our study to adjust for confounding factors and differences
between groups. Statistical analysis were performed by SPSS 23.0. The differences in 28-day mortality between these
two groups and its influencing factors were the main results we focused on.
Results There were 1018 patients included in our study cohort. With 1:1 ratio PSM, each of the paxlovid group and
non-paxlovid group included 237 patients. The results showed that patients using paxlovid have a lower 28-day
mortality in overall population either before PSM (OR 0.594, 95% CI 0.385–0.917, p = 0.019) or after PSM (OR 0.458, 95%
CI 0.272–0.774, p = 0.003) with multivariable adjusted logistic regression models. Meanwhile, in severe subgroup, it
showed similar findings.With paxlovid treatment, it showed a significantly lower 28-day mortality in severe subgroup
both before PSM (28% vs.41%, p = 0.008) and after PSM (19% vs.32%, p = 0.007).
Conclusion Paxlovid can significantly reduce the risk of 28-day mortality in overall population and severe subgroup
patients.This study distinguished the severe subgroup patients with COVID-19 who benefit more from paxlovid
treatment.
Keywords Paxlovid, SARS-CoV-2, COVID-19, Mortality, Treatment
*Correspondence:
Shuliang Guo
guosl999@sina.com
1
Department of Respiratory and Critical Care Medicine, The First Affiliated
Hospital, Chongqing Medical University, Chongqing
400016, People’s Republic of China
2
Department of Respiratory and Critical Care Medicine, Affiliated
University Town Hospital of Chongqing Medical University,
Chongqing 401331, People’s Republic of China
3
Department of Respiratory and Critical Care Medicine, The Seventh
People’s Hospital of Chongqing (Affiliated Central Hospital of Chongqing
University of Technology), Chongqing 400054, People’s Republic of China
© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use,
sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and
the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this
article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included
in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the..
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"abstract": "<jats:title>Abstract</jats:title><jats:sec>\n <jats:title>Purpose</jats:title>\n <jats:p>In this study, we aim to explore the efficacy of paxlovid on reducing mortality of COVID-19 patients in clinical setting, especially whether paxlovid modifies the risk of death in these severe and critical patients.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>Our retrospective cohort study was conducted on the medical records of patients, consecutively admitted for COVID-19 to five hospitals in Chongqing, China from Dec 8, 2022 to Jan 20, 2023. Based on whether patients received paxlovid during their hospitalization, patients were grouped as paxlovid group and non-paxlovid group. We used 1:1 ratio propensity score matching (PSM) in our study to adjust for confounding factors and differences between groups. Statistical analysis were performed by SPSS 23.0. The differences in 28-day mortality between these two groups and its influencing factors were the main results we focused on.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>There were 1018 patients included in our study cohort. With 1:1 ratio PSM, each of the paxlovid group and non-paxlovid group included 237 patients. The results showed that patients using paxlovid have a lower 28-day mortality in overall population either before PSM (OR 0.594, 95% CI 0.385–0.917, <jats:italic>p</jats:italic> = 0.019) or after PSM (OR 0.458, 95% CI 0.272–0.774, <jats:italic>p</jats:italic> = 0.003) with multivariable adjusted logistic regression models. Meanwhile, in severe subgroup, it showed similar findings.With paxlovid treatment, it showed a significantly lower 28-day mortality in severe subgroup both before PSM (28% vs.41%, <jats:italic>p</jats:italic> = 0.008) and after PSM (19% vs.32%, <jats:italic>p</jats:italic> = 0.007).</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Conclusion</jats:title>\n <jats:p>Paxlovid can significantly reduce the risk of 28-day mortality in overall population and severe subgroup patients.This study distinguished the severe subgroup patients with COVID-19 who benefit more from paxlovid treatment.</jats:p>\n </jats:sec>",
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