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Clinical characteristics, outcomes, and risk factors of SARS-CoV-2 breakthrough infections among 572 fully vaccinated (BBIBP-CorV) hospitalized patients

Oct 2023  
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Progression -94% Improvement Relative Risk Progression, azvudine 24% Paxlovid for COVID-19  Liu et al.  LATE TREATMENT Is late treatment with paxlovid beneficial for COVID-19? Retrospective 572 patients in China (December 2022 - January 2023) Higher progression with paxlovid (p=0.007) c19early.org Liu et al., Heliyon, October 2023 Favorspaxlovid Favorscontrol 0 0.5 1 1.5 2+
Retrospective 572 fully vaccinated hospitalized patients in China, showing higher risk with paxlovid use. The composite outcome included intubation, non-invasive respiratory support, ICU admission, and all-cause death. Details for analysis of confounding are not provided. The results for paxlovid can be compared with the alternative antiviral azvudine, which shows lower risk (without statistical significance). Paxlovid was not included in the multivariable analysis (only combined antiviral therapy was used without explanation).
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid1. 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 paxlovid"2.
Kamo et al. show significantly increased risk of acute kidney injury. Resistant variants are likely4,5.
Study covers azvudine and paxlovid.
risk of progression, 93.9% higher, RR 1.94, p = 0.007, treatment 27 of 145 (18.6%), control 41 of 427 (9.6%), intubation, non-invasive respiratory support, ICU admission, and all-cause death.
risk of progression, 24.1% lower, RR 0.76, p = 0.44, treatment 12 of 126 (9.5%), control 56 of 446 (12.6%), NNT 33, intubation, non-invasive respiratory support, ICU admission, and all-cause death.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Liu et al., 21 Oct 2023, retrospective, China, peer-reviewed, 4 authors, study period 5 December, 2022 - 31 January, 2023. Contact: 962881298@qq.com, dengguangtong@outlook.com.
This PaperPaxlovidAll
Clinical characteristics, outcomes, and risk factors of SARS-CoV-2 breakthrough infections among 572 fully vaccinated (BBIBP-CorV) hospitalized patients
Yihuang Liu, Peilin Liu, Yuming Sun, Guangtong Deng
Heliyon, doi:10.1016/j.heliyon.2023.e21387
Background: Breakthrough infections have been widely reported in vaccinated individuals. However, the clinical characteristics, outcomes, and risk factors of SARS-CoV-2 breakthrough infections among fully vaccinated (BBIBP-CorV) hospitalized patients have not yet been fully elucidated. Methods: In the single-center cohort study conducted at Xiangya Hospital of Central South University, we enrolled the hospitalized COVID-19 patients who had received full (2 doses) vaccination with the BBIBP-CorV vaccine between December 5, 2022, and January 31, 2023. We collected and analyzed information related to clinical characteristics, laboratory results, treatments, outcomes and prognostic data. Univariate and multivariable Cox regression were performed to assess the impact of clinical characteristics and laboratory results on the composite outcome (including the initiation of endotracheal intubation, non-invasive respiratory support, intensive care unit admission, and all-cause death). Results: A total of 572 COVID-19 hospitalized patients with fully vaccinated (BBIBP-CorV) were included. The median age of the patients was 66 years (IQR 53, 74). The most common symptoms included fever (347 [60.7 %]), dry cough (401 [70.1 %]), and expectoration (333 [58.2 %]). Among those with pre-existing chronic comorbidities, 44.2 % had hypertension and 20.5 % had diabetes. Laboratory tests revealed that the majority of patients (425/549 [77.4 %]) had normal white blood cell counts. Composite outcome occurred in 11.9 % of patients, with 96.7 % of patients discharged and 3.3 % of patients died. Multivariate Cox regression analyses suggested that the NLR >4 (adjusted HR,]; P = 0.008), D-dimer >0.5 mg/ml (adjusted
Ethics statement Our research has been approved by the institutional review committee of Xiangya Hospital of Central South University (202002024). All patients in the retrospective cohort study were anonymous, and the individual informed consent was not required. Y. Liu et al. Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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Late treatment
is less effective
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