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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

Zhong et al., Frontiers in Medicine, doi:10.3389/fmed.2022.980002, ChiCTR2200060700

Sep 2022

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Retrospective 106 paxlovid and 36 control patients in China, showing faster viral clearance with treatment.

Resistance. Variants may be resistant to paxlovid1-3. Use may promote the emergence of variants that weaken host immunity and potentially contribute to long COVID4.

Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid5. 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"6.

AKI. Kamo et al. show significantly increased risk of acute kidney injury.

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recovery time, 14.7% lower, relative time 0.85, p = 0.26, treatment mean 4.81 (±3.0) n=106, control mean 5.64 (±2.87) n=36.

time to viral-, 15.8% lower, relative time 0.84, p = 0.009, treatment mean 7.51 (±2.79) n=106, control mean 8.92 (±2.61) n=36, viral shedding after enrollment.

time to viral-, 16.1% lower, relative time 0.84, p = 0.001, treatment mean 9.32 (±2.78) n=106, control mean 11.11 (±2.67) n=36, first positive to first of two negative tests.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. Zhou et al., Nirmatrelvir-resistant SARS-CoV-2 variants with high fitness in an infectious cell culture system, Science Advances, doi:10.1126/sciadv.add7197.science.org, doi.org.

2. Jochmans et al., The Substitutions L50F, E166A, and L167F in SARS-CoV-2 3CLpro Are Selected by a Protease Inhibitor In Vitro and Confer Resistance To Nirmatrelvir, mBio, doi:10.1128/mbio.02815-22.asm.org, doi.org.

3. Lopez et al., SARS-CoV-2 Resistance to Small Molecule Inhibitors, Current Clinical Microbiology Reports, doi:10.1007/s40588-024-00229-6.springer.com, doi.org.

4. Thomas et al., Nirmatrelvir-Resistant Mutations in SARS-CoV-2 Mpro Enhance Host Immune Evasion via Cleavage of NF-κB Essential Modulator, bioRxiv, doi:10.1101/2024.10.18.619137.biorxiv.org, doi.org.

5. Hoertel et al., Prevalence of Contraindications to Nirmatrelvir-Ritonavir Among Hospitalized Patients With COVID-19 at Risk for Progression to Severe Disease, JAMA Network Open, doi:10.1001/jamanetworkopen.2022.42140.jamanetwork.com, doi.org.

6. FDA, Fact sheet for healthcare providers: emergency use authorization for paxlovid, www.fda.gov/media/155050/download.fda.gov.

7. Kamo et al., Association of Antiviral Drugs for the Treatment of COVID-19 With Acute Renal Failure, In Vivo, doi:10.21873/invivo.13637.iiarjournals.org, doi.org.

Zhong et al., 6 Sep 2022, retrospective, China, peer-reviewed, 12 authors, study period 24 April, 2022 - 28 May, 2022, trial ChiCTR2200060700. Contact: snailliyi@163.com, zhangwench88@hotmail.com, zhuchuanlong@jsph.org.cn.

This Paper Paxlovid All

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

Weijie Zhong, Xiufeng Jiang, Xiaosheng Yang, Tiantong Feng, Zhixin Duan, Wei Wang, Zhaoliang Sun, Lingyan Chen, Xin Nie, Chuanlong Zhu, Wenchuan Zhang, Yi Li

Frontiers in Medicine, doi:10.3389/fmed.2022.980002

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

Ethics statement The studies involving human participants were reviewed and approved by the Ethics Committee of the Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine (No. SH9H-2022-T112-2). Moreover, it was registered at the Chinese Clinical Trial Registry (ChiCTR2200060700). The patients/participants provided their written informed consent to participate in this study. Author contributions WJZ, XJ, XY, ZD, WW, ZS, WCZ, LC, and YL collected the epidemiological and clinical data. WCZ and YL were responsible for enrollment, clinical monitoring, funding, study conception and design, and revising and submitting the final manuscript. XY, ZD, XJ, and YL were responsible for the distribution and storage of medicines. WJZ, TF, XN, LC, CZ, YL, and WCZ were responsible for statistical data. WJZ, XJ, XY, TF, CZ, and YL drafted the manuscript. All authors contributed to the article and approved the submitted version. Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the..

References

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Chilamakuri, Agarwal, COVID-19: characteristics and therapeutics, Cells, doi:10.3390/cells10020206

Dejnirattisai, Huo, Zhou, Zahradník, Supasa et al., SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses, Cell

Fan, Li, Zhang, Wan, Zhang et al., SARS-CoV-2 Omicron variant: recent progress and future perspectives, Signal Transduct Target Ther, doi:10.1038/s41392-022-00997-x

Fiolet, Kherabi, Macdonald, Ghosn, Peiffer-Smadja, Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness against SARS-CoV-2 and variants of concern: a narrative review, Clin Microbiol Infect, doi:10.1016/j.cmi.2021.10.005

Garcia-Beltran, Denis, Hoelzemer, Lam, Nitido et al., mRNA-based COVID-19 vaccine boosters induce neutralizing immunity against SARS-CoV-2 Omicron variant, doi:10.1101/2021.12.14.21267755

Hammond, Leister-Tebbe, Gardner, Abreu, Wisemandle, Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2118542

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Ledford, How severe are Omicron infections?, Nature, doi:10.1038/d41586-021-03794-8

Marzi, Vakil, Bahmanyar, Zarenezhad, Paxlovid: mechanism of action, synthesis, and in silico study, Biomed Res Int, doi:10.1155/2022/7341493

Mistry, Barmania, Mellet, Peta, Strydom et al., SARS-CoV-2 variants, vaccines, and host immunity, Front Immunol, doi:10.3389/fimmu.2021.809244

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The nucleic acid shedding time was the primary ' 'endpoint.ResultsAccording to ' 'the inclusion criteria, 142 patients infected with omicron variants were enrolled, 36 ' 'patients who did not receive paxlovid were assigned to the control group, and 106 were in the ' 'Paxlovid group. The baseline characteristics were similar in either group. No significant ' 'difference in BMI, age, time from onset to patient enrollment, the severity on first ' 'admission, vaccination status, comorbidity, first symptoms, and laboratory results were ' 'recorded. 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