Efficacy of Paxlovid in patients with acute kidney injury who developed COVID-19

Cai et al., Journal of Infection, doi:10.1016/j.jinf.2022.10.002

Dec 2022

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Retrospective 104 AKI patients with COVID-19 in China, 61 treated with paxlovid, showing faster viral clearance and shorter hospitalization with treatment, but no significant difference in morality or ICU admission.

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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risk of death, 9.4% lower, RR 0.91, p = 0.83, treatment 18 of 61 (29.5%), control 14 of 43 (32.6%), NNT 33.

risk of mechanical ventilation, 29.5% lower, RR 0.70, p = 0.58, treatment 8 of 61 (13.1%), control 8 of 43 (18.6%), NNT 18.

risk of ICU admission, 11.2% lower, RR 0.89, p = 0.55, treatment 34 of 61 (55.7%), control 27 of 43 (62.8%), NNT 14.

ICU time, 2.9% lower, relative time 0.97, p = 0.91, treatment 61, control 43.

hospitalization time, 20.0% lower, relative time 0.80, p = 0.01, treatment 61, control 43.

risk of no viral clearance, 47.1% lower, RR 0.53, p = 0.001, treatment 61, control 43.

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.

Cai et al., 31 Dec 2022, retrospective, China, peer-reviewed, 5 authors, study period 7 April, 2022 - 21 June, 2022. Contact: Chexj@126.com, shan_mou@shsmu.edu.cn.

This Paper Paxlovid All

Abstract: Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. Journal of Infection 85 (2022) 702–769 Contents lists available at ScienceDirect Journal of Infection journal homepage: www.elsevier.com/locate/jinf Letters to the Editor Highly Pathogenic Avian Inﬂuenza outbreaks amongst bird populations in Europe - a view from China Dear Editor, A recent letter in this journal described an avian inﬂuenza virus of wild bird origin that is well adapted to a mammalian host, posing a potential threat to animal and human health.1 This is reminiscent of the recent warnings about highly pathogenic avian inﬂuenza (HPAI) in Europe. HPAI, caused by highly pathogenic avian inﬂuenza virus (HPAIV), is a zoonotic disease that seriously endangers the poultry industry, human life, and public health. In October 2022, the European centre for Disease Prevention and Control (ECDC) issued an alert stating that the 2021–2022 HPAI epidemic season in Europe was the largest ever. The latest data (as of September 9, 2022) showed 3573 HPAI cases in wild birds and 2467 outbreaks in poultry, with 48 million birds culled.2 The geographical extent of the outbreak was unprecedented, affecting 37 European countries from the Svalbard islands to southern Portugal and eastern Portugal to Ukraine.3 HPAI data from Europe (Fig. 1) showed both explosive growth and signiﬁcant change in the epidemic strain over the past 3 years (Table 1). In 2018, the main epidemic strain was H5N6, whereas in 2019–2020, H5N8 was more prevalent. In 2021, the dominant strain changed again, and between September 2021 and September 2022, most cases were H5N1 (96.78%, 5311/5489). New strains of HPAIV constantly emerge through mutation, insertion, or recombination of the HA and NA genes.4 Long-distance migration of birds can spread HPAI. A study of the H5N8 HPAI outbreaks in Europe and Japan in 2015 showed Fig. 1. HPAI outbreaks in Europe, 2018–2022. According to ECDC data on HPAI outbreaks in the past 5 years. The 2018 data include HPAI outbreaks reported from November 16, 2017 to November 15, 2018; 2019 data include outbreaks from November 16, 2018 to November 15, 2019; 2020 data include outbreaks from November 16, 2019 to December 27, 2020; 2021 data include outbreaks from December 8, 2020 to December 8, 2021; and 2022 data include outbreaks from December 9, 2021 to September 9, 2022. Table 1 HPAI outbreaks in Europe, 2018–2022. The table shows data for HPAI outbreaks reported by ECDC in the past 5 years. Domestic birds include poultry and captive birds. The main strain refers to the most prevalent HPAI strain reported during that period. (https://www.ecdc.europa.eu/en/publications-data/surveillance report avian inﬂuenza overview). Number of HPAI infected birds Time..

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