Real-world effectiveness of nirmatrelvir/ritonavir against COVID-19 hospitalisations and severe COVID-19 in community-dwelling elderly Singaporeans during Omicron BA.2, BA.4/5 and XBB transmission
et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2023.06.016, Jun 2023
Retrospective 3,959 paxlovid patients and 139,379 untreated controls, showing lower hospitalization with treatment. Contraindicted patients were excluded.
Confounding by treatment propensity. This study analyzes a population
where only a fraction of eligible patients received the treatment. Patients
receiving treatment may be more likely to follow other recommendations, more
likely to receive additional care, and more likely to use additional
treatments that are not tracked in the data (e.g., nasal/oral hygiene1,2, vitamin D3, etc.) — either because the physician
recommending paxlovid also recommended them, or
because the patient seeking out paxlovid is more
likely to be familiar with the efficacy of additional treatments and more
likely to take the time to use them.
Malden et al. confirm significant bias in the use of paxlovid, showing that
treated patients are more likely to be from affluent neighborhoods, be more
health-conscious, and have better access to care.
Therefore, these kind of studies may
overestimate the efficacy of treatments.
Resistance. Variants may be resistant to paxlovid5-12. Use may promote the emergence of variants that weaken host immunity and potentially contribute to long COVID13. Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid14. 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 paxlovid15. Kidney and liver injury. Studies show significantly increased risk of acute kidney injury16 and liver injury17.
|
risk of severe case, 14.0% lower, OR 0.86, p = 0.63, treatment 3,959, control 139,739, adjusted per study, multivariable, RR approximated with OR.
|
|
risk of hospitalization, 35.0% lower, OR 0.65, p = 0.002, treatment 3,959, control 139,739, adjusted per study, multivariable, RR approximated with OR.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
4.
Malden et al., Predictors of nirmatrelvir–ritonavir receipt among COVID-19 patients in a large US health system, Scientific Reports, doi:10.1038/s41598-024-57633-7.
5.
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.
6.
Moghadasi et al., Rapid resistance profiling of SARS-CoV-2 protease inhibitors, npj Antimicrobials and Resistance, doi:10.1038/s44259-023-00009-0.
7.
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.
8.
Lopez et al., SARS-CoV-2 Resistance to Small Molecule Inhibitors, Current Clinical Microbiology Reports, doi:10.1007/s40588-024-00229-6.
9.
Zvornicanin et al., Molecular Mechanisms of Drug Resistance and Compensation in SARS-CoV-2 Main Protease: The Interplay Between E166 and L50, bioRxiv, doi:10.1101/2025.01.24.634813.
10.
Vukovikj et al., Impact of SARS-CoV-2 variant mutations on susceptibility to monoclonal antibodies and antiviral drugs: a non-systematic review, April 2022 to October 2024, Eurosurveillance, doi:10.2807/1560-7917.ES.2025.30.10.2400252.
11.
Deschenes et al., Functional and structural characterization of treatment-emergent nirmatrelvir resistance mutations at low frequencies in the main protease (Mpro) reveals a unique evolutionary route for SARS-CoV-2 to gain resistance, The Journal of Infectious Diseases, doi:10.1093/infdis/jiaf294.
12.
Zhou (B) et al., SARS-CoV-2 Mpro inhibitor ensitrelvir: asymmetrical cross-resistance with nirmatrelvir and emerging resistance hotspots, Emerging Microbes & Infections, doi:10.1080/22221751.2025.2552716.
13.
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.
14.
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.
15.
FDA, Fact sheet for healthcare providers: emergency use authorization for paxlovid, www.fda.gov/media/155050/download.
Wee et al., 17 Jun 2023, retrospective, Singapore, peer-reviewed, 11 authors, study period 18 March, 2022 - 31 December, 2022.
Contact: ian.wee.l.e@singhealth.com.sg.
Real-world effectiveness of nirmatrelvir/ritonavir against COVID-19 hospitalisations and severe COVID-19 in community-dwelling elderly Singaporeans during Omicron BA.2, BA.4/5 and XBB transmission
Clinical Microbiology and Infection, doi:10.1016/j.cmi.2023.06.016
Real-world effectiveness of nirmatrelvir/ritonavir against COVID-19 hospitalisations and severe COVID-19 in community-dwelling elderly Singaporeans during Omicron BA.2, BA.4/5 and XBB transmission
Declarations
Declaration of interests The authors report no conflicts of interest.
Contribution statement LEW contributed to literature search and writing of the manuscript. ATT, CC, BEY, BW, RL, CLL, JT, SV, DCL and KBT contributed to critical review and editing of the manuscript. DCL and KBT provided supervision. KBT, ATT contributed to study design, data collection, and data analysis. All authors had full access to all the data in the study and take responsibility for the decision to submit for publication. KBT and ATT directly accessed and verified the underlying data reported in the manuscript. J o u r n a l P r e -p r o o f
References
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