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Real-world nirmatrelvir-ritonavir outpatient treatment in reducing hospitalization for high-risk patients with COVID-19 during Omicron BA.4, BA.5 and XBB subvariants dominance in Malaysia: A retrospective cohort study

Low et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2023.08.003
Oct 2023  
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Mortality 0% Improvement Relative Risk ICU admission 67% Hospitalization 36% Paxlovid for COVID-19  Low et al.  EARLY TREATMENT Is early treatment with paxlovid beneficial for COVID-19? PSM retrospective 31,483 patients in Malaysia (Jul - Nov 2022) Lower hospitalization with paxlovid (p=0.025) c19early.org Low et al., Int. J. Infectious Diseases, Oct 2023 Favorspaxlovid Favorscontrol 0 0.5 1 1.5 2+
Retrospective 31,483 high-risk COVID-19 outpatients in Malaysia showing lower risk of hospitalization with paxlovid.
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.
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.
Kamo et al. show significantly increased risk of acute kidney injury. Resistant variants are likely8,9.
risk of death, no change, RR 1.00, p = 1.00, treatment 1 of 10,483 (0.0%), control 1 of 10,483 (0.0%), propensity score matching.
risk of ICU admission, 66.7% lower, RR 0.33, p = 1.00, treatment 0 of 10,483 (0.0%), control 1 of 10,483 (0.0%), NNT 10483, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), propensity score matching.
risk of hospitalization, 36.0% lower, HR 0.64, p = 0.03, treatment 42 of 10,483 (0.4%), control 67 of 10,483 (0.6%), NNT 419, propensity score matching, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Low et al., 31 Oct 2023, retrospective, Malaysia, peer-reviewed, 13 authors, study period 14 July, 2022 - 14 November, 2022. Contact: evlow@moh.gov.my, evienlow@gmail.com.
This PaperPaxlovidAll
Real-world nirmatrelvir-ritonavir outpatient treatment in reducing hospitalization for high-risk patients with COVID-19 during Omicron BA.4, BA.5 and XBB subvariants dominance in Malaysia: A retrospective cohort study
Ee Vien Low, Mohan Dass Pathmanathan, Suresh Kumar Chidambaram, Wee Ric Kim, Wei Jia Lee, Zhi Wei Teh, Maheshwara Rao Appannan, Shahanizan Mohd Zin, Faizah Muhamad Zin, Samha Bashirah Mohamed Amin, Mastura Ismail, Azah Abdul Samad, Kalaiarasu M Peariasamy
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2023.08.003
Objective: To determine if nirmatrelvir-ritonavir 30 0mg/10 0mg treatment for 5 days in high-risk outpatients with mild to moderate COVID-19 symptoms was associated with a reduction in hospitalization, intensive care unit (ICU) admission, and death. Methods: This 1:1 propensity score matched cohort study from 647 public health clinics in Malaysia included all patients with COVID-19 with positive tests aged 18 years and older, who were eligible for nirmatrelvir-ritonavir treatment within 5 days of illness from July 14, 2022, to November 14, 2022. The exposed group was patients with COVID-19 initiated with nirmatrelvir-ritonavir treatment, whereas those not initiated with the drug served as the control group. Data was analyzed from July 14, 2022 to December 31, 2022. Results: A total of 20,966 COVID-19 high-risk outpatients (n = 10,483 for nirmatrelvir-ritonavir group and n = 10,483 for control group) were included in the study. Nirmatrelvir-ritonavir treatment was associated with a 36% reduction (adjusted hazard ratio 0.64 [95% CI 0.43, 0.94]) in hospitalization compared with those not given the drug. There was a single ICU admission for the control group and one death each was reported in the nirmatrelvir-ritonavir and control group, respectively. Conclusions: Nirmatrelvir-ritonavir treatment was associated with reduced hospitalization in high-risk patients with COVID-19 even in highly vaccinated populations.
Declaration of Competing Interest The authors declare that they have no conflict of interests. Author contributions EVL, MP, SC, KP designed the study. MZ, MZ, SB, WRK, WJL, MR and TTZ collected the data. EVL and MP acquired and analyzed the data. The data was interpreted by all authors. EVL wrote the first draft of the manuscript. All authors reviewed and edited the manuscript. EVL, MD, SC, and KP performed the critical revision of the manuscript for intellectual contact. All authors had full access to all data in the studies and had final responsibility for the decision to submit for publication. Data sharing statement The data that support the findings of this study are available upon reasonable request, and with protocol approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia. Supplementary materials Supplementary material associated with this article can be found, in the online version, at doi: 10.1016/j.ijid.2023.08.003 .
References
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Arbel, Sagy, Hoshen, Battat, Lavie et al., Nirmatrelvir use and severe Covid-19 outcomes during the omicron surge, N Engl J Med, doi:10.1056/NEJMoa2204919
Arumugam, Malaysia to get Covid-19 oral antivriral drug, Paxlovid, this month (NSTTV)
Baker, Bolt, Smith, Piasecki, Conner et al., The relationship of COVID-19 vaccination with mortality among 86,732 hospitalized patients: subpopulations, patient factors, and changes over time, J Gen Intern Med, doi:10.1007/s11606-022-08007-0
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Wong, Lau, Leung, Real-world effectiveness of nirmatrelvirritonavir against BA.4 and BA.5 omicron SARS-CoV-2 variants, Lancet Infect Dis, doi:10.1016/S1473-3099(23)00056-7
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